cGMP for Medical Devices Including In Vitro Diagnostic Medical Devices

Duration: 60 Minutes
FDA states in warning letters "this inspection revealed that these devices are adulterated within the meaning of section 510(h) of the FD&C Act, in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the 21 CFR Part 820…" This webinar will address the said current good manufacturing practice requirements to help you stay in conformity with 21 CFR Part 820.
cGMPs
Instructor: David Lim
Product ID: 500029
Understanding cGMP requirements found at 21 CFR Part 820 can significantly contribute to achieving compliance fast, resulting in saving significant amount of time and efforts and bringing innovative medical products to the market faster.

This webinar is intended to help you get familiar with the current Good Manufacturing Practice (cGMP) requirements for medical devices including in vitro diagnostic medical devices. This webinar is further intended to provide guidance on the cGMP requirements of the Quality System Regulations (QSRs) found at 21 CFR Part 820, which helps assure that medical devices are safe and effective for their intended use.

This 60-min webinar will help you get familiar with the Quality System (QS) regulations and requirements that are necessary to achieve compliance and to remain compliant with 21 CFR Part 820 (cGMP for medical devices and IVDs).

Objectives of the Presentation:
  • US quality system regulations, flexibility, definitions and quality system requirements
  • Management responsibility, audits and personnel
  • Design control: design and development planning, design input, design output, design review, design verification, design validation, design transfer, and design changes
  • Design history file (DHF) and device master record (DMR)
  • Quality system procedures, purchasing controls and servicing
  • Inspection, measuring and test equipment
  • Process validation
  • Corrective and preventive action (CAPA) and complaint files
  • Quality requirements for premarket approval (PMA) application
  • Case studies and lessons learned
Who can Benefit:
  • CEOs
  • VPs
  • Compliance Officers
  • Attorneys
  • R&D and Manufacturing Managers
  • Managers (RA, QA/QC, CA)
  • Consultants
  • Contractors and Subcontractors
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$375
Recorded Session for one participant
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Recorded Session - How it works
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  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
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  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
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  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Dr. David Lim is President and Principal of Regulatory Doctor. Regulatory Doctor provides Practical, Actionable, and Sustainable Solutions in an Integrated, Thorough ("PASS-IT") manner.

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, Caltech, US National Laboratories, Intrexon Corporation, Terumo, US FDA/CDRH, and EraGen Biosciences, Inc., A Luminex Company. In 2009, Dr. Lim served as a panel 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. 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 thousands of FDA warning letters including thousands of MDRs. Dr. Lim has also attended more than 50 FDA advisory panel Meetings and analyzed the subject matters and decision-making processes. Dr. Lim is familiar with hundreds of 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 also is a regulatory coach, mentor, consultant and public speaker for global matters pertaining to regulatory affairs, regulatory compliance, quality and clinical affairs. Dr. Lim has been actively engaged in identifying and addressing regulatory hurdles and submission issues including, but not limited to, patient-safety signals and concerns. Dr. Lim co-authored the Regulatory Affairs Professional Society (RAPS)'s online class materials for EU medical device regulations.
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