Understanding and Effectively Controlling Biofilm in Pharmaceutical Water Systems

April 13, 2011 - PRLog -- This interactive one-day course provides a thorough understanding of what makes water systems have microbial problems with proven solutions for microbial control.  It also details how to validate that control by determining the operations and processes that logically must be evaluated in pharmaceutical water and steam systems during the validation exercise in a manner that will please FDA.

Finally, and perhaps most importantly, attendees will learn how to institute simple sampling, monitoring and microbial control levels that will dramatically reduce microbial excursions and facilitate having successful and accurate root cause investigation outcomes.

In short, if your job brings you in contact with any aspect of water system design, maintenance, trend monitoring, sampling, testing, sanitization, validation, responses to microbial excursions, root cause investigations, or regulatory interactions, you cannot afford to miss this invaluable training as well as the tips, tricks, and kernels of wisdom that this all-day webinar will give you.

Duration:

6 hours of instruction, one hour lunch, and short breaks as they fit into the schedule.

Agenda (times Eastern)

- 10:00am (7am Pacific)-11:30 Module 1: Biofilm: Understanding What Makes Water Systems Have Microbial Problems (1:30)
- 11:30-1:00pm Module 2: Successful Sanitization and Microbial Control Approaches for  Pharmaceutical Water Systems (1:30)
- 1:00-2:00 Lunch hour
- 2:00-3:30 Module 3: Logical and Rational Water and Steam System Validation (1:30)
- 3:30-3:45 Afternoon break
- 3:45-5:15 Module 4: Reducing Microbial Excursions and Improving Investigation Outcomes (1:30)
- 5:15-5:30 Q&A

Who Will Benefit:

- Engineers responsible for water system design and fabrication
- Maintenance personnel responsible for water system maintenance and sanitization
- Microbiological personnel involved in collecting and testing water system samples
- Validation personnel involved in writing and executing water system validation protocols
- Quality Assurance professionals involved in deviation investigations and - oversight/approval of all other water system activities as well as those involved in defending - water system issues to regulatory investigators who may or may not be water experts themselves
- Regulatory Affairs professionals involved in describing water and water systems in - regulatory filings and also those involved with regulatory inspections
- Managers and supervisors of all these disciplines who need to understand what makes - water systems unique design, control, monitoring, validation, and investigative challenges.

Instructor Profile:

T.C. Soli, Ph.D. is President of Soli Pharma Solutions, Inc, with lecturing, auditing, and troubleshooting expertise covering water systems, sterilization, aseptic processing, contamination control, and microbiological laboratories. He has over 31 years of pharmaceutical experience as a consultant and with DSM Pharmaceuticals, Glaxo Wellcome, Burroughs Wellcome, and Pfizer. Dr. Soli’s career-long water systems and contamination troubleshooting, coupled with water-related USP, ISPE, PhRMA, and PDA committee involvements, afford him practical knowledge about process and contamination control; cleaning, sterilization and process validation; and all aspects of high purity water systems

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