This water systems webinar training will discuss the myths surrounding microbial monitoring and control approaches and alert you to the pitfalls of believing these myths which could cause over-confidence in a system’s design for microbial control or the suitability of your microbial test methods.
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"This course is certified by Regulatory Affairs Professional Society (RAPS). Attendees of Live Webinar are eligible for 1.5 RAC Points up on full
completion of the course."
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Why Should You Attend:
Many water systems have been designed and are monitored using a set of rules taken out of context and in fact may be downright wrong or at least misguided -- what the author calls "Water System Myths".
Is your water system one of them? If it is, what can you do to make sure the system operates as intended, in spite of its non-optimal design? What can you do to optimize the testing? Attend this webinar and find out how we got into this predicament and what we can do to get out of it and begin building and operating efficient and effective water systems.
It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong. So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided? There are many reasons, which will be discussed, but regardless of the causes, we need to be aware of these myths and understand how it really should be done. A number of water system myths will be discussed that are related to microbial control approaches as well as microbial monitoring. Each myth will be explained as to its origin and then put into true context with how the supposed microbial control or monitoring approach SHOULD be handled. You will probably be surprised to learn which of your own "rules of thumb" are actually
based on “ Water System Mythology ”!
Areas Covered in the Seminar:
- Why water myths develop.
- Impact of c-GMPs
- Well-meaning but misguided precedents
- Scientifically unchallenged traditions and benchmarking
- Rule-hungry culture
- Water System Microbial Control Myths.
- WFI from RO
- Turbulent Flow and Flow Rate
- Dead Leg Rules
- Smooth Surfaces
- In-Line Sterilizing Filters
- Ozone
- Microbial Enumeration Myths.
- Referee Methods
- Thermopiles in Hot Systems
- R2A, 35°C, 5 days
- Test Filter Membrane Rating
- Compendial Action Levels
- TOC and Endotoxin as Microbial Count Correlates
Who Will Benefit:
This webinar will be valuable for all companies that operate WFI or Purified Water systems, particularly for those in FDA and EMEA regulated industries, including Medical Devices, Diagnostics, Pharmaceuticals, and Biologics fields, as well as consumer products and cosmetics companies. The employees who will benefit include:
- Validation managers and personnel
- Engineers involved in water system design and installation
- Utility operators and their managers involved in maintaining and sanitizing water systems
- QA managers and Regulatory Affairs personnel involved in defending water system operations and quality data to FDA and EMEA inspectors and outside auditors
- QA managers and personnel involved in investigations of excursions and preparing CAPAs
- QC laboratory managers and personnel involved in sampling, testing, and trending chem and micro data from water systems
- Consultants and Troubleshooters
Instructor Profile:
T.C. Soli, Ph.D, is President of Soli Pharma Solutions, Inc, with lecturing, auditing, and troubleshooting expertise covering water systems, sterilization, aseptic processing, contamination control, and microbiological laboratories. He has over 31 years of pharmaceutical experience as a consultant and with DSM Pharmaceuticals, Glaxo Wellcome, Burroughs Wellcome, and Pfizer. Dr. Soli’s career-long water systems and contamination troubleshooting, coupled with water-related USP, ISPE, PhRMA, and PDA committee involvements, afford him practical knowledge about process and contamination control; cleaning, sterilization and process validation; and all aspects of high purity water systems.
He is in his third 5 year term on USP Expert Committees responsible for Pharmaceutical Water, previously served 5 years on the Advisory Panel to the USP Microbiology Subcommittee, and helped develop the Water Conductivity and TOC specifications used by USP and adopted world-wide. He has authored many articles and chapters in books and industry guides published by USP, PDA and ISP.
