June 18-19, 2012 | Conrad Chicago | Chicago, Illinois
LAST CHANCE TO REGISTER! - Conference Starts In 9 Days!
Attendees receive a FREE copy of PDA Technical Report No. 22 Revised 2011: Process Simulation for Aseptically Filled Products.
2012 PDA Innovation & Best Practices on Sterile Technology Conference will include presentations from regulatory and industry representatives from around the world who will share recent case studies, current and future trends for sterile product manufacturing.
Opening Plenary Session: Applying Quality Risk Management in Sterile Manufacturing - Case Studies. This opening session will explore the integration of ICH Q8, Q9, and Q10 to develop, implement and sustain a sterile drug product manufacturing control strategy
Regulatory updates from the FDA:
• John Metcalfe, PhD, Senior Microbiology Review, New Drug Microbiology, CDER, FDA to present on Current Regulatory Review Hot Topics
• Rebecca Rodriguez, National Drug Expert Investigator, ORA, FDA to speak on Validation of the Aseptic Process and Inspection Trends From a Regulatory Perspective
Plenary sessions on topics such as:
• Contamination Control and Remediation
• Application of PDA TR No. 1 Sterilization Science Concepts
• Evolving Novel Sterilization Technology
• Case Studies on Risk Based Approaches for Sterile Product Facility Design
• Trends in Sterile Product Manufacturing Regulatory Expectations
• PDA Technical Report: Answers to Your Sterile Product Questions
• Ask the Experts Panel Discussion - The Future of Sterile Product
• Manufacture - Trends, Issues and Solutions
IG meetings for Clinical Trial Material and Sterile Processing/Blow-Fill-Seal
A series of new and revised PDA Technical Reports on sterilization and aseptic processing will be showcased as well as a brief update to USP's Sterilization Chapters and the rewrite of USP .
And much more
Immediately following the conference PDA TRI will be hosting four stand alone courses to complement your learning on June 20-21, 2012.
Register - Conference Starts in Just 9 Days!
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