globalcompliancepane

(bit.ly) – he Microbiology Lab must take leadership in contamination control support for production because it is the hub of the necessary technical expertise. Read More

(bit.ly) – This interactive webinar provides explicit details and live demonstration followed by a collaborative workshop that explains how to configure and validate a GxP compliant spreadsheet applica... Read More

(www.globalcompliancepanel.com) – : Auditing analytical laboratories can be complex because of the preparation that is often required. All of the GMP rules do not apply to the laboratory; while there may be additional requir... Read More

(bit.ly) – The FDA's Quality System Regulation (QSR) prescribes the Quality Management System for a medical device manufacturer who markets in the US. ISO 13485 covers the rest of the world. The w... Read More

(bit.ly) – This webinar is not a project management certification course. It is designed to provide the tools necessary to assist those designing a result or deliverable to achieve that end. It will pr... Read More

(bit.ly) – This CAPA training program helps you to understand, in 10 easy steps, the entire CAPA process. It includes elements of Quality Tools, Team Effectiveness, Awards & Recognitions, and Verif... Read More

(bit.ly) – This webinar will cover the various methods used to determine residual moisture in products ranging from bulk powders, to sterile freeze-died products in vials, to foods. Understanding the d... Read More

(bit.ly) – Major postmarketing vigilance revisions are now in force. A revised medical device guidance document on postmarketing vigilance (MEDDEV 2.12-1 rev 5) came into force on January 1, 2008. Prov... Read More

(bit.ly) – The top management of a company is responsible for ensuring that all regulatory requirements are met. This concept is codified in both the QSR and ISO 13485. FDA officials have repeatedly st... Read More

(bit.ly) – The U.S. Food and Drug Administration issued the final rule establishing regulations to require current good manufacturing practices (CGMPs) for dietary supplements. Read More

(bit.ly) – In the area of product design, one of the most critical and least understood phases is Design Validation at the interface with Process Validation. The international standard on medical devic... Read More

(bit.ly) – Overview: The FDA’s Quality System Regulation (QSR) explains how a device manufacturer must manage suppliers. This ranges from supplier evaluation and selection to control methods. One com... Read More

(bit.ly) – Overview: This webinar teaches how to determine and document risk in a process in order to reduce validation time and ensure compliance. What makes this session unique are the real life ... Read More

(bit.ly) – This webinar will examine the stated intent of the Agency to get tougher across the board in its expectations for the medical industry and its compliance to the cGMPs. Read More

(bit.ly) – Lyophilization cycle scale-up and cycle transfer between dryers has traditionally been one of the most challenging issues in manufacturing. Cycles that have been designed on development-scal... Read More

(bit.ly) – A 510(k) is a premarket submission made to FDA to demonstrate that your device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed devi... Read More