Aseptic Processing and Filling - Practical Solutions for Overcoming Regulatory, Operational, Validation and Technology Challenges

Aseptic Processing and Filling - Practical Solutions for Overcoming Regulatory, Operational, Validation and Technology Challenges
July 18 - July 20 2005
Hyatt Fisherman's Wharf
San Francisco, CA
8:00 Morning Coffee
8:15 Chairperson's Re-Cap of Day One
Douglas Stockdale,
Aseptic Fill/Finish & Sterile Packaging Consultant,
STOCKDALE ASSOCIATES

Extended Case Study

8:30 Optimize Cleanroom Design, HVAC and Facility Layout for Aseptic Fill/Finish Processing Areas in Compliance with cGMP and Regulatory Requirements
Fred Nowbakh,
Mechanical Department Manager,
FLUOR
Robert Allen,
Technical Director, Facilities Integration Group,
FLUOR

9:45 Successful Optimization and Process Development for Aseptic Lyophilization
Anthony J. Cannon,
Associate Technical Director,
LYOPHILIZATION TECHNOLOGY

10:30 Morning Networking and Refreshment Break
10:45 Aseptic Filling Applications of Blow Fill Seal Technology
Patrick Poisson,
Director of Technical Engineering
CARDINAL

11:30 Best Practices in Aseptic Process Validation and Cleaning Validation
Moderator:
Douglas Stockdale,
Aseptic Fill/Finish & Sterile Packaging Consultant
STOCKDALE ASSOCIATES
Panelist:
Anthony J. Cannon,
Associate Technical Director
LYOPHILIZATION TECHNOLOGY
Patrick Poisson,
Director of Technical Engineering
CARDINAL
Rob Swift,
Senior Engineer, Container Engineering, Drug Product Process Development
AMGEN

12:30 Conference Concludes