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A to Zs of Microbial ControlMonitoringValidation and Troubleshooting of Pharmaceutical Water system

2/3/2014 9:00 AM - 2/4/2014 6:00 PM

Why you should attend:

Much fear and hype exists with pharmaceutical biofilms, especially those in water systems. Long term biofilm control cannot be achieved from a blind set of hand-me-down rules for design and operation. One must truly understand biofilm to be able to control it. And because every water system is unique, understanding how biofilm is trying to grow in your system, which could be different than any other system. This course will give you that understanding that is translatable to any system, so that uneventful microbial control is possible. Without this understanding you will quickly find that blind rules for operation (and design) eventually fail to work, and the consequences of failure will far exceed the educational costs that could have prevented it.

Who Will Benefit:

This 2-day course is particularly relevant to managers, supervisors, and operatives taking on new responsibilities related to water, but also for experienced water personnel to learn the "true" whys behind what they do and perhaps better ways of doing things. Specific positions that would benefit are:

1. Microbiology Laboratory supervisors and analysts responsible for water sampling and testing

2. Quality Assurance personnel responsible for water system deviation management and change control

3. Regulatory and Compliance professionals responsible for FDA interactions

4. Process and Utility Engineers responsible for water system maintenance, repairs, troubleshooting, and excursion mitigation

5. Facility Engineers responsible for water system design or renovation

6. Validation personnel for water system qualification

7. Change Control personnel involved in water system changes and repairs

8. Production Managers involved with water system use for manufacturing and cleaning

9. Laboratory Managers and Supervisors responsible for lab water systems and other water sources

Course Outline:

Day One

Lecture 1: What Makes Water Systems Have Microbial Quality Problems

Lecture 2: Successful Sanitization Approaches for Trouble-Free Water Quality

Lecture 3: Water System Validation by Logic Instead of Tradition

Lecture 4: Implementing Changes to a Validated System

Lecture 5: Reducing Water Microbial Excursions & Improving Investigations

Day Two

Lecture 6: Understanding and Controlling Endotoxin

Lecture 7: Harmonizing vs Optimizing Water Microbial Testing for System Quality Control

Lecture 8: Microbial Enumeration Issues with High Purity Water Systems

Lecture 9: Water System Investigation "How-To's" and Example Case Studies

Lecture 10: What USP Does and Doesn't Say about PW, WFI, Pure Steam and Micro Issues

Speaker Profile:

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.

Location: Dubai, UAE

Date: 3rd & 4th February 2014

Time: 9 AM to 6 PM


Contact Information:

John Robinson

Toll free: 1800 447 9407

Fax: 302 288 6884



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