Friday, 23 September
08:00 – 08:20 | Day 1 Recap
08:20 – 09:15 | Session 5: Personnel: Training, Qualification, Gowning, and Monitoring/Assessment
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08:20 | Qualification and Training
08:40 | Gowning and Personnel Monitoring
09:00 | Q&A |
09:15 – 09:55 | 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.
09:55 – 10:25 | Break
10:25 – 11:20 | Session 6: Production Technologies Part 1
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10:25 | Aseptic Processing
10:45 | Filtration and Pre-use Post Sterilization Integrity Testing
11:05 | Q&A |
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 and Exhibit
13:00 – 13:55 | Session 7: Production Technologies Part 2
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13:00 | Container Closure Integrity Testing and Finishing
13:20 | Production and Specific Technologies (Blow-Fill-Seal, Lyophilization, Single Use System, and Terminal Sterilization)
13:40 | Q&A |
13:55 – 14:35 | 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).
14:35 – 15:05 | Break
15:05 – 16:30 | Session 8: Aseptic Process Simulation/Environmental Monitoring
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15:05 | Environmental and Process Monitoring
15:25 | Aseptic Process Simulations
15:45 | Final Panel Discussion |
16:30 |Report Out
17:00 | Closing Remarks & End of Conference