Best Practices to Integrate: - FDA's Proposed Changes to Drug GMPs (Released December 2007) - EU GMPs: Annex 1 (Effective March 1, 2009) and Annex 2 - Risk Management and ICH Q8,9, and 10 - FDA's Quality Systems Regulation Attend Inclusive Pre and Post Conference Seminars:   A GMP Roadmap for Aseptic Processing Environmental Monitoring Program Design and Contamination CLEANROOMS: Facility Design and Equipment Selection Hear From: Amgen, Astellas Pharma, Merck, Pfizer, sanofi pasteur, Schering-Plough, and more! Learn From Over 10 Case Studies and 19 Interactive Sessions, Workshops, and Seminars that Include: Process Simulation (Media Fill), Container-Closure Systems, Terminal Sterilization, Gowning and Personnel Qualification, Rapid Microbial Identification, Sanitation and Sterilization Techniques, Aseptic Packaging, Cleaning Validation, and Much More!