Aseptic Processing - Mar 31-Apr 1, 2005 - Philadelphia, PA

Aseptic Processing
Mar 31-Apr 1, 2005 - Philadelphia, PA
Park Hyatt Philadelphia
Inclusive Pre-Conference Workshop, Thursday, March 31, 2005
Clarifying the New FDA Guidance:
"Sterile Drug Products Produced by Aseptic Processing"
Les Edwards, Partner/Principal Engineer, Advanced Barrier Process, LLC
Austin McDonald, Senior Engineer and Partner, GL Engineering
Hear from Industry Leaders in the Areas of Global Harmonization, Environmental Monitoring, Avoiding 483 Citations, Designing Cleanrooms, Outsourcing to CMOs, Isolator Technologies, Lyophilization, and More!
* Explore the Scope, Technical Requirements, and Controversial Aspects of the New Aseptic Processing Guidance
* Prepare for FDA Inspections - Avoiding 483s, Warning Letters, and Product Recalls
* Explore Antimicrobial Regulations, Technologies, and Applications for Cleanrooms
* Achieve Harmonization of FDA, EMEA, ISO, and WHO Aseptic Requirements
* Improve and Maintain Aseptic Transfer Techniques
* Maintain Sterility and Prevent Cross-Contamination in the Lyophilization Process
* Pinpoint New Solutions and Techniques in Isolation Technology
FOCUS ON LYOPHILIZATION
* Clinical Scale Isolator- Based Aseptic Production of Liquid and Lyophilized Products
* Sterility Issues for the Lyophilization Process
* The Future "State of the Art" for Aseptically Processing Freeze-Dried Products
Event Sponsors
Biospace
PharmaVoice
Pharmaceutical Online

Location: Philadelphia, PA
Date: 03/31/05 - 04/01/05
Cost: $1,995.00