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
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.
- Statutes and Regulations
- 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.
Dr David Lim,
President and Principal Consultant ,
Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor. 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 seven 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, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor.