Live webinar on "Establishing an Internal Audit Program of the Quality Management Systems Pursuant to ISO 13485 and 21 CFR Part 820" By comlpiance2go

DESCRIPTION

This 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 or for those who are subject to ISO 13485 and/or 21 CFR Part 820.
This webinar is also intended to greatly increase your awareness and familiarity with process-based approaches to internal auditing of quality management system requirements.

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.

Areas Covered in the Session:

Statutes and Regulations
ISO 13485
Definitions
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
Comparative Overview of both ISO 13485 and 21 CFR Part 820
FDA and ISO 13485
Good Practices: Speaker’s Suggestions and Recommendations
Conclusion

Who will benefit:

Quality Professionals
Compliance Staff and Officers
Regulatory Affairs
R&D
CEOs
VPs
Attorneys
Clinical Affairs
Consultants
Contractors/Subcontractors
Anyone Interested in the Topic for ISO 13485 or 21 CFR Part 820

Webinar Includes:

Q/A Session with the Expert to ask your question
PDF print only copy of PowerPoint slides
60 Minutes Live Presentation
Certificate of Attendance

For more Detal :- https://www.compliance2go.com/product/?pid=CP2014-287