CalFeed is a place to Share and Discover Online Events. This feed contains the latest Front Page Events. http://www.calfeed.com This 7-hr virtual seminar on Payroll 201 provides high-level training on topics critical to the intermediate payroll professional. It will increase your knowledge of payroll procedures and compliance regulations beyond the mere basic skills. http://www.calfeed.com/events/1439-Critical-Factors-and-Complexities-in-Payroll-201 http://www.calfeed.com/1439 Thu, 15 Dec 2011 05:43:10 +0000 Explore the many facets of Indoor Air Quality and present easy ways to make the daycare environment healthier and safer for the children as well as the staff.
Beat the sniffles, runny noses, stuffiness and potential long-term health effects with simple yet effective steps.
• How Pollutants Affect Children, Caregivers, Parents
• Simple, Sound Solutions
• Air Cleaning Technologies http://www.calfeed.com/events/1492-Webinar---Cleaner-Air-–-Brighter-Minds-Indoor-Air-Quality-Management-in-Daycare-Facilities. http://www.calfeed.com/1492 Tue, 17 Jan 2012 20:55:36 +0000 The FDA, with assistance from the FTC, has become increasingly aware of the large amount of dietary supplements that have come onto the market since the passage of the Dietary Supplement Health and Education Act in 1994. A growing public demand for supplements, along with a relatively relaxed pre-market approval process, has resulted in a flurry of companies creating and marketing their own dietary supplements in the United States. With FDA beginning to take a stronger stance on Dietary Supplement enforcement, it is important for companies to verify that their products comply with the latest regulations and provisions.



This 90 minute live, interactive webinar will review the dietary supplement regulations and discuss how to verify that your products are compliant, while citing differences with food and drug regulations. We will also cover what qualifies a material as a dietary ingredient, considerations for manufacturers and distributors, requirements for compliant labelling and acceptable marketing claims. An update on FDA’s draft guidance for New Dietary Ingredients and an overview of the Dietary Supplement Labelling Act (both introduced in 2011) will also be discussed.



At the conclusion of this 75 minute presentation, there will be a 15 minute Q&A session with the speaker.





Agenda:

I. Dietary Supplement Overview

-What is a dietary supplement?

- Supplements vs. Pharmaceuticals/OTC Drugs/Conventional Foods



II. Regulatory Structure

-FDA Structure regarding Dietary Supplements

-Industry Groups



III. History of Dietary Supplement Regulation

-Early History & DSHEA

-Code of Federal Regulations



IV. Manufacturing Considerations

-Company & Facility Registration

-GMP Requirements



V. Dietary Ingredients

-What qualifies as a dietary ingredient?

-Old dietary ingredients vs. New dietary ingredients

-New Dietary Ingredient Notification (NDIN)

-Updated New Dietary Ingredient Guidance from FDA



VI. Labeling Considerations

-Display Panels & Layout

-Supplement Facts Panel Requirements

-Labeling Claim

-Health vs. Disease vs. Structure/Function claims

-Disclaimers/Substantiation

-Notification of labeling claims to FDA

-Dietary Supplement Labeling Act



VII. Advertising Considerations

-FDA vs. FTC jurisdiction & enforcement

-Expressed vs. Implied Claims

-Disclosures & Claim Substantiation

-Testimonials



VIII. Questions & Answers





Who Should Attend?



- Executives of Dietary Supplement companies

- Regulatory Compliance Professionals

- Quality Assurance Professionals

- Dietary Supplement Manufacturers

- Dietary Supplement Distributors
- Sales/Marketing Personnel


About Speaker

Robert J. Russell, is President and CEO of RJR Consulting, Inc, a leading Global Regulatory Consulting firm focusing on assisting the Life Science Industry. Prior to founding the firm in 2000, Mr. Russell had over 27 years of experience in CMC, Global Business Development and Regulatory Compliance for pharmaceuticals, biologics, medical devices and combination products. The company has an office in Brussels, Belgium where they interact with the European Commission and the Competent Authorities across the EU. Country establishment, marketing authorizations, variations and license renewals are core competencies of the course director. Mr. Russell has received a B.S. and M.S.in Chemistry. http://www.calfeed.com/events/1470-Dietary-Supplement-Regulatory-Compliance-in-the-United-States:-Labeling-Product-Claims-&-Updates-from-the-FDA http://www.calfeed.com/1470 Fri, 13 Jan 2012 04:26:47 +0000 MCS (Multiple Chemical Sensitivity) can affect people of all ages and backgrounds. It is characterized by extreme sensitivities and allergic-type reactions to even the slightest trace of chemicals.

In this webinar, we will explore the many facets of Indoor Air Quality and we will present easy ways to make the Indoor Air Environment healthier and safer for people afflicted with MCS symptoms, with simple yet effective steps.

• What is an MCS Air Quality Program
• Sources of Poor IAQ
• How can Pollutants Affect Me
• Simple, Sound Solutions
• Overview of Air Cleaning Technologies
• Advantages of a Healthy Indoor Environment
• Benefits of Cleaner Air http://www.calfeed.com/events/1493-Take-control-of-your-Air-Quality-and-Multiple-Chemical-Sensitivities http://www.calfeed.com/1493 Mon, 23 Jan 2012 18:53:31 +0000 This 3-hr training will discuss medical device regulations and law in the US, Europe and Canada.

Why You Should Attend:

The global regulation of medical devices is rapidly evolving, integrating the regulatory systems of the most advanced medical device regulations. http://www.calfeed.com/events/1420-Medical-Device-Regulations-and-Law-in-the-US-EU-and-Canada http://www.calfeed.com/1420 Wed, 14 Dec 2011 10:39:46 +0000 Overview : The discussion will include focused discussion on inclusion and diversity and the value add to business activity that comes from using a global mindset to lead teams and the opportunity for creative and innovative thinking that the mindset can foster.

In today's business world it is becoming more important to be able to work effectively across cultures. However a more global mindset is really about building an attitude of inclusiveness so that an organization can not only survive but thrive with the diversity that is growing in our workplaces that include different nationalities but now also includes or will soon include 5 generations. As the world economy staggers and recovers and as we continue to understand how closely all economies of the world are linked; businesses must understand how a global mindset will assist them.

In our 90 minute program we will explore the topic in three parts and examine what each one involves and why it is important to the future of your business. They are:

Personal
In the Business
As part of the company culture

The future is more complex and integrated. With a cell phone in almost every hand around the world, we have more opportunity every day to be more involved in global events. Information that took sometimes years to reach around the world now reaches in second. Just that fact alone changes the way the world interacts. It is important for us to understand the dynamics and impacts of this global information at our fingertips. It is not as easy for media to "spin" because we can see and hear the immediate truth of the situation. This opens up all kinds of avenues for virtual leadership and management. It depends greatly on a global mindset.

There is tremendous value and opportunity in virtual global management, when done well. We can learn and grow from understanding how and why things work the way they do in other countries. In that quest, it is important to be able to make the voice on the other end of the line "real" and be able to relate to them in a context that is meaningful for us and for them. That is where we can enhance our relationship and opportunities for success.

Areas Covered In the Session:

Global mindset defined - what does it mean and look like in action
Do I want a global mind set - what is in it for me?
How do I build my own - what can I do to facilitate my personal learning and build my perspective?
How important is a global mindset for my business – what business advantage does it bring to my team? My company?
How do I assist in building an attitude of inclusivity that will nurture a global mindset in my tem? What role do I play in supporting the growth of a global mindset on my team?
Is a global mindset important for my company? Will it be useful and important to our business? How does it contribute to sustainability?
What would a global mindset look like if it was part of our company culture? Do we have to change our values or incorporate a new “attitude” in our values?
How can I assist? How can I contribute?

These learning points will be explored and discussed during the webinar with examples that will support the discussion.

Who will benefit:

CHRO
Business Leaders (VP)
Risk Managers http://www.calfeed.com/events/1485-Building-a-Global-Mindset---Webinar-By-TrainHR http://www.calfeed.com/1485 Mon, 16 Jan 2012 10:44:27 +0000 Adopting a security engineering mindset to application development means that security is considered from project inception through deployment. This webcast will present six key security engineering activities that development teams can leverage to refine and extend their existing life cycle activities. Attendees will learn best practices for integration and how to adopt these activities incrementally. http://www.calfeed.com/events/1495-Six-Key-Security-Engineering-Activities-for-Web-Applications http://www.calfeed.com/1495 Thu, 26 Jan 2012 14:12:23 +0000 This FDA cGMP training webinar will discuss US FDA’s approach to cGMP Audits and expectations from companies. It will also evaluate chief concern areas of cGMP compliance audit and anticipatory emphasis changes as per new regulatory climate. http://www.calfeed.com/events/1415-Prepare-for-Tougher-U.S.-FDA-cGMP-Compliance-Audits http://www.calfeed.com/1415 Wed, 14 Dec 2011 10:23:08 +0000 This Process Validation training will look at the underlying statistical concepts to perform an effective process validation. The webinar examine elements of the FDA regulations for process validation (21 CFR §820.75) as well as the corresponding requirements in ISO 13485. http://www.calfeed.com/events/1421-Medical-Device-Process-Validation---Statistical-Considerations http://www.calfeed.com/1421 Wed, 14 Dec 2011 10:42:13 +0000 This Listeria Prevention training will cover HAACP requisites as well as GMP and Sanitation programs to address areas of possible listeria contamination and methods to eradicate them. http://www.calfeed.com/events/1509-Preventing-Listeria-in-RTE-processing-plants http://www.calfeed.com/1509 Fri, 27 Jan 2012 07:28:07 +0000 This 90-minute Internal Audit webinar will cover the three foundational elements that support an effective Internal Audit program - establishing Internal Audit Program objectives, developing audit plans, and writing effective non-compliances.

Why Should You Attend:

Internal auditing drives continual improvement and reminds everyone that Quality comes first! Auditing is an assessment tool that provides a reliable performance indicator of your organization’s system and processes. http://www.calfeed.com/events/1531-Setting-up-an-effective-Internal-Audit-Program http://www.calfeed.com/1531 Mon, 30 Jan 2012 08:35:49 +0000 Course Description
When International Financial Reporting Standards (IFRS) come into effect January 1, 2015, public companies will have to change how they account for long-lived tangible assets on their financial statements. But exactly how do you do it?

The first day of this interactive workshop will consist of an introduction and overview of IFRS. The fundamental change is one of principles-based decisions replacing rules-based decisions. A thorough understanding of these principles is a pre-requisite to undertaking the transition from GAAP to IFRS.

The second day examines the steps involved in accounting for long-lived tangible assets, the options available and their impact, the expanded disclosures, and an examination of how the choice of IFRS policies affects financial statements for years to come.

Companies and accountants will be expected to first record the acquisition of long-lived assets, assess the value at which they are presented on future financial statements, and work out the allocation of the cost of these assets over future reporting periods.

This hands-on workshop will provide you with easy-to-follow guidelines that will ensure that you can meet the deadline for complying with these new standards.

Learning Objectives:

This workshop provides you with a solid understanding of IFRS principles and will outline the step-by-step procedure for implementation of IFRS policies for Property, Plant, and Equipment. It will examine the many factors that companies need to carefully consider when implementing International Financial Reporting Standards.

Areas Covered:

IFRS: The basics
GAAP vs. IFRS: asset valuation differences
How impairment and revaluation of long-lived tangible assets are accounted for under IFRS
Scope and applicability of the relevant standards
Sizing up the impacts of implementation: questions you need to ask
Planning the approach: accounting policies and decision criteria
Mixed asset valuation model: revaluation and historical cost
Concepts and rules for Property, Plant, and Equipment
Revaluation methods under IFRS
Impairment of tangible long-lived assets
Retirements and other disposals of long-lived assets
Nonmonetary (exchange) transactions
Disclosure requirements
Financial statement presentation

Who will benefit:

CFO's
Financial Reporting Managers
Financial Analysts
Stock analysts
Certified Public Accountants
Risk analysts http://www.calfeed.com/events/1317-IFRS-for-Fixed-Assets--Property-Plant-and-Equipment http://www.calfeed.com/1317 Thu, 10 Nov 2011 09:44:57 +0000 This 4-hr Latin America Regulatory compliance requirements training/webinar will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Latin America.

Why Should You Attend:

This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Latin America. http://www.calfeed.com/events/1361-Latin-America:-Regulatory-Compliance-Requirements-for-Life-Science-Products-(Focus:-Brazil-Mexico-Argentina) http://www.calfeed.com/1361 Fri, 11 Nov 2011 11:00:45 +0000 This 4-hr training will address both the legal and psychological issues that often arise while dealing with Psychiatric Disabilities at Work.

Why Should You Attend:

The recent amendments to the A.D.A. have a significant impact on the rights of mentally employees as well as the responsibilities of employers. http://www.calfeed.com/events/1381-Legal-and-Practical-guidelines-for-Dealing-with-Psychiatric-Disabilities-at-Work:-Navigating-the-A.D.A.-Worker’s-Comp-and-the-FMLA http://www.calfeed.com/1381 Fri, 11 Nov 2011 11:57:48 +0000 This 90-minute webinar will provide guidelines for bioassay validation and regulatory documentation, the steps for technology transfer and commercial validation show how to implement the new USP chapters 1032, 1033 and 1034. http://www.calfeed.com/events/1409-Life-Cycle-Validation-of-GMP-Potency-Bioassays http://www.calfeed.com/1409 Wed, 14 Dec 2011 09:59:39 +0000 This Recruiting on a Limited Budget training will cover costs involved in the recruiting process and indicate areas that can be reduced or eliminated by deviating from the traditional methods used. http://www.calfeed.com/events/1440-Recruiting-on-a-Limited-Budget:-Proven-Low-and-No-Cost-Tools-and-Approaches http://www.calfeed.com/1440 Thu, 15 Dec 2011 06:04:14 +0000 This training will show how the CobIT and ITIL Frameworks can be aligned to enable process maturity analysis, adherence with compliance mandates and process improvement initiatives.

Why Should You Attend:

Let’s face it; those of us who have been working on implementing ITIL have obtained plenty of knowledge on HOW to work through the processes for successful ITSM processes. http://www.calfeed.com/events/1519-COBIT-and-ITIL-Framework-Alignment-to-Improve-the-IT-Organization-while-Improving-Compliance http://www.calfeed.com/1519 Mon, 30 Jan 2012 07:53:33 +0000 This 90-minute training will discuss recent OFCCP enforcement trends and regulatory initiatives and review these against your current practices and procedures to ensure your company is audit ready http://www.calfeed.com/events/1441-Affirmative-Action-and-Recent-Trends-within-the-OFCCP http://www.calfeed.com/1441 Thu, 15 Dec 2011 06:18:09 +0000 This OSHA Inspection and Accident Investigation training will provide practical tips for safety professionals and managers on what the OSHA inspectors will look for, how to respond to a letter of complaint, how employees and unions figure into the inspection equation, and what you must do to expedite the inspection and help resolve issues before they become major problems. http://www.calfeed.com/events/1448-Managing-OSHA-Inspections-and-Accident-Investigations http://www.calfeed.com/1448 Thu, 15 Dec 2011 06:49:26 +0000 In this 2-hr webinar you will learn how to differentiate and draw boundaries for GMP and GLP practices if done in same laboratory and how to transition a procedure in development to one used routinely.

Why Should You Attend:

If a laboratory is dedicated either to GMP testing and validation activities or to method and procedure development and validation, then the laboratory is responsible for following the appropriate CFRs. http://www.calfeed.com/events/1524-Does-your-pharmaceutical-lab-have-GMP-and-non-GMP-functions? http://www.calfeed.com/1524 Mon, 30 Jan 2012 08:10:44 +0000 Creating effective webinars takes planning, organizational skills, diplomacy and specialized expertise. This 45 minute educational webinar discusses what it takes to plan, prepare and host webinars as part of a business or member outreach program.

If you can’t attend the webinar, register anyway, and we will send you a link to a free replay. http://www.calfeed.com/events/1541-Planning-Your-First-Webinar---The-What-Why-and-How-to-Make-it-a-Success http://www.calfeed.com/1541 Wed, 01 Feb 2012 15:55:17 +0000 This webinar on addressing fungal and bacterial spore outbreaks will discuss case studies on excursion investigations and show how facility design, personnel practices and cleaning and disinfection effect excursion investigations. http://www.calfeed.com/events/1507-Solutions-for-Addressing-Fungal-and-Bacterial-Spore-Outbreaks-in-Pharmaceutical-Biotech-and-Medical-Device-Operations http://www.calfeed.com/1507 Fri, 27 Jan 2012 07:22:24 +0000 This US FDA draft guidance documentation webinar/ training will give an insider’s insight into the new guidance and regulation and discuss the rationale for such.

The US FDA has issued a draft guidance document outlining a suggested approach to complying with current good manufacturing practice (CGMP) requirements for drugs intended soley in Phase 1 studies. http://www.calfeed.com/events/1432-FDA’s-Current-Thinking-for-Industry-cGMPs-for-Phase-1-INDs http://www.calfeed.com/1432 Wed, 14 Dec 2011 12:06:59 +0000 Team members might resent or even undermine group efforts when one individual's bad behavior is tolerated. Others try hard but fail. Only through a holistic approach to performance can maximum productivity be achieved. Therefore, managing what individuals do everyday, tracking the results that come from their contributions, and including how they work with others are all necessary to ensure performance success. Make sure that employees are the first step in the quality assurance process.

Learn how to train employees to indentify the key variables that identify success. Build a support system that does not allow employees to fail, languish, or to waste time on unproductive tasks. Instead of asking employees to show up for 8 hours a day, design a work environment that challenges them to do their very best work each day. Unleash employee excitement and potential by getting them involved, supporting them, and directing them in a new and novel way that respects that talents and abilities of today's knowledge workers.

Why you should attend: When does a focus on results undermine productivity? Can employees complete the right way and on time but unintentionally sabotage the organization? Do managers sometimes ignore ticking time bombs that poison the area around them by not dealing with behavioral issues? The only way to be an effective manager is to manage performance holistically by balancing the focus on efforts, outcomes, and behaviors. Learn how to ensure that each assignment, your supervisor techniques, your performance management system, and your compensation system are all aligned and support the kind of performance that you produce lasting results. Don't pay employees to get results and allow them to cannibalize future sales. Hold employees accountable for what they do, what they fail to do, and how they do it. Ensure that the work smart, safe, efficiently and effectively. Do not allow employees to cut corners, undermine coworkers, or fail to follow policies and procedures. Build a performance management system and performance management system that complement one another and ensure that each employee is held to high standards.

Areas Covered in the Session:

Define what excellent performance "looks like" from the employee's perspective
Diagnose performance problems effectively
Select the proper management intervention to correct poor performance
Use the right management tools to keep employees on track
Train managers to help employees be more productive
Review or revamp your performance management system
Ensuring Incentive Plans are designed to support the "actual" results you seek

Who Will Benefit:

Managers
Supervisors
HR Managers
Directors
Coordinators
Vice Presidents http://www.calfeed.com/events/1459-Efforts-Outcomes-and-Behaviors:-Improving-Productivity-with-a-Management-Technique-that-Can-Handle-Good-Bad-and-Ugly-Employee-Performance---Webinar-By-TrainHR http://www.calfeed.com/1459 Mon, 19 Dec 2011 10:04:02 +0000 This 90-minute training will assist you in understanding the complex interaction between FMLA and ADA (AA) as it relates to intermittent leave requests with an underlying accommodation. http://www.calfeed.com/events/1512-When-FMLA-ends-and-ADA-begins.-The-FMLA/ADA-Crossover:-Coordination-Management-and-Compliance-Strategies http://www.calfeed.com/1512 Fri, 27 Jan 2012 07:41:48 +0000 This training on hiring and managing CROs or AROs will show how you can ensure that you choose the right CRO/ARO based on the phase of the trial, the therapeutic area and the countries that the trials will be conducted. http://www.calfeed.com/events/1496-CRO-or-ARO:-How-to-Hire-and-Manage-One http://www.calfeed.com/1496 Fri, 27 Jan 2012 06:48:21 +0000 This 90-minute cleanroom contamination control training will review the common mistakes that people make in cleanrooms that lead to contamination, show how to develop a successful contamination control program and discuss ways to improve your facility's design and maintenance. http://www.calfeed.com/events/1498-Environmental-Monitoring-and-Contamination-Control-Plan http://www.calfeed.com/1498 Fri, 27 Jan 2012 06:57:01 +0000 This training will show how you can handle customer complaints in compliance with FDA and ISO Regulations. We will discuss the best ways to document customer feedback, what constitutes a complaint, what do with "non-complaint" feedback, and how to include complaint trending into your firm’s CAPA program. http://www.calfeed.com/events/1422-Complaint-Handling-in-Compliance-with-FDA-and-ISO-Regulations http://www.calfeed.com/1422 Wed, 14 Dec 2011 10:46:35 +0000 This webinar will provide you tools and processes to verify a candidate’s qualifications in experience, education, character and work ethics. It will cover legal guidelines in doing reference and background checks. http://www.calfeed.com/events/1442-Conducting-Reference-Checks-Background-Checks-and-Alcohol-and-Drug-Testing http://www.calfeed.com/1442 Thu, 15 Dec 2011 06:25:53 +0000 The webinar will discuss the do’s and don’ts for using social media in marketing FDA-regulated products. Common issues, misconceptions, perceptions, and possible solutions will be discussed. http://www.calfeed.com/events/1499-Social-Media-and-Marketing-FDA-Regulated-Products http://www.calfeed.com/1499 Fri, 27 Jan 2012 06:58:56 +0000 This 3-hr virtual seminar on HIPAA Privacy and Security Audits and Enforcement will cover HIPAA Privacy, Security, and Breach Notification regulations (and the recent changes to them) and how they will be audited. http://www.calfeed.com/events/1403-HIPAA-Privacy-and-Security-Audits-and-Enforcement:-What-the-new-program-is-about-how-it-works-and-what-happens-if-a-violation-is-found http://www.calfeed.com/1403 Tue, 13 Dec 2011 12:32:34 +0000 This 3-hr virtual seminar - OSHA Asbestos and Mold Awareness - will cover OSHA's regulations on Asbestos and specific guidelines and general regulations on Mold. http://www.calfeed.com/events/1449-OSHA-Asbestos-and-Mold-Awareness:-All-in-One-Session http://www.calfeed.com/1449 Thu, 15 Dec 2011 06:51:51 +0000 This 90-minute webinar on Advanced Methods of Root Causes Analysis, for medical device companies, will cover principles and methods of Root Cause Analysis (RCA) and review proven techniques for ISO 14971 Risk Reduction based on RCA. http://www.calfeed.com/events/1504-Advanced-Methods-of-Root-Causes-Analysis-for-ISO-14971-Risk-Reduction http://www.calfeed.com/1504 Fri, 27 Jan 2012 07:15:57 +0000 This 90-minute training on Online Recruiting will provide a comprehensive review of how to avoid intentional and unintentional discrimination when using social media tools for recruiting.

Why Should You Attend:

There is a wealth of personal information available in a social media profile. http://www.calfeed.com/events/1511-Avoiding-Discrimination-When-Recruiting-With-Social-Media-Tools http://www.calfeed.com/1511 Fri, 27 Jan 2012 07:39:35 +0000 This webinar will examine in detail the U.S. FDA and EU MDD requirements for DHFs, DMRs, DHRs, and TF/DDs -- their commonalities and their differences. http://www.calfeed.com/events/1423-Design-History-Files-Device-Master-Records-Device-History-Records-and-Technical-Files-/-Design-Dossiers----Differences-and-Similarities http://www.calfeed.com/1423 Wed, 14 Dec 2011 10:48:20 +0000 This 90-minute webinar will cover the basic principles of pharmacogenomics and pharmacogenetics and will discuss in detail the steps behind implementing a clinical pharmacotenomic testing service. http://www.calfeed.com/events/1497-Implementation-of-Pharmacogenomics-into-the-Routine-Clinical-Laboratory http://www.calfeed.com/1497 Fri, 27 Jan 2012 06:54:14 +0000 This is one of Xcelience's scientific seminars for 2012. Xcelience is a contract research organization that provides a number of pharmaceutical services, including analytical method development. The guest speaker for this event is Paul Thomas. http://www.calfeed.com/events/1542-What-to-Expect-From-a-QP-Audit http://www.calfeed.com/1542 Fri, 03 Feb 2012 00:35:55 +0000 This Japan Regulatory and Clinical Trial Requirements training will cover Japan Regulatory Agency Structure and Responsibilities, its review process for decision-making and approval, requirements for clinical trials in Japan and the procedures for conducting clinical studies in the country and reporting them.

Why Should You Attend:

This 6 hour virtual seminar will help you gain a comprehensive understanding of the Regulatory Structure, Clinical Trial Requirements and the Conduct of Running Clinical Research in Japan. http://www.calfeed.com/events/1353-Navigating-the-Japan-Regulatory-and-Clinical-Trial-Environment;-Conducting-Clinical-Studies-in-Japan http://www.calfeed.com/1353 Fri, 11 Nov 2011 10:33:07 +0000 This Bioassays webinar will systematically outline the steps needed to successfully transfer validated biological assays between GMP/GLP labs and also acquire non-validated assays for GMP/GLP development. http://www.calfeed.com/events/1410-Accelerating-Bioassay-Transfer-in-a-GMP-Environment http://www.calfeed.com/1410 Wed, 14 Dec 2011 10:02:16 +0000 This webinar will cover the basics of design controls for medical devices, and provide recommendations for implementation of a compliant design control system. http://www.calfeed.com/events/1424-Understanding-Design-Controls-for-Medical-Devices http://www.calfeed.com/1424 Wed, 14 Dec 2011 10:50:32 +0000 In this sterility assurance documentation webinar, you will learn specifically what information is required in sterility assurance documentation for injectable drug products and how to present it in CTD format. http://www.calfeed.com/events/1434-Submission-Documentation-for-Sterilization-Process-Validation---A-Comprehensive-View-of-Content-for-an-Approvable-CMC-Section http://www.calfeed.com/1434 Wed, 14 Dec 2011 12:22:02 +0000 This 90-minute training will provide an introduction to FDA’s rules governing pet food product development and formulation, manufacturing, labeling; and marketing and promotion. http://www.calfeed.com/events/1510-The-Regulation-of-Pet-Food-in-the-United-States http://www.calfeed.com/1510 Fri, 27 Jan 2012 07:31:10 +0000 This 6-hr virtual seminar will review analytical procedures used in assessing quality, safety and efficacy of drug products. It will cover the ICH and USP guidelines for procedure validation and help you ensure robust validation of analytical procedures for drug substances and products.

Why Should You Attend:

This 6-hr training will examine the analytical tools used throughout a drug product life cycle. There is a broad range of assays and techniques used to measure the quality, safety and efficacy of a drug substance or a drug product. http://www.calfeed.com/events/1525-Validation-of-Analytical-Procedures-for-Use-in-the-Pharmaceutical-Industry http://www.calfeed.com/1525 Mon, 30 Jan 2012 08:14:30 +0000 This CLIA Webinar training will feature an in-depth look at CLIA Waived Testing. It will present the rules and regulations as well as the pros and cons of testing using Waived methods.

Why Should You Attend:
Waived testing is an exciting way to leap into the world of laboratory testing. With over a hundred tests to choose from, every speciality can find testing that will benefit the patients. http://www.calfeed.com/events/1386-Leaping-into-Lab:-Everything-about-Waived-Testing http://www.calfeed.com/1386 Fri, 11 Nov 2011 12:07:16 +0000 This HR Audit training will help you assess your organization's risks and discusses the use of HR audits as a continuous audit process that strengths internal controls, provides assurance of compliance, and evaluates outcomes. http://www.calfeed.com/events/1443-What’s-New-in-HR-Auditing http://www.calfeed.com/1443 Thu, 15 Dec 2011 06:29:18 +0000 This 90-minute will help exporters and importers understand the three international trade finance methods of payment; to include Letters of Credit, Documentary Collections and Open Account; and their variations.

Companies that export and import products can use Documentary Letters of Credit, Documentary Collections or Open Accounts to purchase and sell goods globally. Understanding the proper application and documents involved will assist in the reliable payment for goods sold. http://www.calfeed.com/events/1534-International-Trade-Finance-Payment-Methods http://www.calfeed.com/1534 Mon, 30 Jan 2012 08:43:17 +0000 This 3-hr virtual seminar on child support regulations will focus on federal and state requirements to compliantly and effectively handle child support withholding orders.

Why Should You Attend:

Dealing with child support withholding orders can cause some of the most stressful and emotional situations that can be encountered in payroll. http://www.calfeed.com/events/1513-Child-Support:-Complete-and-In-Depth http://www.calfeed.com/1513 Fri, 27 Jan 2012 07:44:13 +0000 This webinar will help you understand the EU data transfer regime and the significant differences within the EU member states in relation to the way in which data transfers are permitted from the EU to other countries.

Why Should You Attend:

The EU laws on data sharing and data transfer were drafted in an era when data moved slowly and in small quantities. http://www.calfeed.com/events/1520-Global-Data-Transfer-Solutions-–-Complying-with-EU-Laws-&-Regulations http://www.calfeed.com/1520 Mon, 30 Jan 2012 07:58:56 +0000 This 90-minute OSHA Recordkeeping training class will incorporate the lessons learned from OSHA’s recent Interpretation Letters into the existing OSHA recordkeeping analysis as well as OSHA’s current Frequently Asked Questions.

Why Should You Attend:

OSHA injury and illness recordkeeping compliance is a point of emphasis for OSHA, and the recordkeeping regulations are frequently cited by the Agency. http://www.calfeed.com/events/1527-OSHA-Recordkeeping:-Recent-Recordkeeping-Interpretations http://www.calfeed.com/1527 Mon, 30 Jan 2012 08:24:08 +0000 This webinar on Defending Against OFAC Investigations is designed to teach participants to successfully navigate the OFAC enforcement process and reduce any OFAC penalties. http://www.calfeed.com/events/1453-Defending-Against-an-OFAC-Investigation http://www.calfeed.com/1453 Thu, 15 Dec 2011 07:23:45 +0000 This 2-hr Dissolution Instrument Qualification webinar will discuss recent FDA requirements for dissolution instrument qualification and provide practical suggestions to avoid pitfalls in performance of the tests, minimize Performance Verification Test and product failures. http://www.calfeed.com/events/1508-Dissolution-Instrument-Qualification-to-Meet-Requirements-and-Minimize-Product-OOS-Dissolution-Results http://www.calfeed.com/1508 Fri, 27 Jan 2012 07:24:11 +0000 This 90-minute webinar will provide an overview of regulatory management for clinical trials. It will discuss key regulatory aspects of a clinical project such as clinical protocol management, IRB management, safety reporting, rules for recruitment programs, seeking advice from FDA, trial master files, and training requirements. http://www.calfeed.com/events/1538-Regulatory-Perspectives-of-Clinical-Project-Management:-Meeting-FDA-Requirements-for-Clinical-Trials http://www.calfeed.com/1538 Tue, 31 Jan 2012 11:40:09 +0000 Many citations by FDA and notified bodies include findings with respect to insufficient information in the Design History File, not following the procedures to make the device as established in the DMR, and incomplete or inaccurate production data of incoming,in-process and finished products. Is your company able to access all relevant documents detailing the design of your device? Is your DMR accurate and is it being followed? Can the operators access your DMR? Are you recording and documenting all your production and testing data and maintaining them in the DHR?


Areas Covered in the Session:


- DMR and outsourced design/production

- DMR and OEM relationships

- Controlling and maintaining DMR

- Device History Record (DHR)

- Definition

- Contents

- Using DHR data for tracking and trending

- DHR and outsourced design/production

- DHR and OEM relationships

- Technical File (TF)

- Definition

- Contents

- TF and outsourced design/production

- TF and OEM relationship

- Design/process changes and DHF, DMR, DHR, and TF



Who will benefit:



This Webinar is designed for people involved in document preparation and maintenance, and those who have involvement with documentation. This typically includes:



Quality Managers/Engineers

Production/Process Managers/Engineers

Manufacturing Managers/Engineers

QA and QC managers, inspectors, supervisors and personnel

Documentation Specialists
Supplier Quality Managers/Engineers


About Speaker

Jeff Kasoff, RAC, is the Director of Quality at Byrne Medical, a leading manufacturer of endoscopy products. In this position, Jeff is responsible for supplier management, during which he oversees supplier management, CAPA, and document control. Prior to this, Jeff spent 13 years at Life-Tech as the Director of Regulatory Affairs, where he was responsible for regulatory compliance of all aspects of the quality system. Jeff received his regulatory affairs certification in 1996. http://www.calfeed.com/events/1474-Design-History-File-(DHF)-Device-Master-Record-(DMR)-Device-History-Record-(DHR)-and-Technical-File-(TF)---Regulatory-Documents-Explained http://www.calfeed.com/1474 Fri, 13 Jan 2012 04:33:47 +0000 This 90-minute training will discuss the FDA's QSR requirements for a Device Master Record (DMR) and how you can use it to build your Device History Record (DHR). http://www.calfeed.com/events/1425-DMR-&-DHR---What-Is-Really-Required http://www.calfeed.com/1425 Wed, 14 Dec 2011 10:55:31 +0000 This 90-minute webinar will help you identify the challenges in Phase I and FIM studies and present solutions on how to overcome these challenges.

Why Should You Attend:

As need for more aggressive drug development that still ensures the safety of the subjects and the drug itself becomes more and more important, the challenges of those individuals responsible for the Phase I activities increase exponentially. http://www.calfeed.com/events/1539-Solutions-to-the-Challenges-of-Phase-I-and-FIM-Studies-in-Today’s-World http://www.calfeed.com/1539 Tue, 31 Jan 2012 11:42:09 +0000 This 6-hr virtual seminar will focus on the regulatory compliance requirements and procedures for conducting Clinical Trials on Pharmaceutical Products in South Korea. http://www.calfeed.com/events/1500-South-Korea:-Navigating-the-Regulatory-and-Clinical-Trial-Environment http://www.calfeed.com/1500 Fri, 27 Jan 2012 07:05:38 +0000 In this 90-minute training you will learn more about SSAE 16 (formally known as SAS 70), SOC 1, SOC 2 and SOC 3 reporting, how to choose the right report for your organization and how to get ready for the attestation.

Why Should You Attend:

Companies are familiar with SAS70 reports, which were prepared following the AICPAs Statement of Auditing Standards No 70. http://www.calfeed.com/events/1521-SSAE-16-(formally-known-as-SAS70)-SOC1-to-SOC-3-Reporting-Demystified http://www.calfeed.com/1521 Mon, 30 Jan 2012 08:01:02 +0000 This 3-hr virtual seminar on HIPAA Security Policies and Procedures will show how you can comply with the extensive requirements for policies and procedures in the HIPAA security regulation. http://www.calfeed.com/events/1404-HIPAA-Security-Policies-and-Procedures:-New-finalized-regulations-bring-new-obligations http://www.calfeed.com/1404 Tue, 13 Dec 2011 12:34:14 +0000 This webinar on Workplace Dress Codes will discuss your reasons and rights as an employer to establish a dress code in your workplace and how to develop and adopt one that complements your business. http://www.calfeed.com/events/1444-Dress-Codes-for-the-Workplace---Legally-Compliant-Policies-and-Guidelines http://www.calfeed.com/1444 Thu, 15 Dec 2011 06:34:54 +0000 This 3-hr virtual seminar on Project Management in Human Resources will focus on key project management skills for the HR professional. You will learn proven, successful techniques for detailed, systematic, team-involved planning and effective implementation.

Why Should You Attend:

You as an HR leader play a major role in shaping your company’s strategy as well as ensuring that the strategy is carried out as planned. http://www.calfeed.com/events/1515-Project-Management-in-Human-Resources http://www.calfeed.com/1515 Fri, 27 Jan 2012 07:48:02 +0000 Overview: This training course is designed to give pharmaceutical and biologic companies operating in the U.S. and EU an understanding of product safety and regulatory compliance. The course will include case studies of adverse events to illustrate the decision-making process and reasoning needed behind when and how to properly report incidents to regulatory authorities.
Product safety makes headlines every day - and the impact on a company’s image, consumer confidence, and Wall Street’s opinion is profound. While good safety data has historically been a prerequisite for product approval, recent media attention has intensified public and Congressional scrutiny and resulted in regulations such as the FDA Amendment Act and its strengthened requirements for monitoring post-marketing safety.
Agenda:
• Overview of Pharmacovigilance
• Assessing Adverse Event Cases
• Reporting Adverse Events
• Global Regulatory Requirements
• Inspections and Audits
• Pharmacovigilance Best Practices
• Preparing for an Inspection
• Case Studies with Real-Life Inspection Findings
• Background to Signal Detection
• Signaling Exercises
• Data Mining Exercises
• Pharmacovigilance and Risk Management Process
Who will benefit:
• Drug safety and Pharmacovigilance
• Regulatory affairs
• Clinical development
• Executives (including C-Level) with any Legal responsibility for drug safety
• Clinical safety staff
• Pharmacovigilance specialists
• Regulatory affairs professionals
• Quality management specialists
• Management involved in clinical oversight
• Pharmacovigilance
• Pharmacoepidemiology
• Regulatory affairs


Steve Jolley, Principal, SJ Pharma Consulting
Steve Jolley is a subject matter expert in all areas of global safety compliance and signal detection, and is a frequent speaker at leading industry events including DIA and MHRA. He has 25 Years’ experience in drug safety & Pharmacovigilance and has worked with over 50 clients in the US, Europe and Japan. He holds degrees in mathematics and computer science from Cambridge University, England. Steve is a featured speaker with FDA at DIA conferences and webinars on auditing, signaling and data mining. Steve began his career in the pharmaceutical industry in 1985 when he founded DLB Systems, a supplier of computer systems for clinical trials and adverse event reporting to many of the leading life science companies worldwide.

DATE AND VENUE: Venue
March 5th, 6th and 7th, 2012
at Mumbai, INDIA
Conference Timings: 9:00 am - 6:00 pm http://www.calfeed.com/events/1543-USFDA-&-EU-Essentials-of-Drug-Safety-and-Pharmacovigilance---India-Seminar-2012-at-Mumbai http://www.calfeed.com/1543 Fri, 03 Feb 2012 12:43:33 +0000 This webinar will show how you can use failure data to predict expected future failures, proactively drive quality and reliability improvement and react quickly to emerging issues.

Why Should You Attend:

Manufacturers design and develop products based on an expected product lifetime. Many manufacturers conduct extensive reliability testing to minimize the risk that products will fail prematurely. http://www.calfeed.com/events/1532-Predicting-Warranty-Expense-Using-Reliability-Analysis-Methods http://www.calfeed.com/1532 Mon, 30 Jan 2012 08:38:55 +0000 It is well known that document control is a critical requirement for FDA-regulated companies. However, document control can be a time- and paper-consuming process, in which even the simplest of changes requires an inordinate amount of time spent in the preparation, submission, distribution, and implementation of change requests, document modifications, document review meetings, document approvals, and document placement. The best document control systems are those that are fast and effective. This presentation will review the QSR and ISO requirements for document control, and provide a streamlined process - Many companies can spend MUCH LESS preparing MANY FEWER documents, and still be in compliance with the regulations; is yours one of these?





Areas Covered in the Session:



- QSR and ISO 13485 requirements for document control


- Description of typical document control system in use


- Streamlined document control process


- Paper-free document review


- Immediate document distribution



Who will benefit:


This webinar will provide valuable assistance to all regulated companies that are interested in learning about the requirements for a document control system, and spending less time on its implementation and performance. The employees who will benefit include:


Executive Management

Document Control Management

Document Control Clerks

Consultants

Quality system auditors





About Speaker

Jeff Kasoff, RAC, is the Director of Quality at Byrne Medical, a leading manufacturer of endoscopy products. In this position, Jeff is responsible for supplier management, during which he oversees supplier management, CAPA, and document control. Prior to this, Jeff spent 13 years at Life-Tech as the Director of Regulatory Affairs, where he was responsible for regulatory compliance of all aspects of the quality system. Jeff received his regulatory affairs certification in 1996. http://www.calfeed.com/events/1475-Document-Approval-Control-and-Distribution:-How-to-Develop-a-Compliant-Cost-Effective-System http://www.calfeed.com/1475 Fri, 13 Jan 2012 04:35:11 +0000 This Software Verification and Validation training will help you understand and recognize the most common software V&V failings and their fixes. You will learn how to develop and use a repeatable software V&V template for all software validation projects. http://www.calfeed.com/events/1501-Software-Verification-and-Validation-Planning-and-Implementation http://www.calfeed.com/1501 Fri, 27 Jan 2012 07:08:23 +0000 Course Description:

This is a practical and interactive seminar for those participants with some export & logistics experience and will serve as a refresher for more experienced industry leaders.

Register today. Attendees who register before Jan 31, 2012, will receive a complimentary copy of Trade Compliance Awareness CD from the speakers.

During this two day course you will master the basics elements of U.S. export controls and policies required to mitigate liability due to inadvertent U.S. export violations. You will learn how to interpret the export regulations and elements of an export control, how to file the Electronic Export Information (EEI) and create a bulletproof Export Management & Compliance Program. In addition, you will understand the requirements to file international and domestic cargo claims for loss and damage against service providers in order to obtain timely recoveries for your company. Attendees will have opportunity to engage in practical exercises and receive complimentary training material.

Learning Objectives:

Upon course completion participants will learn:

The basics of the Export Administration Regulations (EAR)
How to classify your product for international shipping
What are the basic export documents and how to prepare them
When you are required to file an EEI or apply for an export license
Basic export tools that will reduce risk of export fines and penalties
The legal requirements for filing a cargo claim
How to file an effective cargo claim against your service provider and bring more value to your company

Who will benefit:

This course benefits anyone who has responsibility for exporting or shipping at any global organization that is involved in international trade.

Trade Compliance & Export Managers
Logistics & Supply Chain Managers
Shipping Managers
Legal
Sales
Internal Audit

Meet Your Instructor

Jo-Anne Daniels, is a Licensed Customs Broker for 25 years. Ms Daniels is the President of Trade Resources & Associates, a consulting firm providing international trade services to corporations and has been responsible for global trade compliance for multinational corporations, such as, Aviza Technology, Inc., Solectron Corporation, Applied Materials, and Siemens. She specializes in Customs, Commerce, and ITAR compliance assessments, executive awareness training, export and import classification guidance, supply chain security reviews and C-TPAT certification. She has been a featured guest speaker for trade associations, logistic organizations, a guest lecturer at Golden Gate College. Ms.Daniels is a published writer, trainer, and President of the Professional Association of Exporters & Importers.

Johanne M. Dictor has over 15 years of experience in the cargo industry. Johanne's experience ranges from domestic to international and includes air, ocean, and surface transportation matters for cargo airlines, insurance companies, freight forwarders and shippers. Johanne has worked with airlines and freight forwarders to develop their Risk Management Claims offices and to establish appropriate policies, procedures and standards for their cargo claims departments and implementation of cargo claim computerized technology. Johanne has also provided education and training in the area of cargo subrogation recoveries on claims with insurance companies and major cargo airlines. http://www.calfeed.com/events/1319-Best-Practices-for-Managing-Export-Control-&-Cargo-Claims http://www.calfeed.com/1319 Thu, 10 Nov 2011 09:50:40 +0000 This Immunogenicity risk training Webinar will help you understand immunogenicity and analyzing risk factors to strategically develop biopharmaceuticals. http://www.calfeed.com/events/1411-Managing-Immunogenicity-Risk-in-Biopharmaceuticals http://www.calfeed.com/1411 Wed, 14 Dec 2011 10:06:11 +0000 This 90-minute training on managing discrimination litigation risks will provide a comprehensive primer on reviewing compensation systems for internal equity and discuss why, in light of recent legal and regulatory changes, employers should be performing compensation reviews. http://www.calfeed.com/events/1514-Managing-the-Risk-of-Discrimination-Litigation-with-a-Compensation-Review http://www.calfeed.com/1514 Fri, 27 Jan 2012 07:45:57 +0000 Course Description:

"Application of CAPA to the Device Sterilization Process" - This course is certified by RAPS. Attendees are eligible for 12 RAC points on completion of the Seminar.


Do you use a Contract Sterilizer for your medical device sterilization? Are you not an expert in industrial sterilization? If you answered “yes” to either of these questions, this seminar is a must for you and your team members.

The FDA and your Notified Body will look to you, the medical device manufacturer, for the answers to deficiencies in the sterilization process whether sterilization is performed at your location or at a contract sterilizer.

In this seminar you will be provided a basic understanding of radiation and EO sterilization processes and validation methods associated with both methods. Typical and non-typical sterilization deficiencies will be reviewed and insight provided on the investigation needed to provide root cause to the deficiency and lead to effective CAPA. CAPA will also be reviewed in detail to provide an understanding of what CAPA is, the regulations and standards involved, and when to apply CAPA. A hands on workshop is held at the end of the sessions where the attendee will be provided “real case” deficiencies and will apply information received during the seminar, ensuring a full understanding of applying CAPA for your sterilization processes.

Who will benefit

This course benefits anyone involved in ensuring quality for medical devices and is ideal for quality and engineering professionals working in the medical device sector.

QA personnel
CAPA team members
SA personnel
Quality Engineers
Operations Managers

Meet Your Instructors

Ms. Foster began her medical device career at Sterigenics International in 1989. Throughout her tenure, Ms. Foster has held various quality assurance positions at both the facility and Corporate levels where she served as Sterigenics Vice President of Quality Assurance from 1997 – 2004 and as Vice President SteriPro Labs & Consulting from 2004-2011. Most recently she has started her own firm, Adiuvo QS & SA Consulting and has a joint relationship with Blue Skies LLC.

Ms. Foster is an Executive Committee Member of the AAMI Sterilization Standards Board (invitation only), a member of the AAMI Sterilization Standards Committee (invitation only), serves as Co-Chair and ISO delegate to AAMI/ISO/TC 198/WG2 Radiation Sterilization Working Group, has served as co-chair for the AAMI Radiation Process Control Task Group, which developed TIR 29, Guide for Process Control in Radiation Sterilization, and is also an active member of several other AAMI Sterilization Working groups. Ms. Foster has been a presenter at numerous industry and FDA training seminars throughout the United States. She holds a Bachelor of Science in Food and Nutrition from Mississippi University for Women and a Masters of Science in Food Technology from Mississippi State University. Ms. Foster's areas of expertise include sterilization, sterilization validation, regulatory compliance, Quality System Regulation, quality systems management, CAPA, and FEMA.

Ms. Celeste Amlen is an experienced Quality Executive Professional with over 20 years experience in the Medical Device and In-vitro Diagnostics Industries.

A proven Quality Assurance leader with international work experience from several Fortune 500 companies. A successful track record in continuously improving performing Quality Assurance organizations. A catalyst for turning around ailing organizations through the implementation of new organizational structures, system implementations as well as execution of business process transformation projects. Extensive experience working in a fast paced, high-energy work environment on high visibility projects, with the last eleven years dedicated to Quality Systems and Project Management in the Medical Device and In-vitro Diagnostics industry. http://www.calfeed.com/events/1322-Application-of-CAPA-to-the-Device-Sterilization-Process http://www.calfeed.com/1322 Thu, 10 Nov 2011 09:58:34 +0000 This Validation of Bioanalytical Methods and Procedures training will demonstrate how to validate bioanalytical methods and procedures, in analytical laboratories, for FDA compliance.

Why Should You Attend:

Analyzing biological fluids is one on the most difficult tasks in analytical laboratories. Most challenging are interferences from matrices and decomposition products combined with low concentrations of analytes. http://www.calfeed.com/events/1526-Validation-of-Bioanalytical-Methods-and-Procedures-for-FDA-Compliance http://www.calfeed.com/1526 Mon, 30 Jan 2012 08:18:22 +0000 This webinar will help you understand the significant differences within the EU member states in relation to the way in which ethical/whistleblower hotlines can be implemented within a multinational organization.

Why Should You Attend:

The increase in laws that require businesses to encourage employees to report suspected breaches of laws and regulations and to comply with business codes of conduct mean that ethical reporting and whistleblower hotlines are a business norm. http://www.calfeed.com/events/1522-Ethical-Hotlines-Whistleblowers-and-Compliance-with-the-EU-Data-Privacy-Laws-&-Regulations http://www.calfeed.com/1522 Mon, 30 Jan 2012 08:04:03 +0000 This 6 hour virtual seminar will help you gain a comprehensive understanding of ICH GMPs and the nuances and differences between requirements in the US, EU and Japan. It will prepare you for regulatory inspections in these countries.

Why Should You Attend:

This full-day ICH GMP training course will provide your company the opportunity for a comprehensive understanding of ICH GMP and the nuances and differences between the three main ICH triumvirate regions (U.S. EU and Japan). http://www.calfeed.com/events/1332-US-EU-and-Japan-GMP-Requirements:-Practical-ICH-Area-Differences-Healthcare-Authority-Inspection-Focus http://www.calfeed.com/1332 Fri, 11 Nov 2011 08:39:36 +0000 This OFAC Licensing webinar introduces the licensing programs of the United States Department of the Treasury’s Office of Foreign Assets Control (OFAC), which authorizes business transactions despite the existence of Embargoes and Sanctions. http://www.calfeed.com/events/1454-Doing-Business-Despite-Embargoes-and-Sanctions:-OFAC-Licensing http://www.calfeed.com/1454 Thu, 15 Dec 2011 07:25:56 +0000 This 90-minute webinar on Disinfection and Cleanroom Cleaning will cover effective ways to rotate disinfectants, most current industry methods for applying disinfectants and effective methods for controlling residues. http://www.calfeed.com/events/1502-Understanding-Disinfection-and-Cleanroom-Cleaning-in-a-FDA-Regulated-Environment http://www.calfeed.com/1502 Fri, 27 Jan 2012 07:10:53 +0000 This 90-minute webinar will help exporters and importers understand Letter of Credit terms and conditions that go into structuring a transaction for successful payment and receipt of goods.

Companies that export and import products can use Documentary Letters of Credit to purchase and sell goods globally. Letters of Credit are the primary instruments for assuring payment of goods sold internationally. http://www.calfeed.com/events/1535-Letter-of-Credit-Terms-and-Conditions http://www.calfeed.com/1535 Mon, 30 Jan 2012 08:45:47 +0000 This OSHA inspection webinar will cover aspects of an OSHA inspection from how establishments are targeted, how to limit the scope of an inspection or investigation, how not to self-incriminate, and when and how to appeal.

Why Should You Attend:

An OSHA inspection can be a costly and disruptive experience for any employer, especially if that employer has not dealt with the Agency, does not have an in-house safety professional or attorney. http://www.calfeed.com/events/1528-OSHA-Inspections-–-Avoiding-the-10-Most-Common-Mistakes http://www.calfeed.com/1528 Mon, 30 Jan 2012 08:26:31 +0000 Over half of enterprises were audited by their software vendor in 2010, according to Gartner. Industry experts discuss current trends, audit triggers, and how to manage a software audit. Speakers: TBD http://www.calfeed.com/events/1540-Software-Vendor-Audits:-Triggers-Trends-Threats-and-Prevention http://www.calfeed.com/1540 Tue, 31 Jan 2012 21:39:53 +0000 Why Should You Attend:


This course specifically focuses on the overall regulatory compliance requirements and procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products in Latin America. The primary countries covered will include: Argentina, Brazil and Mexico. Other countries such asChile, Costa Rica, Dominican Republic, Panama, Peru and Venezuela will be discussed. The course will cover topics relating to pre-clinical and clinical requirements, as well as, addressing the structure of the regulatory agencies in Latin America. Content will include descriptions of the methods by which regulators in the corresponding agencies process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products.


The current regulatory climate in Latin America is discussed in detail and several examples will be provided to illustrate effective compliance procedures and techniques. Common issues that have caused difficulties for Life Sciences firms in the region are outlined. Course content will explain how Latin America interacts with and utilizes ICH standards and how they relate with other national regulatory agencies. Additionally, participants will learn how personnel can best address the conflicts, which arise and the best course for resolution.


Agenda: (All time in EST)


1:00 – 2:15 pm Course Delivery

2:15 – 2:30 pm Q&A Session


Areas Covered in the Seminar:


• Glossary of Terms.

• Defining the Opportunity.

• Country Facts: Argentina, Brazil, Mexico.

• Latin America's Regulatory Structure for the Life Science Product Industries

• Mercosur - Southern Common Market.

• Beginning Your Company Involvement in Latin America: Examples of Country Requirements.

• Registration / Required Country Licenses.

• Common Fees.



• Overview of the Rules Governing Medicinal Products & Medical Devices.

o Select Examples of:Clinical Trials, GCP, GMP, Specials, Marketing Authorizations, Product Classifications, Scientific Advice, Generics Pricing, Patents, Labeling, SPC, Variations, Manufacturing Licenses, Renewals, Pharmacovigilance, Orphan Drugs.


• Marketing Authorization Processes - Filings & Registrations.

o Drug vs. Medical Device vs. Biologic vs. Combination Product.


• Drug Master File (DMF) Use in Latin America Registrations.

• Use of Expert Reports.



• Processing Variations on Licensed Products.

o Variations: Changes to Marketed Products.

o Types of Variations.

o Dossier Maintenance Expectations.

o Changes Concerning Manufacturing Aspects (Product & Process).


• Labeling & Packaging Leaflet Requirements.

• Orphan Drugs / Rare Diseases.



• Comparing and Contrasting Latin American Procedures vs. the U.S. FDA.

o Comparison of Processes.

o Agency Interactions.

o Accepted Practices.


• How and When to Influence the Regulatory Process.

o Accepted Country Practices.

o Effective Monitoring Activity.

o Association vs. Individual Company Involvement & Intervention.


• The Regulatory Negotiation Process.

o Effective Approaches.

o The Do's and Don'ts of Regulatory Involvement.


• How to Use Regulations / Regulatory Contacts to Your Advantage.

o Check-in Procedure.

o Agency Interactions.

o Business Impact Within and Outside Latin America.

o Professionalism in Regulatory Lobbying.


• Resources / Helpful Websites


Who Will Benefit:


This course will be beneficial to:


• Regulatory personnel whose responsibilities require knowledge of the Latin American regulatory environment

• Administrative staff responsible for ensuring compliance with regulatory filings and overall regulatory compliance requirements

• QA / QC Personnel

• Global Supply Chain personnel

• Clinical / Pharma & Device personnel

• Manufacturing personnel

• Global Business Development personnel

• Any sales or general management employee requiring an understanding of how regulations and compliance issues impact the organization





About Speaker

Robert J. Russell, is President and CEO of RJR Consulting, Inc, a leading Global Regulatory Consulting firm focusing on assisting the Life Science Industry. Prior to founding the firm in 2000, Mr. Russell had over 27 years of experience in CMC, Global Business Development and Regulatory Compliance for pharmaceuticals, biologics, medical devices and combination products. The company has an office in Brussels, Belgium where they interact with the European Commission and the Competent Authorities across the EU. Country establishment, marketing authorizations, variations and license renewals are core competencies of the course director. Mr. Russell has received a B.S. and M.S.in Chemistry. http://www.calfeed.com/events/1476-Latin-America:-Regulatory-Compliance-Requirements-for-Life-Science-Products-(Focus:-Brazil-Mexico-Argentina) http://www.calfeed.com/1476 Fri, 13 Jan 2012 04:36:28 +0000 This Project Management training for FDA Regulated Companies will show how you can meet key FDA and EU MDD regulatory requirements for the project you manage. http://www.calfeed.com/events/1505-Project-Management-To-Meet-CGMP-Requirements http://www.calfeed.com/1505 Fri, 27 Jan 2012 07:18:17 +0000 This webinar teaches how to perform risk assessment in order to reduce time for software testing. As part of the 10-step risk-based approach to computer system validation, the hazard analysis technique uses fill-in-the-blank templates. Ensure compliance with QA, FDA, and clients. Learn real life examples that make application of the technique understandable in the context of any validation project. As part of the workshop, perform your own hazard analysis so you can apply what you learn to what you do.



It is recommended to take the COTS Software Validation webinar as a prerequisit.





Learning Objectives:


How to use the risk-based approach to reduce validation time and lower costs.
Avoid 483s and Warning Letters.
Step-by-step instructions for performing and documenting a hazard analysis.
Interactive real life examples.
How to document the risk assessment using a template
Reduce testing by writing test cases that trace to elements of risk management.
Perform your own hazard analysis during the workshop.



Who is the Target Audience:



IT
QA
QC
Laboratory staff
Managers
GMP, GCP, GLP professionals



About Speaker

Computer System Validation’s principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation. He is involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications. He has completed more than 206 mission critical laboratory, clinical, and manufacturing software implementation projects. His latest book is “Risk Based Software Validation - Ten easy Steps” (Davis Horwood International and PDA - www.pda.org, 2006) which provides fill-in-the-blank templates for completing a COTS software validation project. http://www.calfeed.com/events/1477-Risk-analysis-for-software-validation-step-by-step-instructions http://www.calfeed.com/1477 Fri, 13 Jan 2012 04:38:55 +0000 After long delays, a random HIPAA Compliance Audit program is finally getting under way; up to 150 covered entities will be audited in 2012, and being prepared in advance is essential.


Areas Covered in the Session:


• Fines and penalties for violations of the HIPAA regulations have been significantly increased and now include mandatory fines for willful negligence that begin at $10,000 minimum.


• HIPAA Audits have been few and far between in the past, but that's now changing - the HHS is now auditing HIPAA covered entities and business associates even if there have been no complaints or problems reported.


• Find out what HHS OCR is likely to ask you if you are selected for an audit, and what you'll have to have prepared already when they do.


• Find out what the rules are that you need to comply with and what policies you can adopt that can help you come into compliance.


• Learn how the HIPAA rules have changed and how you may need to change how you work to keep up with them.


• Learn how having a good compliance process can help you stay compliant more easily.


• Find out what you'll need to have documented to survive an audit and avoid fines.


• Find out what you'll need to think about to deal with future threats to the security of patient information.


Why should you attend:


• The US Department of Health and Human Services (HHS)has begun a program to meet requirements in the HITECH Act in the American Recovery and Reinvestment Act of 2009 (ARRA) for performing periodic audits of compliance with the HIPAA Privacy and Security Rules, and up to 150 random HIPAA compliance audits will be performed by the end of 2012. While in the past, audits had been performed only at entities that had had a compliant filed against them, the new rule calls for audits whether or not there is a complaint. This means that the HHS Office for Civil Rights (OCR) can show up at your door and ask to perform an audit on short notice, and your organization will need to be ready in less than ten business days.


• If your organization is not ready, the HIPAA rules have new, significantly higher fines, including mandatory minimum fines of $10,000 for willful neglect of compliance. All HIPAA entities need to be fully in compliance and prepared for an audit at any time, or risk the significant fines for non-compliance.


• In addition, HIPAA enforcement has taken on a new importance at HHS, as shown in multi-million dollar fines and even a one million dollar settlement for a breach of just 192 records. HHS OCR officials have publicly stated that enforcement is now a priority, and that means being ready for an audit is more important than ever. The "slap-on-the-wrist" days are over and fines and settlements are being levied, with more on the way -- don't let your organization be hit for an audit unprepared. And even postal inspectors are now using HIPAA to prosecute identity theft cases.


• By using an information security management process, those responsible for health information can develop the procedures and policies that can help prevent security problems, and help prepare the organization for any incidents, audits, or enforcement actions.


• If you don't take the proper steps to ensure your patients' health information is being protected according to the HIPAA Security and Privacy Rules, you can be hit with significant fines and penalties. With the increased HIPAA fines beginning at $10,000 in cases of willful neglect, providing good information security and being in compliance are more important than ever.


• In addition new enforcement is taking place related to the new HIPAA Breach Notification Rule – when a breach is reported, HHS inspectors can investigate to determine if a penalty is warranted.



Description of the topic:


• In this session we will discuss the HIPAA audit and enforcement regulations and processes, and how they apply to HIPAA covered entities and business associates, and the new random HIPAA compliance audit program in particular. We will explain the enforcement regulations and the recent changes that increase fines and create new penalty levels, including new penalties for willful neglect of compliance that begin at $10,000. We will discuss what information and documentation must be prepared in advance so that you can be ready for an audit any time. Sample information request forms and questions asked at prior audits will be presented.


• The session will also cover how to know if you may become the subject of an audit or enforcement action, and what you can do to help limit your exposure. We will discuss how most enforcement actions come about and what can be done to prevent incidents that lead to enforcement.


• The HIPAA Privacy, Security, and Breach Notification regulations (and the recent changes to them) and how they will be audited will be explained. Documentation requirements for compliance will be explored and a framework of security policies necessary for compliance will be presented. Meeting any set of information security requirements always involves conducting a thorough risk analysis to make sure you haven't overlooked any weaknesses. We'll discuss what's involved and how it is the cornerstone of your compliance efforts.


• The results of prior HHS audits (and their penalties) will be discussed, including recent actions involving multi-million dollar fines and settlments. A plan for attaining compliance will be presented. The steps to follow to prepare for an audit and respond to an audit request will be outlined. In addition, upcoming trends in information security risks will be discussed.


Who will benefit:


· Compliance director

· CEO

· CFO

· Privacy Officer

· Security Officer

· Information Systems Manager

· HIPAA Officer

· Chief Information Officer

· Health Information Manager

· Healthcare Counsel/lawyer

· Office Manager
Contracts Manager


About Speaker

Jim Sheldon-Dean is the founder and director of compliance services at Lewis Creek Systems, LLC, a Vermont-based consulting firm founded in 1982, providing information privacy and security regulatory compliance services to a variety of health care providers, businesses, universities, small and large hospitals, urban and rural mental health and social service agencies, health insurance plans, and health care business associates. He serves on the HIMSS Information Systems Security Workgroup, has co-chaired the Workgroup for Electronic Data Interchange Privacy and Security Workgroup, and is a recipient of the 2011 WEDI Award of Merit. He is a frequent speaker regarding HIPAA and information privacy and security compliance issues at seminars and conferences, including speaking engagements at AHIMA national and regional conventions and WEDI national conferences, and before the New York Metropolitan Chapter of the Healthcare Financial Management Association, Health Information Management Associations of Virginia, New York City, New York State, and Vermont, the Connecticut Hospital Association, and the Hospital and Health System Association of Pennsylvania. Sheldon-Dean has nearly 30 years of experience in policy analysis and implementation, business process analysis, information systems and software development. His experience includes leading the development of health care related Web sites; award-winning, best-selling commercial utility software; and mission-critical, fault-tolerant communications satellite control systems. In addition, he has eight years of experience doing hands-on medical work as a Vermont certified volunteer emergency medical technician. Sheldon-Dean received his B.S. degree, summa cum laude, from the University of Vermont and his master’s degree from the Massachusetts Institute of Technology. http://www.calfeed.com/events/1478-The-New-HIPAA-Random-Audit-Program:-How-to-be-prepared-and-avoid-penalties http://www.calfeed.com/1478 Fri, 13 Jan 2012 04:41:16 +0000 This 90-minute webinar on medical device quality assurance practices will review robust quality assurance principles and teach you techniques and lean methods to help you implement FDA Quality System Requirements. http://www.calfeed.com/events/1506-Elegant-Quality-Assurance-Practices-for-Device-Efficacy-and-Efficiency-Requirements http://www.calfeed.com/1506 Fri, 27 Jan 2012 07:20:03 +0000 his full-day virtual seminar on legal issues impacting HRM will provide a comprehensive overview of employment law, key legislation affecting your management decisions and your responsibility to understand and comply with it.

Why Should You Attend:

Federal, state, and local legislation is often cited by many emerging firms as one of the major barriers to growth. http://www.calfeed.com/events/1516-Legal-Issues-Impacting-Human-Resource-Management http://www.calfeed.com/1516 Fri, 27 Jan 2012 07:50:53 +0000 This 90-minute training on Adverse Impact Analysis will provide the right approach to preventing adverse impact and show how you can address its cause.

Why Should You Attend:

The idea of adverse impact has been around for nearly 50 years. Even though the concept is widely understood, employers are still faced with hundreds of discrimination lawsuits every year. http://www.calfeed.com/events/1517-The-HR-Practitioner’s-Guide-To-Adverse-Impact-Analysis http://www.calfeed.com/1517 Fri, 27 Jan 2012 07:52:44 +0000 Prior to introduction of a new device, or even a modified design for an existing device, a systematic process must be followed. This process must ensure that all requirements are met. A firm's design control process must meet all regulatory requirements, but at the same time not be so unwieldy as the present a barrier to timely market introduction. This webinar will cover the basics of design controls, and provide recommendations for implementation of a compliant design control system. Also discussed will be design control requirements for devices already in distribution. Documentation requirements for each design stage will be included as well.


Areas Covered in the Session:


- History of design control

- Design planning

- Design input/output

- Design reviews

- Design documentation

- Design transfer

- In-process design control



Who will benefit:



This webinar will provide valuable assistance to all companies that perform design activities. The employees who will benefit include:

R&D personnel and management

Process and Quality Engineers

QA management

Consultants

Quality system auditors



About Speaker

Jeff Kasoff, RAC, is the Director of Quality at Byrne Medical, a leading manufacturer of endoscopy products. In this position, Jeff is responsible for supplier management, during which he oversees supplier management, CAPA, and document control. Prior to this, Jeff spent 13 years at Life-Tech as the Director of Regulatory Affairs, where he was responsible for regulatory compliance of all aspects of the quality system. Jeff received his regulatory affairs certification in 1996. http://www.calfeed.com/events/1479-Understanding-Design-Controls-for-Medical-Devices http://www.calfeed.com/1479 Fri, 13 Jan 2012 04:42:42 +0000 Course Description
Day 1 - ISO 13485:2003 (includes comparison to ISO 9001:2008), Thursday, March 29, 2012

ISO 13485:2003 is a quality management system standard specially written for the medical device industry and is on the U S Food & Drug Administration (FDA) list of recognized consensus standards. ISO 13485 is also a critical system to assist with compliance to Canadian Medical Device regulations, European Medical Device (MDD) and IVD Directives, Japanese PAL requirements, and many other international regulatory requirements. Medical device firms certified to ISO 13485:2003 will find themselves very closely compliant with FDA’s Quality System Requirements under 21CFR 820.

This seminar includes an overview of the ISO 13485 standard to understand the requirements as well as practical methods to implement a successful quality management system. This course will also include discussions comparing ISO 13485 to ISO 9001, FDA, and European requirements.

Day 2 - Medical Device CAPA (includes FMEA, Risk Management & Warning Letters), Friday, March 30, 2012

Corrective and Preventive Action (CAPA) is a requirement under international standards such as ISO 13485:2003, ISO 9001:2008 and FDA under 21CFR 820.

This seminar will define and explain Corrective Action and Preventive Action requirements as found in ISO 13485 and FDA requirements. The course includes discussions on root cause analysis, quality system trending, corrective action effectiveness, and how CAPA is critical to be linked to other parts of the quality system including customer complaints, manufacturing nonconformities, customer feedback, supplier performance, etc. Lastly, this course will include the consequences of poor adherence to these principles. http://www.calfeed.com/events/1315-Medical-Device-Quality-Systems-CAPA-and-European-Medical-Device-regulations http://www.calfeed.com/1315 Thu, 10 Nov 2011 09:38:47 +0000 Course Description:

This 2-day seminar will provide valuable assistance and give a process and procedure to all regulated companies that are transferring equipment, molds, dies, systems and processes to suppliers. It will show how quality, verifications and validations process will meet today’s standards for the FDA and CE Mark.

This interactive workshop will guide you in the procedures and process of transferring equipment, tools or processes to meet the standards for the new medical industry. With the regulations for quality and validations getting more stringent with every transfer, it is imperative that companies are armed with the skills to plan and execute equipment, tools and process validations properly. All new products have to be designed and transferred to operations or a supplier in the same way. Validations need to meet all the new standards. This training will provide a step by step process to guide you in your transfer.

Areas Covered:

What procedures need to be in place to transfer equipment and processes to another facility in-house or to a supplier
Developing a Master Validation Plan
Developing Quality Plan
Gathering of data for a gap analysis
Risk management
Validations and quality procedures
How to chose the right “World Class” quality supplier
The transfer plan
The equipment transfer
The tool transfer
The assembly transfer
Validations and quality procedures
Multi-functional team approach/responsibility
Operations, quality and validations
Pit falls and downsides
Conduct a “Lessons Learned Program”

Who will benefit:

This seminar will provide valuable assistance and give a process and procedures to regulated companies that need to transfer equipment, molds, dies, systems and processes in-house or to suppliers with proper quality standards, procedures, verification and validations.

OEM plant managers and operation personnel in the medical industry
Manufacturing engineers
R&D, product development engineers and managers associated with validation of new products
QA, Regulatory Affairs and validation teams
Validation specialists
Senior management
Suppliers entering into the medical industry
Suppliers to the medical industry
Consultants
Corporate auditors

Meet Your Instructor

Mr.Rob Braido has 35 years of experience in the medical industry. He is presently the principle at Visionary Consulting LLC and has been consulting with medical OEM’s and suppliers to the medical industry for over 5 years.

Mr. Braido’s has a broad breath of industry experience in prototype/product development, global strategic/tactical planning, technical due diligence/gap analysis, engineering and strong leadership skills to help develop new products and businesses. He has had great success working at Ethicon Endo-Surgery a J&J Company, Teleflex Medical, The Tech Group and Baxter Healthcare with increasing responsibilities to the level of VP of Advanced Technologies. He was a member of the Board of Directors for the SPE Medical Division for over 10 years and elected Chairman of the Medical Division.

Mr.Michael Mims has 15 years of experience in medical manufacturing and is a six sigma black belt. Currently, Michael works for GW Plastics (Plastic News Processor of the Year 2010) as Plant Manager overseeing the contract manufacturing facility in Tucson, AZ. His facility was recognized as the plant showcase in Modern Plastics’ 2011 MD&M issue.

Mr. Mims is an expert at production transfer and startup because his experience also involves ongoing life cycle support and improvements. While at Abbott Nutrition, Michael was recognized as “Engineer of the Year” for his efforts in product and process improvements. http://www.calfeed.com/events/1320-Transferring-a-Medical-OEM-Molding-and-Assembly-Operation-to-a-Manufacturer-With-Validated-Systems-and-Processes http://www.calfeed.com/1320 Thu, 10 Nov 2011 09:53:04 +0000 This combined Quality Agreement and DMF (Drug Master Files) training will discuss the advantages for suppliers and drug product manufacturers in developing these arrangements together.

Why Should You Attend:

This course provides attendees with an understanding of the role that Quality Agreements and DMFs play in the FDA's regulatory approval process for drugs and biologics. http://www.calfeed.com/events/1333-Quality-Agreements-with-Pharmaceutical/-Biologic-Manufacturers-and-the-Use-of-Drug-Master-Files:-Understanding-and-Meeting-your-Regulatory-and-Processing-Responsibilities http://www.calfeed.com/1333 Fri, 11 Nov 2011 08:41:33 +0000 This webinar will cover Interviewing and Hiring in compliance with employment law and show how you can conduct the selection process with confidence.

Why Should You Attend:

The webinar will cover the selection process from beginning to end, adhering to applicable employment laws as well as gaining other tips to get to know your candidates and make the best match to the job. http://www.calfeed.com/events/1518-Complying-with-Legal-Interviewing-and-Hiring http://www.calfeed.com/1518 Fri, 27 Jan 2012 07:54:33 +0000 This 90-minute webinar will help exporters understand International Commercial Terms, or INCOTERMs, published by the International Chamber of Commerce and how to select the correct one for their transactions.

Companies that export and import products internationally need to understand which International Commercial Term, or INCOTERM, to use to precisely determine who pays for freight, insurance and customs duties. http://www.calfeed.com/events/1536-INCOTERMS---International-Commercial-Terms http://www.calfeed.com/1536 Mon, 30 Jan 2012 08:48:51 +0000 This environmental regulation training will explain in details the differences between California Environmental Regulations and U.S. EPA and Other State Requirements.

Why Should You Attend:

This webinar will explain, in a well-organized and effective manner, the key differences in regulations that any person responsible for environmental compliance in California needs to know. http://www.calfeed.com/events/1529-California-Environmental-Regulations-–-Differences-Between-Federal-EPA-and-State-Requirements http://www.calfeed.com/1529 Mon, 30 Jan 2012 08:28:55 +0000 This Medical device training will be discussing the requirements of the Medical Device Directives, their linkage to the EU Clinical Trial Directive and the requirements of CE Marking and ISO Certification on commercializing products.

Why Should You Attend:

This webinar is focused on understanding the requirements of the Medical Device Directives, their linkage to the EU Clinical Trial Directive and the requirements of CE Marking and ISO Certification on commercializing products. http://www.calfeed.com/events/1362-Medical-Devices:-EU-Directives-Guidance-Documents-CE-Marking-Process-and-ISO-Certification-Programs http://www.calfeed.com/1362 Fri, 11 Nov 2011 11:04:39 +0000 This 90-minute webinar on Disinfectant Qualification Studies will teach you disinfectant testing methodologies, provide examples of disinfectant efficacy tests and show how to troubleshoot problems related to disinfectant efficacy testing. http://www.calfeed.com/events/1503-Understanding-Disinfectant-Qualification-Studies-–-How-to-Avoid-Errors http://www.calfeed.com/1503 Fri, 27 Jan 2012 07:13:25 +0000 This webinar will teach you a methodology to perform experiments in an optimal fashion and review the common types of experimental designs and techniques.

Why Should You Attend:

Experimentation is frequently performed using trial and error approaches which are extremely inefficient and rarely lead to optimal solutions. http://www.calfeed.com/events/1533-Modeling-and-Optimizing-Process-Behavior-using-Design-of-Experiments http://www.calfeed.com/1533 Mon, 30 Jan 2012 08:40:33 +0000 This 90-minute webinar will help exporters and importers understand the Uniform Customs and Practice for Documentary Credits, UCP 600, published by the International Chamber of Commerce, Paris, France, Publication No. 600; which is the world’s standard for regulating Commercial Letters of Credit.

Companies that export and import products that use Documentary Letters of Credit to purchase and sell goods globally. The UCP is the international banking standard for issuing, advising, negotiating and paying Documentary Letters of Credit for 38,000 commercial banks worldwide. http://www.calfeed.com/events/1537-Uniform-Customs-and-Practice-for-Documentary-Credits http://www.calfeed.com/1537 Mon, 30 Jan 2012 08:51:20 +0000 Presentation Description:



This webinar describes efficient techniques for performing COTS validation. The 10-step risk-based approach to COTS software validation makes documentation more manageable and understandable. Learn how to increase productivity and minimize resources, usually saving two-thirds of the time and costs. Ensuring compliance of new and upgraded computer systems. Learn how to use risk management to improve system performance and promote process improvement. After you complete this webinar you will be ready to perform a validation project.



Who will Benefit?



Users of computer systems
IT
QA
QC
Laboratory staff
Managers
Executives



Learning Objectives:



· How to use the risk-based validation approach to lower costs.


· How to link requirements, specifications, risk management, and testing.


· Based on: "Risk-Based Software Validation – Ten Easy Steps" (Davis Horwood International and PDA - www.pda.org, 2006).


· Reduce testing by writing test cases that trace to elements of risk management.


· Learn which documents the FDA expects to audit.


· Proven techniques that reduce software costs and implementation times.


· Increase corporate productivity and individual workforce member productivity.


· Efficiently create validation documentation.


· Decrease resource requirements.


· Make documentation more manageable and understandable.


· Avoid 483s and Warning Letters.


· Use resources effectively to perform effective validation while avoiding doing too much.



- How to implement a computer system to gain maximum productivity.




About Speaker

Computer System Validation’s principal, David Nettleton is an industry leader, author, and teacher for 21 CFR Part 11, Annex 11, HIPAA, software validation, and computer system validation. He is involved with the development, purchase, installation, operation and maintenance of computerized systems used in FDA compliant applications. He has completed more than 206 mission critical laboratory, clinical, and manufacturing software implementation projects. His latest book is “Risk Based Software Validation - Ten easy Steps” (Davis Horwood International and PDA - www.pda.org, 2006) which provides fill-in-the-blank templates for completing a COTS software validation project. http://www.calfeed.com/events/1480-COTS-Software-Validation-–-10-Easy-Steps http://www.calfeed.com/1480 Fri, 13 Jan 2012 04:44:21 +0000 This webinar will help you understand the significant differences within the EU member states in relation to the way in which the Cookies laws within the 2009 E-Privacy Directive is being implemented and the challenges of complying with the Cookies law.

Why Should You Attend:

EU Directive 2009/136/EC amended Article 5(3) of the E-Privacy Directive and changed requirements from informed opt-out to informed opt-in. http://www.calfeed.com/events/1523-Complying-with-the-EU-Cookies-Law-Ecosystem http://www.calfeed.com/1523 Mon, 30 Jan 2012 08:05:54 +0000 How to Use excel spreadsheet for GXP data and reduce validation cost and time.

Why Should You Attend:

Learn how to create an Excel spreadsheet application that is GxP compliant. Understand how to validate your application with minimal documentation. Follow the step-by-step instructions as we configure Excel for audit trails, security features, and data entry verification. http://www.calfeed.com/events/1367-Excel-Spreadsheets;-develop-and-validate-for-21-CFR-Part-11-compliance http://www.calfeed.com/1367 Fri, 11 Nov 2011 11:16:53 +0000 Learn 10 major difference between Cal/OSHA and Federal OSHA and how to respond to it in case of OSHA inspection.

Why Should You Attend:

National and international corporations with plants and other establishments, like retail stores, in California need to be aware that compliance with federal OSHA standards is not sufficient in California, and that enforcement by Cal/OSHA is a more onerous experience compared to federal enforcement and other state plan enforcement. http://www.calfeed.com/events/1530-OSHA-–-10-Major-Differences-between-Federal-OSHA-and-California-OSHA-Compliance-and-Enforcement http://www.calfeed.com/1530 Mon, 30 Jan 2012 08:33:29 +0000 Understand 10 step Risk based approach to validation, explore methods to decrease resource requirements and make documentation more manageable and understandable.

Why Should You Attend:
This session explores proven techniques that reduce validation project time, often to one-third. Learn efficient documentation strategies for computer system validation and how to increase overall system productivity. http://www.calfeed.com/events/1368-Reduce-COTS-Software-Validation-using-the-risk-based-approach http://www.calfeed.com/1368 Fri, 11 Nov 2011 11:20:03 +0000 Learn how to perform risk assessment as part of the risk-based approach to computer system validation.

Why Should You Attend:

This webinar will show how you can determine and document risk in a process to reduce system validation time and ensure compliance. http://www.calfeed.com/events/1355-Risk-Assessment-Compliance-Using-Easy-To-Fill-Out-Documentation http://www.calfeed.com/1355 Fri, 11 Nov 2011 10:40:58 +0000