Establishing an Internal Audit Program of the Quality Management Systems Pursuant to ISO 13485 and 21 CFR Part 820 2014 is a webinar that covers topics such as:
- ISO 13485
- Statutes and Regulations
- Auditing Strategy
- Definitions
- Audit Planning, Frequency, Duration and Logistics
- Audit Objectives
- Various Audit Approaches
- How to Audit Quality Management Systems
- Quality Systems and Subsystems under 21 CFR Part 820
- Quality Systems and Subsystems in ISO 13485
- FDA and ISO 13485
- Comparative Overview of both ISO 13485 and 21 CFR Part 820
- Good Practices: Speaker’s Suggestions and Recommendations
Establishing an Internal Audit Program of the Quality Management Systems Pursuant to ISO 13485 and 21 CFR Part 820 2014 is intended for:
- Compliance Staff and Officers
- Quality Professionals
- R&D
- Regulatory Affairs
- VPs
- CEOs
- Clinical Affairs
- Attorneys
- Contractors/Subcontractors
- Consultants
- Anyone Interested in the Topic for ISO 13485 or 21 CFR Part 820