Device Master Record & Device History Record - Webinar By GlobalCompliancePanel

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Why should you attend: An FDA inspection will focus on the records you maintain. These records provide the objective evidence that demonstrates your QMS operates the way it should. While procedures are important, the supporting records demonstrate that you follow your own procedures. Much of the evidence is in the four records we discuss in the webinar. If you determine what you keep in each record and then follow your decision, you will have the evidence that you need. Moreover, a well organized set of records will help you lower cost in the QMS and provide valuable information when you need to investigate a problem and take corrective action. Your Quality Management System (QMS) should be able to address these questions quickly and easily. If not, then your team needs to attend this webinar!
Can you list the kinds of records that belong in the Design History File (DHF)?
Can your team relate the component specifications in the DMR to the Purchasing Data you use to obtain the components?
Does your team know the records you must keep when you verify the component at receiving?
Does you team know which of these records must go into the DHR?
Can your team list the activities that require a designated individual?
Do you have quality records that designate the individual and demonstrate training to perform the assigned responsibility?
Can you list the activities and the designated individuals in your company?
Can your team assure that the designated individual, not somebody else, performed the activity before you released the product for distribution?
Some information could be in the DMR or the QSR. Does you team know how to make the decision?
Areas covered in the session:
The FDA's QSR
The source of the requirements
The preamble
The QSR Manual
OMB information collection
Key Definitions
Design History File (DHF)
Requirements
Content
Quality System Record (QSR)
Device Master Record (DMR)
Contents
Linkage to Design Controls
Lessons for Implementation
Device History Record (DHR)
Contents
Linkage to the DMR
Lessons for Implementation
Who will benefit: This seminar is for people involved in project management, design, production, purchasing, installation, servicing, document control, and record keeping activities for medical device manufacturing. People in the following roles can especially benefit from the knowledge in this webinar:
Quality Managers
Quality Professionals
Regulatory Professionals
Production Managers
Risk Managers
Project Managers
Production Supervisors
Manufacturing Engineers
Production Engineers
Design Engineers
Process Owners
Quality Engineers
Quality Auditors
Document Control Specialists
Record Retention Specialists