Implementing an Internal Audit Program of QMA, Persisting to ISO 13485 and 21 CFR Part 820

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This webinar is intended to help you adequately develop an internal audit program of a firm’s quality management system (QMS) as required by ISO 13485 or 21 CFR Part 820.

21 CFR 820.22 states “Each manufacturer shall establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system.”

This webinar will provide great opportunities to help you adequately establish your internal quality audit program with increased awareness and familiarity by employing risk- and process-based approaches pursuant to both ISO 13485 and 21 CFR 820.22.

At the end of the webinar, you will become familiar with the regulatory requirements for establishing an adequate internal audit program while bringing great benefits and added values to your firm’s quality management system and contributing to saving an enormous amount of resources.

This webinar is a must to attend to ensure the adequacy of your internal audit program in conformity with the requirements set out in the ISO 13485 and 21 CFR 820.22.

Areas to be Covered:

Statutes and Regulations
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

Who will Benefit:

Quality Professionals
Compliance Staff and Officers
Regulatory Affairs
Clinical Affairs
Anyone Interested in the Topic for ISO 13485 or 21 CFR Part 820

Dr. David Lim

Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor ( As a leading industry speaker, Dr. Lim frequently presents global regulatory and quality compliance topics in various forums and meetings. Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past eight years. Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.

Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker. Dr. Lim leads and directs all research projects including pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. Dr. Lim currently serves as a member of the Advisory Board for Inspection Insider published by FDA News.

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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance