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November Schedule:
Thursday, November 20, 2008 “A Quality Systems Approach to Cleaning Validation” Speaker: Frank S. Kohn, PhD Learn More>>> 2-Session Live Web Training Curriculum: November 24, November 25, 2008 “Japan – Understanding the Structure, Regulatory Requirements and Compliance Processes for the Pharmaceutical, Medical Device and Biotech Industries” Speaker: Robert J. Russell Learn More>>> Wednesday, November 26, 2008 "Preparing for FDA Inspections of Biologics and Biotech Facilities" Speaker: John R. Godshalk, Ex-FDA Learn More>>>
December Schedule Tuesday, December 2, 2008 An Inclusive One-Day Live Web Training Curriculum “Operating a GLP Compliant Laboratory; a Comprehensive Course on GLPs” Speaker: Nanda Subbarao, PhD Learn More>>> Thursday, December 4, 2008 “Current Trends of a Global Stability Program” Speaker: Kim Huynh-Ba Learn More>>> Friday, December 5, 2008 "Regulatory Aspects of Computer Systems Validation (CSV) and Part 11" Speaker: Johnny Guerra, ex-FDA Learn More>>> Wednesday, December 10, 2008 "Change Control under the cGMP’s and fGMP’s, for the 21st Century" Speaker: Charles S. Levine Learn More>>> Thursday, December 11, 2008 "Investigating Out-Of-Specification (OOS) Test Results for Pharmaceutical Production" Speaker: Johnny Guerra, ex-FDA Learn More>>> Thursday, December 18, 2008 "Laboratory Instrument and Equipment Qualifications" Speaker: Johnny Guerra, ex-FDA Learn More>>>
For a partial list of our 2009 topics, please click here |