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July 15:
| Keynote: Pharmaceutical Quality: Basic Expectations Ashley B. Boam, MSBE |
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| A Review Perspective on the Pharmaceutical Quality System Robert Iser, M.S. |
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| Production and Process Controls: Overview of CGMP Regulations and Regulatory Expectations Vibhakar Shah, Ph.D. Production and Process Controls: Regulatory Expectations for Microbiological Quality of Pharmaceuticals Vinayak B. Pawar, Ph.D. |
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| Laboratory Controls & Microbiology Testing – CGMP Regulations & Guidance John W. Metcalfe, Ph.D. Frank W. Perrella, Ph.D. |
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| Facilities & Equipment Regina T. Brown |
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| Q&A: Panel Discussion Day One Speakers |
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July 16:
| Materials System: Basic CGMP Requirements Alicia Mozzachio, R.Ph., MPH Minerva Hughes, Ph.D., R.A.C. |
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| Packaging & Labeling Allison A. Aldridge, Ph.D. Karen Takahashi, M.S. |
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| What to Expect During a FDA Drug Manufacturing Inspection Denise DiGuilio |
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| Case Studies Tamara Felton Clark |
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| Q&A: Panel Discussion Day Two Speakers |
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