New FDA guidance on aseptic processing addressed at Aseptic Filling Conference in November

IIR conferences announced that Robert Darius, FDA-CBER, will be making the Keynote Presentation: FDA Insight into Correcting Aseptic Filling Compliance Deficiencies, at IIR’s upcoming Aseptic Filling Conference, Nov 3-5 2004, at the Doubletree Hotel in Philadelphia PA.

The mission of the Aseptic Filling Conference is to examine and clarify the updated regulatory environment. The conference focuses on integrating new technologies and implementing best practices in avoiding 483s.

FDA presenter Robert Darius identifies the latest FDA observations resulting from aseptic processing inspections and reviews, and offers advice on correcting deficiencies. Hear about the most often cited areas of deficiencies in 483s, including sterilization, barrier isolation, lyophilization and automated aseptic filling. He also reviews current FDA expectations for aseptic filling. This session is your opportunity to share and discuss actual case studies of 483s, so that your own systems can be made optimally compliant and effective.

Conference Presentations Incorporate New FDA Guidance on Aseptic Processing


Pre-conference workshop: Step-by-Step Overview of Aseptic Fill-Finish Requirements, Incorporating New FDA Aseptic Processing Guidance

Douglas Stockdale, Aseptic Fill/Finish & Sterile Packaging Consultant, STOCKDALE ASSOCIATES INC


Understanding the Regulatory Requirements, Expectations & Challenges of Aseptic Processing
Kenneth Christie, Sr Dir of Consulting Services, VTS CONSULTANTS

HVAC Design for Compliance & Qualification of Aseptic Processing Areas of Fill/Finish Facilities
Fred Nowbakh, Mechanical Dept Mgr, FLUOR

Standardizing Environmental Monitoring
Stephen Chew, Mgr of Microbiology-Lims, BAXTER BIOSCIENCES

Panel Discussion: Impact of 2003 FDA Draft Guideline on Sterile Drug Products Produced by Aseptic Processing

Container/Closure Systems for Aseptic Processing
Rob Swift, Sr Engineer, Container Engineering, Drug Product Process Development, AMGEN INC

Using Barrier Isolator Technology in Aseptic Filling
Hank Rahe, Technical Advisor for Containment Technologies, ENGUARD SYSTEMS

Bulk Product Handling
Wei Huang, Principle Process Engineer, FLUOR

Outsourcing Aseptic Fill/Finish to Contract Manufacturing Organizations
Douglas Stockdale, Aseptic Fill/Finish & Sterile Packaging Consultant, STOCKDALE ASSOCIATES INC

Sterile Lyophilization for Aseptic Filling

Aseptic Filling Applications of Blow Fill Seal Technology
Patrick Poisson, Dir of Tech Engineering, CARDINAL


For more information call 888-670-8200 or email [email protected].


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