Receipt for Jan. 20, 2005 Meeting West Coast Chapter ByLaws Board Meeting Minutes, March 2005 Board Meeting Minutes, November 2004 Board Meeting Minutes, March, 2003 Board Meeting Minutes, June 2003 Board Meeting Minutes, August 2003 Board Meeting Minutes, December 2003 Gail Burnett's QbD Presentation, July 19, 2007 Current Training and SOP Trends 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) ______________________________________________________ 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 Some files may require Reader 6 from Adobe® Chapter News for December, 2004 Chapter News for March, 2004 Chapter News for February, 2004 Chapter News for January, 2004 Chapter News for December, 2003 Chapter News for June, 2003 Chapter News for August, 2003 PDA notice about the European Commission’s GMP “Annex 1”
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Credit Card Form for June 12, 2008 Meeting
Presentations:
Robert Baffi's Presentaion: Post-Registration Process Changes: Considerations for Comparability November 20, 2008
Comparability Meeting Presentations:
"Introduction to Comparability" "Bayer" "BioMarin"
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