ComplianceOnline, Online Virtual Webinar
2012-06-28
Why Should You Attend: This interactive one-day course provides a thorough understanding of what makes water systems have microbial problems with proven solutions for microbial control. It also details how to validate that control by determining the operations and processes that logically must be evaluated in pharmaceutical water and steam systems during the validation exercise in a manner that will please FDA. Finally, and perhaps most importantly, attendees will learn how to institute simple sampling, monitoring and microbial control levels that will dramatically reduce microbial excursions and facilitate having successful and accurate root cause investigation outcomes. In short, if your job brings you in contact with any aspect of water system design, maintenance, trend monitoring, sampling, testing, sanitization, validation, responses to microbial excursions, root cause investigations, or regulatory interactions, you cannot afford to miss this invaluable training as well as the tips, tricks, and kernels of wisdom that this all-day webinar will give you. Duration: 6 hours of instruction, one hour lunch, and short breaks as they fit into the schedule. Agenda (times Eastern) - 10:00am (7am Pacific)-11:30 Module 1: Biofilm: Understanding What Makes Water Systems Have Microbial Problems (1:30)
- 11:30-1:00pm Module 2: Successful Sanitization and Microbial Control Approaches for Pharmaceutical Water Systems (1:30)
- 1:00-2:00 Lunch hour
- 2:00-3:30 Module 3: Purposeful Water and Steam System Validation – Not Just A Regulatory Requirement (1:30)
- 3:30-3:45 Afternoon break
- 3:45-5:15 Module 4: Reducing Microbial Excursions and Improving Investigation Outcomes (1:30)
- 5:15-5:30 Q&A
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Invited Speakers:
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Teri C. ("T.C.") Soli, Ph.D. is President of Soli Pharma Solutions, Inc, serving the Pharmaceutical, Biotech, Medical Device, Dialysis, Cosmetics and Personal Care Products and related equipment and instrument manufacturing industries with training, auditing, and troubleshooting expertise. He has over 32 years of combined pharmaceutical experience as a consultant as well as with operating companies such as DSM Pharmaceuticals, Glaxo Wellcome, Burroughs Wellcome, and Pfizer.
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