subject: Raps Pre-approved Webinar On current Good Manufacturing Practice For Medical Devices Including Iv [print this page] Description: Description:
This webinar talks about the current Good Manufacturing Practice (cGMP) for medical devices, including in vitro diagnostic medical devices.
All medical devices are subject to Good Manufacturing Practice (GMP). This session will familiarize participants with the Current Good Manufacturing Practice (cGMP) present in the medical devices industry. This includes in-vitro medical devices. This session will also proffer guidance on the cGMP requirements as stated in the Quality System Regulations (QSRs), which ensure that medical devices are safe and effective for their intended use.
Why is an understanding of QSRs important? Because, showing deep understanding of QSRs helps speed up the approval process. The benefits of getting compliance of medical devices are there for everyone to see: a significantly enhanced saving of time, effort and resources. This webinar is a useful tool to helping participants gain a better understanding of how to bring these about.
A result of participation in this webinar is that participants will be better equipped to handle situations relating to which approach to take when implementing their cGMPs, and how to use their judgment and discretion for better results. This session will cover the following areas:
oOverview and review of the US QSRs for medical devices
oFlexibility of the QSRs
oDefinitions
oQuality System Requirements
oManagement responsibility
oAudits
oPersonnel
oDesign Control
oValidation, design transfer, and design changes
oDesign History File (DHF) and Device Master Record (DMR)
oQuality System procedures
oPurchasing controls
oInspection, measuring and test equipment
oProcess Validation
oCorrective and Preventive Action (CAPA)
oComplaint Files
oServicing
oQuality requirements for premarket approval (PMA) application
By whom:Dr. David Lim is a certified professional for regulatory affairs (RAC) and also is a certified quality auditor (CQA) by the American Society for Quality (ASQ). Dr. Lim obtained his Ph.D. in biological sciences at the University of Missouri-Columbia and published his thesis research in the prestigious journal, Science.
Dr. Lim is an auditor, regulatory coach, consultant and instructor for global matters pertaining to regulatory affairs and compliance, quality and clinical affairs. He is familiar with more than 200 medical products (medical devices including IVD products, biologics, drugs and combination products).
In 2009, Dr. Lim served as a member during the FDAs Transparency Public Meeting. Over the years, he has analyzed over 1,000 FDA warning letters. He has also attended more than 50 FDA Advisory Panel Meetings and analyzed the subject matters and decision-making processes in detail.
