Curtailing Microbial Excursions and Investigations in Pharmaceutical Water Systems
10:00 AM PDT | 01:00 PM EDT
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Water system microbial excursions are the bane of laboratories, utility operations, and production, often causing huge expenditures of labor for system sanitization and additional testing and quarantines of whole systems or specific outlets while fruitless investigations are mounted, not to mention the potential cost of product rejections when root causes are not definitive.
Though some excursions are real and a sign of system control problems, most are probably self-inflicted, being caused by poorly designated "trigger values", poorly designed use points, or poorly executed sampling or testing. This presentation will explore these possible causes, including the symptoms of real (as well as false) water system problems, and provide effective alternatives to avoiding most of your current superfluous excursions, as well as how to build supporting data useful in pinpointing causes when investigations are indeed necessary.
Why should you Attend:
When was the last time you performed a water system excursion investigation and could not definitively conclude the root cause? If you are like most firms, this scenario was probably your most recent experience, happens quite often, and frankly, is probably completely unnecessary. Most excursions are usually caused by self-inflicted phenomena. This presentation will discuss the most common causes of microbial excursions in water systems and how they can easily be avoided with minimal effort. Just think of the resources, production downtime, product losses, and cost you could save by making a few rational changes to your action "trigger values", sampling and testing, while still being able to (more clearly now) see real system problems when they do occur. You simply cannot afford to not tune in to this valuable webinar!
Areas Covered in the Session:
Who Will Benefit:
- What are excursions?
- Water system dilemma: process control or quality control (utility or raw material), or both
- Intended functions of Alert/Action Levels and Specifications
- Investigation, necessary and often fruitless
- Excursion responses and impact
- Criticality of valves, hoses, & outlet flushing
- Diagnosing the source of the problem
- Minimizing unnecessary excursion responses through best practices
- QA managers and personnel involved in investigations of excursions and preparing CAPAs
- QC managers and personnel involved in sampling, testing, and trending chem and micro data from water systems
- Utility operators and their managers involved in maintaining and sanitizing water systems
- Validation Managers and Personnel
- QA Managers and other Personnel involved in Change Control programs
- QA Managers and Regulatory Affairs personnel involved in defending water system operations and Quality Data to FDA and EMEA Inspectors and outside Auditors
- Consultants and Troubleshooters
T.C. Soliis a Ph.D. Microbiologist and President of Soli Pharma Solutions, Inc. and for the past 16 years has offered troubleshooting consulting and training services covering water systems, sterilization, sterile and non-sterile manufacturing, microbiological laboratories, and microbial and beta-lactam contamination control. He has 42 years of pharmaceutical experience as a consultant and with operating companies including DSM Pharmaceuticals, Catalytica Pharmaceuticals, Glaxo Wellcome, Burroughs Wellcome, and Pfizer.
He has served the past 20 years as a member of USP Expert Committees responsible for everything related to high purity water in USP/NF. He continues to serve USP with his water expertise in the role of Expert Advisor. He is an Approved USP Instructor, and in addition to this Pharmaceutical Water course, has given multiple webinars for Compliance4All as well as the USP Education Department. He previously served for 18 years on the PhRMA Water Quality Committee whose achievements included creating the Water Conductivity and TOC specifications used in USP Purified Water and Water for Injection since 1996 (USP 23, Supplement 5) and since adopted world-wide.
Dr. Soli is a recognized global expert consultant, speaker, and trainer in contamination and biofilm control in the Biopharmaceutical, Medical Device, Personal Care Product, and Beverage Industries and has coauthored numerous articles in Pharmacopeial Forum, Pharmaceutical Engineering, and Pharmaceutical Technology, as well as other publications and has authored chapters in many books and industry guides published by PDA and ISPE.