2014 - Webinar On Implementing an Internal Audit Program of QMA, Persisting to ISO 13485 and 21 CFR Part 820

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
Definitions
Comparative Overview of both ISO 13485 and 21 CFR Part 820
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
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
Price Tags:
Single Live : For One Participant
$ 249
Corporate Live : For Max. 10 Participants
$ 899
Recording
Single REC : For One Participant - Unlimited Access for 6 Months
$ 299
Speaker Profile
Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor (www.RegulatoryDoctor.com). 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. Dr. Lim leads and directs all research projects including pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor.
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