Implementing an Internal Audit Program Pursuant to ISO 13485 and 21 CFR Part 820

Duration: 60 Minutes
This webinar is intended to help you get familiar with how to establish an internal audit program of the quality management systems (QMS) for medical device manufacturers in preparation for an FDA inspection or for those who are subject to ISO 13485 and/or 21 CFR Part 820.
ISO 13485
Instructor: David Lim
Product ID: 500232

This webinar is also intended to greatly increase your awareness and familiarity with process-based approaches to internal auditing of quality management system requirements.

At the end of the webinar, you will become familiar with the regulatory requirements for establishing an adequate internal audit program while bringing benefits and opportunities to greatly improve your quality management systems and to further save an enormous amount of resources pursuant to ISO 13485 and 21 CFR Part 820.

Objectives of the Presentation:
  • Statutes and Regulations
  • Definitions
  • Comparative Overview of both ISO 13485 and 21 CFR Part 820
  • Auditing Strategy
  • Audit Objectives
  • Audit Planning, Frequency, Duration and Logistics
  • How to Audit Quality Management Systems
  • Various Audit Approaches
  • Quality Systems and Subsystems in ISO 13485
  • Quality Systems and Subsystems under 21 CFR Part 820
  • FDA and ISO 13485
  • Good Practices: Speaker’s Suggestions and Recommendations
  • Conclusion
Who can Benefit:
  • Quality Professionals
  • Compliance Staff and Officers
  • Regulatory Affairs
  • R&D
  • CEOs
  • VPs
  • Attorneys
  • Clinical Affairs
  • Consultants
  • Contractors/Subcontractors
  • Anyone Interested in the Topic for ISO 13485 or 21 CFR Part 820
$375
Recorded Session for one participant
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  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • 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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