Overview: 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.
Areas Covered in the Session:
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
Who Will Benefit:
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
T.C. Soli, is a Ph.D. Microbiologist and President of Soli Pharma Solutions, Inc. (www.solipharmasol.com), and since becoming a full time consultant, has served consumer products and FDA-regulated industries with training and troubleshooting expertise covering water systems, sterilization, aseptic processing, microbiological and beta-lactam contamination control, microbiological laboratory operations, and has served as a pharmaceutical expert witness in several "contamination" litigations.
GlobalCompliancePanel is a training source that delivers diverse, high quality regulatory & compliance trainings. These trainings are simple while being relevant and cost-effective while being convenient.\r\n\r\nGlobalCompliancePanel imparts knowledge of best practices across a broad range of user-friendly mediums such as webinars, seminars, conferences and tailored, individualized consulting. These help organizations and professionals implement compliance programs that meet regulatory demands and put business processes in place.