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Out of ignorance, it is too easy to over-react with numerous activities only to find that the problem returns because the root cause was not squarely addressed. Frankly, the skill to find the true root causes and solve these sometimes very complex problems is usually learned from experience using a thorough understanding of biofilm, awareness of good (and bad) manufacturing and laboratory practices, an understanding of human nature, and healthy doses of curiosity, persistence, and common sense. This webinar will jump-start your investigative skills with tips on the investigation elements used by the author, some of the pitfalls and red herrings that will be encountered, and some actual (but anonymous) case studies where the author has resolved problems that may not be too different from some with which you may have struggled.
Why Should You Attend: Have you ever encountered what appeared to be a water system problem or worse, a product contaminated with a water-type organism? If so, you already know there is no rule book on how to find the root cause and resolve the problem. However, you can take some pointers from a consultant who makes a living doing this very thing and see some intriguing case studies where his approach was used to resolve the problems. If you are involved in these kinds of investigations and problem-solving, you can't afford to miss this webinar.
Areas Covered in the Session:
- Gathering and assessing existing data and symptoms
- Considering user opinions
- Investigation approach elements
- Recognizing red herrings and false positives
- Recognizing possible root causes
- Water system/product contamination case studies
- Seven kernels of water system investigation wisdom
Who Will Benefit: This webinar will be valuable for all companies that operate non-compendial deionized water systems as well as WFI or Purified Water systems, particularly for those in FDA and EMA regulated industries, including Medical Devices, Diagnostics, Pharmaceutical APIs and Dosage Forms, Biologics, consumer products, and cosmetics companies. The specific job functions that 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