Conference Day Two, Wednesday, June 18, 2008 7:30 AM-  Continental Breakfast and Exhibit Viewing 8:20 AM-  Chairperson's Welcome and Opening Remarks 8:30 AM-   Industry Perspective of Sterile Operations from a Former FDA                    Official                    Kristen D. Evans, Amgen 9:15 AM-   Direct Final Rule/Proposed Rule?  Changes to CFR, EU GMPs, Q10 and...Q11                    Karen S. Ginsbury, B. Pharm. M. Sc. MRPharmS., President, PCI Pharmaceutical                 Consulting Israel Ltd.                 slides                      3 slides to a page with notes                    10:00 AM- Refreshment Break and Exhibit Viewing 10:30 AM- Aseptic Processing- EU GMPs; Compliance with Annex 1 &2; an EU                     Country Perspective CANCELLED                     Robert Gumbleton, B. Sc./Dip. M&IR, Manager Quality Support,                  Schering-Plough (Brinny), IRELAND 11:15 AM- Panel Discussion: What Does FDA's Proposed Changes to Drug                      GMPs and the EU GMP Annex I Mean to Your Company? CANCELLED                     Robert Gumbleton, B. Sc./Dip M&IR, Manager Quality Support,                  Schering-Plough (Brinny), IRELAND                     Kristen D. Evans, Director Global Quality Compliance, Amgen 12:00 PM-  Lunch  1:00-2:30 PM 90-minute Interactive Sessions Session 1  Designing a Cleaning Validation Process for Aseptic Manufacturing  Vivienne Yankah, Ph.D., CQE, Manager Process Improvement Sciences, sanofi pasteur Limited, Toronto, Canada  Slides 3 slides to a page with notes I.      Implementing Quality in Designing the Cleaning Process II.    How to Design the Cleaning Process in an Aseptic Environment III.   Executing the Cleaning Validation Process IV.   Maintaining the Cleaning Process V.    Interactive Exercise: Using a case study for cleaning validation in an aseptic        environment, attendees will discuss content information for generating cleaning       validation protocols, document raw data, and reports. Session 2  Aseptic Packaging Process- Equipment Selection Tools Thomas J. Cornish, PMP, Pfizer slides 3 slides to a page with  notes I.    General Aseptic Flow & Processes for Primary Packaging II.   Formulation & Sterilization Equipment Selection III.  Filling/Freeze Dry Operations IV.   Interactive Exercise: Developing Documents: Using a case study attendees will develop selected documentation for requirements gathering and vendor selection. Session 3  Food and Drug Administration (FDA) Inspectional Findings of an Aseptic Filling Operation and Sterile Processing David Vincent, CEO, Validation Technologies, Inc.  Slides  3 slides to a page with notes Every manufacturer has its problems with aseptic processing.  Each has its way of handling the problem.  This presentation will review some of the common problems routinely acknowledged within the industry in aseptic processing. I.    Regulatory Expectations and Industry Drivers II.  FDA Expectation Related to Cleanroom Operations III. Current FDA Expectation during Inspection of Sterile and Aseptic        Operations IV. Interactive Exercise: Review and Discuss Current 483 and Warning Letters.       Participants will discuss issues related to current FDA Inspection trends and      expectations, and also analyze inspection citation related to aseptic operations. 2:30 PM- Refreshment Break and Exhibit Viewing 3:00-4:30 PM 90-minute Interactive Sessions Session 4  Sanitization and Sterilization Techniques for Cleanrooms Jim Polarine Jr., MA., Technical Service Specialist, STERIS Corporation  Slides  3 slides to a page with notes I.    Ensure Your Cleaning and Disinfection Program is Effective II.   Troubleshooting Methods of Application of Sanitizers, Disinfectants,         and Sterilants III. Safety related to application and application techniques of sanitizers,        disinfectants, and sterilants IV.  Interactive Exercises: Two different cases related to application methods       will be conveyed, and the audience will be asked to troubleshoot the cases. V.   Toolkit: Participants will receive: A Copy of USP 29 NF-24 Disinfectants and        Antiseptics and A Copy of the European Annex I Section on Disinfectants       (2007) Session 5  Rapid Microbial Identification- What is Truly Possible? William H. Fleming, III, Ph.D., Senior Director, Corporate Microbiology, MedImmune, Inc.  Slides  3 slides to a page with notes I.    What is a Rapid Microbial Identification Method? II.    Methods Currently Available that Qualify as a Rapid Microbial          Identification System III.  Case Study: Validate and Incorporate A Rapid Microbiology Identification          System: Using a case history from a vaccine manufacturing environment,        attendees will develop the validation approach and the incorporation strategy       for a rapid microbial identification system. Session 6  Microbial Risk Assessment for Aseptic Processing Dilip Ashtekar, Ph.D., Chief Microbiologist and Director of Sterility Assurance, Amgen  Slides  3 slides to a page with notes I.    Requirements for Risk Assessment II.  How to Perform Risk Assessment III. Evaluate the Efficiency of CAPA 4:30 PM- End of Day Two 5:00 PM- Networking Cocktail Reception