Aside from being mentored by a "master", there is usually no problem-solving guidance available when it comes to solving water system contamination problems or product contaminations that appear to have been caused by the water system. 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:
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
T.C. Soli, is a Ph.D. Microbiologist and President of Soli Pharma Solutions, Inc. (www.solipharmasol.com), and is a consultant serving consumer products and FDA-regulated industries with training and contamination troubleshooting expertise covering water systems, sterile and non-sterile products and processes, and microbiological laboratory operations. Prior to full time consulting starting in 2004, he had 25 years of pharmaceutical operating company experience.
Event Link - http://bit.ly/1ahG9Vd