| June 17, 2010 - Mike Wiebe, President, Quantum Consulting, Virus Contamination of Cell Culture Operations - A Question of When, Not If
November 12, 2009 - Mark S. Roh, Regional Food and Drug Director, Pacific Region, FDA - A Revised Vision for Effective Enforcements and Benefits to the Public Health
September 24 Presentation - Implementation of Rapid Microbiological Methods - Michael J. Miller, Ph.D.
July 23, 2009 - Hot Topics in Visual Inspection
John Shabushnig's Presentation
PDA Survey of Industry Practice for Visual Inpection
March 26, 2009 Guidance for Industry cGMP for Phase I Investigational Drugs Presentations:
Melissa Morondi – Guidance for Industry cGMP for Phase I Investigational Drugs
Elizabeth Leininger – Guidance for Industry cGMP for Phase I Investigational Drugs - Regulatory Perspective
Zhengtian "Titan" Gu – A Perspective on Guidance on cGMP for Phase I Investigational Drug
William "Rick" Srigley – Manufacture of Phase I Investigational Drugs
Robert Baffi's Presentation: Post-Registration Process Changes: Considerations for Comparability November 20, 2008
Gail Burnett's QbD Presentation, July 19, 2007
Current Training and SOP Trends
Lynn Torbeck, OOS Final Guidance, Jan 25 2007 Meeting
Aseptic Processing Panel Discussion, Nov. 30, 2006
Aseptic Processing Areas, K. Vadheim
Personnel Training & Process Simulation, J. Chen
Aseptic Processing, J. Cheung
"FDA Coming Attractions: What You Need To Know" (9/28/06)
Comparability Meeting Presentations:
"Introduction to Comparability" "Bayer" "BioMarin"
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Managing TSE Risk For Biotech Products
Root Cause Analysis Presentation
Validation With Designed Experiments
FMEA Presentation
Qualifying Raw Materials
An Overview of FDA's New Aseptic Guidance Document
Managing Quality Oversight
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