Thursday, 19 May
08:00 – 08:20 | Welcome and Day 1 Recap
08:20 – 09:15 | P5: Personnel Training, Qualification, Gowning, and Monitoring/Assessment
Moderator: Kurt Jaecques, GSK
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08:20 | Qualification and Training
Patrizia Muscas, Eli Lilly and Company
08:40 | Gowning and Personnel Monitoring
Cheryl Essex, Sanofi
09:00 | Q&A
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09:15 – 09:20 | Transition into Breakout Groups
09:20 – 09:45 | Breakout Session 4
Attendees will discuss the implementation challenges, and what can be done to meet those challenges, associated with the topics presented in P5: Personnel Training, Qualification, Gowning, and Monitoring/Assessment.
09:45 – 10:15 | Coffee Break, Poster Session & Exhibition
10:15 – 11:20 | P6: Production Technologies, Part 1
Moderator: Amanad Bishop McFarland, ValSource Inc.
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10:15 | Aseptic Processing
Alan Dake, Merck
10:45 | Filtration and Pre-use Post Sterilization Integrity Testing
Maik Jornitz, G-Con Manufacturing Inc.
11:00 | Q&A
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11:15 – 11:20 | Transition into Breakout Groups
11:20 – 12:00 | Breakout Session 5
Attendees will discuss the implementation challenges, and what can be done to meet those challenges, associated with the topics presented in P6: Production Technologies, Part 1 (Aseptic Processing and Filtration and Pre-Use Post Sterilization Integrity Testing).
12:00 – 13:00 | Lunch Break, Poster Session & Exhibition
13:00 – 13:50 | P7: Production Technologies, Part 2.
Moderator: Gabriele Gori, ThermoFisher, Scientific
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13:00 | Container Closure Integrity Testing and Finishing
Derek Duncan, Lighthouse Instruments
13:20 | Production and Specific Technologies (Blow-Fill-Seal, Lyophilization, Single Use System, and Terminal Sterilization)
Patrick Nieuwenhuizen, PharmaLex
13:40 | Q&A
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13:55 – 14:00 | Transition into Breakout Groups
14:00 – 14:30 | Breakout Session 6
Attendees will discuss the implementation challenges, and what can be done to meet those challenges, associated with the topics presented in P7: Production Technologies, Part 2 (Container Closure Integrity Testing and Finishing and Production and Specific Technologies (Blow-Fill-Seal, Lyophilization, Single Use System, and Terminal Sterilization)).
14:30 – 15:00 | Coffee Break, Poster Session & Exhibition
15:00 – 16:45 | P8: Aseptic Process Simulation/Environmental Monitoring
Moderator: Cheryl Essex, Sanofi
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15:00 | Environmental and Process Monitoring
Kurt Jaecques, GSK
15:20 | Aseptic Process Simulations
Gabriele Gori, ThermoFisher Scientific
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15:40 | Day 2 Report Out
16:00 | Q&A and Final Panel Discussion
16:45 | Closing Remarks & End of Workshop