Overview: This webinar is intended to help you get familiar with the current Good Manufacturing Practice (cGMP) for medical devices including in vitro diagnostic medical devices. This webinar is further intended to provide guidance on the cGMP requirements set out in the Quality System Regulations (QSRs), which help assure that medical devices are safe and effective for their intended use.
Understanding quality system regulations and requirements can significantly contribute to achieving compliance fast, resulting in saving significant amount of time and efforts and bringing quality and innovative medical products to the market faster. This webinar will discuss Quality System (QS) regulations, requirements and compliance. At the end of the webinar, you will get familiarized with the current Good Manufacturing Practice (cGMP) for medical devices including in vitro diagnostic medical devices.
At the end of the webinar, you will leave empowered in that you would take or choose to take different approaches when exercising your judgment and discretion.
Why Should You Attend: All medical devices are subject to good manufacturing practices. This webinar is intended to help you get familiar with the current Good Manufacturing Practice (cGMP) for medical devices including in vitro diagnostic medical devices.
Areas Covered in the Session:
Overview and review of the US QSRs for medical devices
Flexibility of the QSRs
Quality system requirements
validation, design transfer, and design changes
Design history file (DHF) and device master record (DMR)
Quality system procedures
Inspection, measuring and test equipment
Corrective and preventive action (CAPA)
Quality requirements for premarket approval (PMA) application
Enforcement actions: case studies
Who Will Benefit:
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.” Since then, Dr. Lim has held various positions at Duke, US National Laboratories, Intrexon Corporation, Terumo, US FDA/CDRH, and EraGen Biosciences, Inc., A Luminex Company.