USP Workshop—Advances in Microbial Control and Product Quality

Co-sponsored by the Parenteral Drug Association (PDA), this workshop brought together all levels of industry professionals to network and benefit from shared knowledge and expertise related to microbial control and parenteral drug product quality.

Topics:

• The role of microbiology in Quality by Design, including managing microbial risk, microbial contamination control and risk management in aseptic processing/manufacturing
• Current trends in environmental monitoring and the economic aspect of microbiology ("lean laboratories" and the Return on Investment for Rapid Microbiology Methods)
• Appropriate strategies for maintaining a non-sterile manufacturing environment (the importance of microbial identification, testing for and understanding the impact of objectionable organisms and resolving microbial challenges associated with non-sterile operations)
• New advances in rapid microbiological methods, microbial identification technologies, endotoxin testing and the use of statistics during data review and validation activities
• Elements of a sterility test failure investigation
• Local regulatory and pharmacopeial expectations

When: October 25–27, 2010

Where: PDA's 5th Annual Global Conference on Pharmaceutical Microbiology; Washington, DC, USA

Event Program: Final Brochure

Participants:
Executives, managers, and scientists/technicians (researchers, analysts, bench personnel) who work in:

• Microbiology
• Compliance
• Engineering
• Manufacturing
• QA/QC
• Regulatory affairs
• Research & development
• Validation