This is the place to download meeting minutes, text or PDF files, and link to or contact speakers for copies of presentations.

Minutes & Forms Presentations PDA National

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Credit Card Form for June 12, 2008 Meeting

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


Presentations:
Robert Baffi's Presentaion: Post-Registration Process Changes: Considerations for Comparability November 20, 2008

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)

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


From National PDA:

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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”