Current Good Manufacturing Practice for Medical Devices Including IVDs

Training Options

  •   Duration: 60 Minutes  
  • Recorded Access recorded version only for one participant; unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
    Price: $275.00
  • Refund Policy

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
  • Definitions
  • Quality system requirements
  • Management responsibility
  • Audits
  • Personnel
  • Design control
  • validation, design transfer, and design changes
  • Design history file (DHF) and device master record (DMR)
  • Quality system procedures
  • Purchasing controls
  • Inspection, measuring and test equipment
  • Process validation
  • Corrective and preventive action (CAPA)
  • Complaint files
  • Servicing
  • Quality requirements for premarket approval (PMA) application
  • Enforcement actions: case studies
  • Lessons learned

Who Will Benefit:
  • CEOs
  • VPs
  • Compliance officers
  • Attorneys
  • Clinical affairs
  • Regulatory affairs
  • Quality assurance
  • R&D
  • CROs
  • Consultants
  • Contractors/subcontractors

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. In 2009, Dr. Lim served as a member during the FDA’s Transparency Public Meeting. Prior to founding his own consulting firm (www.RegulatoryDoctor.com), Dr. Lim was Senior Vice President of Scientific and Regulatory Affairs at Aquavit Pharmaceuticals, Inc. in New York, wherein Dr. Lim provided inspiring and actionable solutions for sustainable business operation. Dr. Lim as Regulatory Doctor provides practical, actionable and strategic solutions integrated with emotional intelligence (EQ) skills for all aspects of global regulatory, quality, clinical and compliance matters. Over the years, Dr. Lim has analyzed over 1,000 FDA warning letters. Dr. Lim has also attended more than 50 FDA Advisory Panel Meetings and analyzed the subject matters and decision-making processes in detail. Dr. Lim is familiar with more than 200 medical products (medical devices including IVD products, biologics, drugs and combination products). Dr. 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 is an auditor, regulatory coach, consultant and instructor for global matters pertaining to regulatory affairs and compliance, quality and clinical affairs.


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