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2013 Aseptic Conference 2013 Critical Utilities Conference

Conference Schedule

Monday, 4 March 2013
07.30 - 08.30	Continental Breakfast
08.30 - 08.45	Welcome and Introduction Charlotte Enghave Fruergaard, PhD, Director of Technology, NNE Pharmaplan Chairman, ISPE Board of Directors
08.45 - 09.45	Plenary Session with Q&A Rick Friedman, Associate Director, OMPQ, FDA
09.45 - 10.30	Networking Break
10.30 - 12.00	Track Presentations Aseptic Session Moderator: Joerg Zimmerman Barrier Isolation and Containment Session Moderators: Jack Lysfjord and Ryan Hawkins Sterilization and Cleaning Session Moderators: Gordon Leichter and Becky Brewer
12.00 - 13.00	Lunch in Exhibit Hall
13.00 - 14.30	Track Presentations Aseptic Session Moderator: Joerg Zimmerman Barrier Isolation and Containment Session Moderators: Jack Lysfjord and Ryan Hawkins Sterilization and Cleaning Session Moderators: Gordon Leichter and Becky Brewer
14.30 - 15.30	Networking Break in Exhibit Hall
15.30 - 17.00	Track Presentations Aseptic Session Moderator: Joerg Zimmerman Barrier Isolation and Containment Session Moderators: Jack Lysfjord and Ryan Hawkins Sterilization and Cleaning Session Moderators: Gordon Leichter and Becky Brewer
17.00 - 18.30	Networking Reception in Exhibit Hall

Tuesday, 5 March 2013
07.30 - 08.30	Continental Breakfast in Exhibit Hall
08.30 - 10.00	Track Presentations Aseptic Session Moderator: Joerg Zimmerman Barrier Isolation and Containment Session Moderators: Jack Lysfjord and Ryan Hawkins Sterilization and Cleaning Session Moderators: Gordon Leichter and Becky Brewer
10.00 - 10.30	Networking Break in Exhibit Hall
10.30 - 12.00	Track Presentations Aseptic Session Moderator: Joerg Zimmerman Barrier Isolation and Containment Session Moderators: Jack Lysfjord and Ryan Hawkins Sterilization and Cleaning Session Moderators: Gordon Leichter and Becky Brewer
12.00 - 13.00	Lunch in Exhibit Hall
13.00 - 14.30	Track Presentations Aseptic Session Moderator: Joerg Zimmerman Barrier Isolation and Containment Session Moderators: Jack Lysfjord and Ryan Hawkins Sterilization and Cleaning Session Moderators: Gordon Leichter and Becky Brewer
14.30 - 15.00	Networking Break in Exhibit Hall
15.00 - 15.30	Track Presentations Aseptic Session Moderator: Joerg Zimmerman Barrier Isolation and Containment Session Moderators: Jack Lysfjord and Ryan Hawkins Sterilization and Cleaning Session Moderators: Gordon Leichter and Becky Brewer
15.30 - 17.00	Regulatory Q&A Panel Panel Participants Rick Friedman, Associate Director, OMPQ, FDA, USA, Confirmed Destry Sillivan, Senior Regulatory Review Officer, FDA, USA, Confirmed Robert Sausville, Director, Division of Case Management (DCM) Office of Compliance and Biologics Quality, at FDA’s Center for Biologics Evaluation and Research, FDA, USA, Confirmed Dave Doleski, Acting Director, Division of Good Manufacturing Practice Assessment, OMPQ, OC, CDER, USA, Confirmed Tara Gooen, Senior Regulatory Operations Officer, FDA, USA, Invited Thomas J. Arista, Field Investigator, National Expert Pharmaceutical/Biotechnology, Office of Regulatory Affairs, Drug Inspection Branch, FDA, USA, Invited

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