SBIA Education Events

US FDA – Center for Drug Evaluation & Research – Small Business & Industry Assistance

Focus on CGMPs & FDA Inspections 2015 Files

Click to Download the Agenda

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.
Slides: Download ZIP at top pf page
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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.
Slides: Download ZIP at top pf page
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Laboratory Controls & Microbiology Testing – CGMP Regulations & Guidance
John W. Metcalfe, Ph.D.
Frank W. Perrella, Ph.D.
Slides: Download ZIP at top pf page
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Facilities & Equipment
Regina T. Brown
Slides: Download ZIP at top pf page
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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.
Slides: Download ZIP at top pf page
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Packaging & Labeling
Allison A. Aldridge, Ph.D.
Karen Takahashi, M.S.
Slides: Download ZIP at top pf page
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What to Expect During a FDA Drug Manufacturing Inspection
Denise DiGuilio
Slides: Download ZIP at top pf page
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Case Studies
Tamara Felton Clark
Slides: Download ZIP at top pf page
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Q&A: Panel Discussion
Day Two Speakers
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