ComplianceOnline

Remediating Pharmaceutical Water System Biofilm - What to Do After It Gets Ahead of You

Instructor: T.C Soli
Product ID: 702860
Training Level: Intermediate
  • Duration: 90 Min

recorded version

$229.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

$299.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556

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Read Frequently Asked Questions

This pharmaceutical water systems webinar training will discuss what you should do when your monitoring data tells you that you may have a significant biofilm problem. It covers how to verify that the data and your interpretation of the data are correct, as well as the location of the problem which gives you clues as to what caused the problem and its impact on manufacturing and product.

Why Should You Attend:

Unfortunately, the point when some personnel begin to think about the possibility of having biofilm is after it may have already gotten out of control. Any Gram negative microbial counts at all means you already have biofilm, but when counts approach your process control levels, it usually means that biofilm is rampant, thick and out of control. If it is not brought back under control quickly, it will get much worst.

This webinar will not only allow you to recognize when biofilm has gotten out of control, but also, very importantly, how to bring it back under control and assuring it has been effective. But these measures are generally very extreme and not something you would want to routinely execute. So finding and attacking the source of the problem will allow you to understand how to prevent it from recurring and having to go through these extreme mitigation efforts yet again.

This webinar also covers the extraordinary sanitization strategies you can use to kill and remove the biofilm, and importantly, verifying the success of your efforts. These efforts are far more involved than routine microbial controls, so effective prevention is far better and cheaper than mitigating it after it has gotten out of control.

Areas Covered in this Webinar:

  • Are you sure there is a problem?
  • What is the scope of the problem?
  • What caused the problem?
  • What can remediate the problem?
  • What can prevent its recurrence?
  • Are you sure it worked?
  • Prevention is far easier than remediation!
  • Who will Benefit:

    This webinar will be valuable for all companies that operate WFI or Purified Water systems, particularly for those in FDA and EMA regulated industries, including Pharmaceuticals, Biotech and Biologics fields, as well as consumer products and cosmetics companies. The employees who 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

    Instructor Profile:

    Dr. Teri C. ("T.C.") Soli ,Ph.D. is President of Soli Pharma Solutions, Inc, serving the Pharmaceutical, Biotech, Medical Device, Dialysis, Cosmetics and Personal Care Products and related equipment and instrument manufacturing industries with training, auditing, and troubleshooting expertise. He has over 32 years of combined pharmaceutical experience as a consultant as well as with operating companies such as DSM Pharmaceuticals, Glaxo Wellcome, Burroughs Wellcome, and Pfizer. Dr. Soli’s career-long experience with water systems and product and process contamination troubleshooting, coupled with USP, ISPE, PhRMA, and PDA committee involvements, afford him practical knowledge and troubleshooting skills with contamination control, cleaning, sterilization, sterile and non-sterile processes, validation, laboratory testing, excursion investigations and all aspects of high purity water systems.

    He is in his third 5 year term on USP Expert Committees responsible for Pharmaceutical Water, is the author of USP’s Informational Chapter <1231> on pharmaceutical water, and helped develop the Water Conductivity and TOC specifications used by USP and adopted world-wide. He has motivated many audiences and course attendees with practical water system information. He has also authored many articles and chapters in books and industry standards published by PDA and ISPE including chapter authorships in the 2nd ed. ISPE Baseline Guide for Water and Steam Systems, ISPE’s Good Practice Guide: Ozone Sanitization of Pharmaceutical Water Systems, and chapters in several PDA books on pharmaceutical and laboratory water systems and biofilm control. He earned a Ph.D. degree in Microbiology and Immunology from the University of Arizona and M.S. and B.S. degrees in Microbiology from Texas A&M University.

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