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Title: FDA, EU and other 3rd Party Medical Device Quality Audits
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| Description: | Description: This seminar will give an overview of the audit types and what to do when an external auditor visits. The talk will also concentrate on the similarities and differences between FDA and EU Notified Body operations and audit styles, concentrating on the medical device arena. This session will cover · Audit Types - Internal and External. · How to Prepare for External Audits. · Similarities and Differences between the FDA and EU. · Similarities and Differences between the FDA and EU Medical Device Audits. About the Speaker: George Gary Calafactor has over 25 years of scientific and regulatory experience in the medical device and pharmaceutical industries. He has held key positions including International Medical Device Investigator at US Food and Drug Administration, Medical Device expert at The FDA Group, as well as other positions with Gerson and Lehrman Group and Orchid Design. Mr. Calafactor holds a B.S. in Chemistry/Metallurgical Engineering from University of Notre Dame, a MBA in International Business from Indiana University and working on a Ph.D. in International Business from Northwestern University. Who should attend? US and Foreign Medical Device Quality Compliance Groups Regulatory Affairs QA Managers and Personnel Validation Specialists Consultants |
| URL: | http://www.fdaseminars.com/index_files/Register.htm |
| Date: | Thursday, March 11, 2010 |
| Time: | 12:00pm-1:00pm EST |
| Duration: | 1 hour |
| Access: | Public |
| Category: | Health*, Food and Beverage*, Environment*, Education*, Business* |
| Created by: | Public Access |
| Updated: | Sunday, February 28, 2010 11:53am EST |
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| : | fda_experts@yahoo.com |
| : | 407-260-2933 |
| : | 407-260-2933 |
| Comments: | None |
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