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Conference Day Three, Thursday, June 19, 2008 7:30 AM- Continental Breakfast and Exhibit Viewing 8:30 AM-10:00 AM 90-minute Interactive Workshops Session 7 Aseptic Processing Guidelines and Strategies for Gowning and Personnel Qualification Gillian Edwards, M.S., SM (NRM), RM (NRM), Pharmaceutical and Medical Device Quality Consultant  slides 3 slides to a page with notesI. Regulatory Expectations and Inspectional Observations II. Gowning and Personnel Qualification Procedures III. Gowning and Personnel Qualification Acceptance Criteria, Excursions, and Requalification IV. Interactive Exercise: Case studies on personnel qualification compliance issues will be presented to attendees for discussion. Session 8 Biological Product Deviation Reports: FDA and EU GMP Deficiencies Felicia Ford-Rice, Senior Director, Quality Assurance, Astellas Pharma US, Inc. CANCELLED I. FDA and EU Regulations II. Sterile Product and Terminally Sterilized Product Inspections III. Case Study: Participants will review FDA Warning Letters on sterile product and aseptic processing. IV. Toolkit: Participants will receive: A Tabulated GMP Deficiencies, GMP Regulations and Quality Systems: A comparison of the US and the EU Session 9 Aseptic Processing and Terminal Sterilization Processing David Vincent, CEO, Validation Technologies, Inc. slides3 slides to a page with notesI. Regulatory Expectations for Terminal Sterilization II. Validation Approaches and Performance Terminal Sterilization III. Interactive Exercise: Review and Discussion on Current 483 and Warning Letters Related to Aseptic Operations and Terminal Sterilization Participants will discuss issues related to current FDA inspection trends and expectations and analyze inspection citation related to aseptic operations and terminal sterilization. 10:00 AM- Refreshment Break and Exhibit Viewing 10:30 AM-12:00 PM 90-minute Interactive Workshops Session 10 Aseptic Container- Closure Systems and Leak Testing in Today's Regulatory Environment William H. Fleming, III, Ph.D., Senior Director, Corporate Microbiology, MedImmune, Inc. slides3 slides to a page with notesI. FDA and International Requirements II. Developing and Testing the Container-closure Integrity System III. Case Study- Closed Filling System in a Vaccine Manufacturing Environment: Using a case study from a vaccine manufacturing facility, attendees will develop the data package for submission of the new system. Session 11 Process Simulation (Media Fill) from a Parenteral Vial Fill Perspective Gillian Edwards, M.S., SM (NRM), RM (NRM), Pharmaceutical and Medical Device Quality Consultant slides3 slides to a page with notesI. Regulatory Expectations and Inspectional Observations II. Media Fill Procedures III. Media Fill Failures and Invalidation IV. Interactive Exercise: A case study focusing on media fill excursions and product release will be presented to attendees for comment and discussion. V. Toolkit: Participants will receive: Example SOP for microbiological procedures. 12:00 PM- Lunch and Exhibit Viewing 1:00 PM-4:30 PM Inclusive Post-Conference 3-Hour Workshop CLEANROOMS: Efficient, Cost-Effective Facility Design AND Process Equipment Selection Raj Jaisinghani, PE., President, Technovation Systems, Inc. slides 3 slides to a page with notesI. Development of Design Specifications II. Airflow Rate Design Overview III. Air Handling Systems- Advantages and Disadvantages IV. Cost Comparison for Optimized Engineering Design vs. Conventional Design V. Process Equipment on Cleanroom Performance VI. The Dilution Model & Method for Equipment Particle Generation Characterization VII. Examples of Dilution Model Analysis for G Determination VIII. Toolkit: Participants will receive: Copies of Publications regarding Dilution Model by Raj Jaisinghani, A Design/build CD catalog, Design Spec List, Free Transient Analysis Request Form for your upcoming cleanroom project, Copies of Publications regarding Airflow Modeling by Raj Jaisinghani 4:30 PM- Close of Conference |
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