Implementing an Internal Audit Program Compliant with ISO 13485 and 21 CFR Part 820

This online seminar (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 under 21 CFR Part 820 or for those who are subject to ISO 13485.

This webinar is also intended to greatly increase your awareness and familiarity with process-based approaches to internal auditing of quality management system requirements including FDA regulations affecting quality records and FDA’s policy on the reports required by the following regulations.

– 21 CFR 820.20(c) Management review
– 21 CFR 820.22 Quality audits, and supplier audit reports
– 21 CFR 820.50(a) Evaluation of suppliers, contractors, and consultants

Why You Should Attend:

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.

The speaker will present the regulatory requirements for medical devices in a CAC-SI manner. CAC-SI refers to current, accurate and complete/comprehensive in a systematic, integrated manner.

Areas Covered in the Session :

  • Statutes and Regulations
  • Definitions
  • ISO 13485 and 21 CFR Part 820 (QSR)
  • Auditing Strategy, Objectives, 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
  • Comparative Overview of both ISO 13485 and 21 CFR Part 820
  • FDA Regulations (21 CFR Part 11 and 21 CFR 820.180) and FDA Policy on Audit Reports
  • Good Practices: Speaker’s Suggestions and Recommendations
  • Instructor’s unique regulatory guide to provide practical, actionable and sustainable solutions in an integrated, through (PASS-IT) manner

Who Should Attend:

  • Research and Development Departments
  • Quality Departments
  • Regulatory Affairs Departments
  • Compliance Departments
  • CEOs and VP’s
  • Attorneys
  • Clinical Affairs Professionals
  • Consultants
  • Contractors / Subcontractors
  • Everyone Interested in training 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