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
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:
Compliance Staff and Officers
Research & Development
Chief Executive Officers
Anyone Interested in the Topic for ISO 13485 or 21 CFR Part 820