| Wednesday, June 13, 10:00 am - 11:45 am | |||
| Presenting: Design Controls - Concept & Feasibility to Commercialization | |||
| Wednesday, June 13, 3:15 pm - 4:00 pm | |||
| Presenting: Dissecting the FDA Warning Letter | |||
| Thursday, June 14, 10:00 am - 12:00 pm | |||
| Presenting: FDA Inspections Workshop | |||
| Biographical Information | |||
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Mr. Gagliardi's successful 40-year track record in the Medical Device and Pharmaceutical industries stems from his practical approach to process orientation and business. He has been actively involved in research and development, quality assurance, training, operations, process architecture, FDA inspections and regulatory affairs. John specializes in building systems in a compliant and business-ready manner. |
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Further Resources |
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Company Web Site: www.midwestprocessinnovation.com |
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BONEZONE: The Anatomy of a Warning Letter, Part Two: Excerpts and Response Strategies
(June 2012) |
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| BONEZONE: The Anatomy of a Warning Letter: A Primer (March 2012): |
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BONEZONE: Planning for the Unpredictability of Change
(December 2011): |
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All BONEZONE Articles by John Gagliardi: http://www.bonezonepub.com/author-search?author=122 |
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