Implementing an internal audit program for ISO 13485 and 21 CFR part 820

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Information about Implementing an internal audit program for ISO 13485 and 21 CFR part 820
Education

Published on March 13, 2014

Author: SusanPartov

Source: slideshare.net

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.

www.onlinecompliancepanel.com 510-857-5896 Implementing an Internal Audit Program Pursuant to ISO 13485 and 21 CFR Part 820 Live Webinar By Dr David Lim Date: Tuesday, March 18, 2014 @ 01:00 PM EST Duration: 60 minutes

www.onlinecompliancepanel.com 510-857-5896 President & Principal @ Regulatory Doctor Dr David Lim Dr. David Lim is President and Principal of Regulatory Doctor. Regulatory Doctor provides Practical, Actionable, and Sustainable Solutions in an Integrated, Thorough ("PASS-IT") manner. Dr. Lim obtained his Ph.D. in biological sciences at the University of Missouri-Columbia and published his thesis research in the prestigious journal "Science." Since then, Dr. Lim has held various positions at Duke, Caltech, US National Laboratories, Intrexon Corporation, Terumo, US FDA/CDRH, and EraGen Biosciences, Inc., A Luminex Company. In 2009, Dr. Lim served as a panel member during the FDA’s Transparency Public Meeting. Prior to founding his own consulting firm (www.RegulatoryDoctor.com), Dr. Lim was Senior Vice President of Scientific and Regulatory Affairs at Aquavit Pharmaceuticals, Inc. in New York. Dr. Lim as Regulatory Doctor provides practical, actionable and strategic solutions integrated with emotional intelligence (EQ) skills for all aspects of global regulatory, quality, clinical and compliance matters.

www.onlinecompliancepanel.com 510-857-5896 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. Objectives of the Presentation: •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

www.onlinecompliancepanel.com 510-857-5896 $243 Live Session for one participant $729 Corporate Live Session Up-to 5 participants. (For multiple location please contact our customer care team) $986 Corporate Live Session Up-to 10 participants. (For multiple location please contact our customer care team $288 Recorded Session Get unlimited access to the link for six months. (For multiple licenses please contact our customer care team) $489 CD Free shipment within 72hours, from the date of webinar completion. Webinar Registration Options: Live Session Options Recorded Session Webinar On CD Super Combo Offer: Live + Recorded session @ just $393

www.onlinecompliancepanel.com 510-857-5896 Book your spot today And get free access to a recorded session of your choice from our archives at no cost Contact Us: Susan Partov OnlineCompliancePanel 38868 Salmon Ter, Fremont California 94536 USA 510-857-5896 susapartov@onlinecompliancepanel.com www.onlinecompliancepanel.com

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