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

MessageThis Webinar is over
Date Apr 16, 2014
Time 13:00
Cost $249.00
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
    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

Who Will Benefit:
    Quality Professionals
    Compliance Staff and Officers
    Regulatory Affairs
    Clinical Affairs
    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
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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