GMPs/Validation - BioPharm International

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GMPs & Validation
What you need to know about regulatory compliance, good manufacturing practices (GMPs), and validation, including evolving regulatory policy and developments in biosimilars.

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Administration Proposes Additional $275 Million Funding for FDA
June 10, 2008
Healthcare Reform Threatens Biotech Coverage and Access
June 1, 2008
Validation Failure is Not an Option. Should it be?
June 1, 2008
A Rational Approach for Setting and Maintaining Specs for Biological and Biotech–Derived Products—Part 1
June 1, 2008
Funding the FDA, Finally
June 1, 2008
USP Bioassay Workshop
Aug 13, 2008 - Aug 14, 2008
Rockville, MD
2008 PDA/FDA Joint Regulatory Conference
Sep 8, 2008 - Sep 12, 2008
Washington, DC
Biosimilars Conference
Sep 10, 2008 - Sep 11, 2008
Berlin, Germany
ISPE Conference on Product and Process Quality
Sep 15, 2008 - Sep 18, 2008
Manchester, United Kingdom
bioLOGIC Europe
Sep 16, 2008 - Sep 19, 2008
Geneva, Switzerland
Addition Vessels
Bioengineering AG
Characterization of anti-HCP Antibodies by 2D-HPLC
May 12, 2008
Asset Management for Growing Biotech Companies
May 9, 2008
Cleaning Validation: On-Site Trials of SpotView(R)
April 14, 2008
Fermentation Process Monitoring: Dissolved Carbon Dioxide
March 1, 2008
Rapid Characterization of Variable Regions of Monoclonal Antibodies by Top-Down Sequencing using Synapt HDMS
January 21, 2008
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SUMMARY: This category includes articles on good manufacturing practices (GMPs) and validation, including cleaning validation, contamination control, operator training, and risk management.

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