If there is one reason for which laboratories, utility operations, and production have to invest huge expenditures and effort on items such as labor for system sanitization and additional testing and quarantines of whole systems or specific outlets; it has to be water system microbial excursions. Poorly executed water system microbial excursions can also lead to losses when they invite investigations and can also lead to potential costs associated with product rejections where root causes are not definitive.
While it is true that some excursions are genuine and result from system control problems, most are usually self-inflicted. They can be caused by factors such as poorly designated “trigger values”, badly designed use points, or poorly executed sampling or testing. How do pharmaceutical water systems organizations overcome issues such as this?
The ways of doing this will be taught at a 90-minute webinar that Compliance4All, a leading provider of professional training for all the areas of regulatory compliance, is organizing on April 16. The guru of pharmaceutical water systems, Teri C. Soli, will be the speaker at this important presentation. Please log on to https://t2m.io/itHNR1Od to enroll for this webinar.
The core learning that this webinar will impart will help participants explore the possible causes, including the symptoms of real, as well as false, water system problems, and will provide effective alternatives to avoiding most of their current superfluous excursions. It will show them how to build supporting data that will become useful in pinpointing causes when investigations are indeed necessary.
Dr. Soli will help participants understand the most common causes of microbial excursions in water systems and how they can easily be avoided with minimal effort. He will cover the following areas at this 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.
This webinar is of immense value to:
- 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.
About the speaker: Dr. Teri C. Soli is a microbiologist and President of Soli Pharma Solutions, Inc., which offers troubleshooting and training expertise covering water systems, sterilization, sterile and non-sterile manufacturing, microbiological laboratories, and microbial and beta-lactam contamination control.
Dr. Soli is a recognized global expert in contamination and biofilm control in the biopharmaceutical, medical device, and personal care product industries. He has authored numerous articles in Pharmacopeial Forum, Pharmaceutical Engineering, and Pharmaceutical Technology and other publications, and has authored chapters in many books and industry guides published by PDA and ISPE.