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EVENT DETAILS

Prepare for "FDA Inspection" Review Recent Warning Letters- Aseptic Processes

June 28-29, Philadelphia, PA

Jeanne Moldenhauer has over 25 years experience in the pharmaceutical, biotechnology and medical device industries. She has authored several books and numerous publications including topics on quality, biological indicators, sterilization, rapid microbiology, comparability protocols, and inspections. Her most recent book: Recent Warning Letters Review for Preparation of an Aseptic Processing Inspection.

Barry A. Friedman, Ph.D., is a Senior Consultant in the Biotechnology, Regulatory Compliance and Aseptic Processing arena. From 2000 to 2007, Dr. Friedman was associated with Cambrex Bio Science Baltimore, a contract manufacturer of GMP bulk biopharmaceuticals located in Baltimore, MD.

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NEWS:

February 2012
Abbott Vascular and Novatek
Novatek Successfully passed Abbott Vascular on site Regulatory Audit
February 2012
West-Ward Pharmaceuticals, a subsidiary of Hikma PLC – Portugal, Germany & USA
West-Ward Pharmaceuticals, a subsidiary of Hikma PLC has chosen Novatek’s microbiology environmental monitoring software program
January 2012
Novartis Animal Health Canada Inc.
Novartis Animal Health Canada Inc., an affiliate of Novartis AG has chosen Novatek’s microbiology environmental monitoring software program

EVENTS:

Pittcon Conference & Expo - Booth 1884
March 12-15, 2012 - Orlando, FL
2012 PDA Annual Meeting - Booth 512
April 16-18, 2012 - Phoenix, AZ
PDA/FDA Joint Regulatory Conference - Booth 21
September 10-12 - Baltimore, MD
PDA’s 7th Annual Global Conference on Pharmaceutical Microbiology - Booth 19
October 22-24, 2012 - Bethesda, MD
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