Thursday 6th February, 2014
9:00am to 6:00pm
Lecture 1: What Makes Water Systems Have Microbial Quality Problems
•Understand biofilm basics and how it develops
•Understand the impact of biofilm on the commonly used purification unit operations
•Understand how various commonly used microbial control strategies work (or don't work) to control biofilm development
•Understand the how, where, and why of microbial monitoring, action levels, etc.
•Debunk a few water system myths
•Get answers to your own water system questions
Lecture 2: Successful Sanitization Approaches for Trouble-Free Water Quality
•Material and construction limitations
•Continuous vs intermittent sanitization
•The importance of biofilm removal
•How sanitants work (or don't work)
•When to sanitize
•Troubleshooting sanitization problems
Lecture 3: Water System Validation by Logic Instead of Tradition
•Why validate a water system?
•Basic ground rules for water systems before you validate them
•Micro Test Method "validation"
•Minimum validation expectations
•How to figure out what you should validate
•What happens after the honeymoon is over
•Is validation ever really over?
•Special considerations for lab water systems
•Are packaged waters a viable option?
Lecture 4: Implementing Changes to a Validated System
•Purpose of a Change Control program - a help, not a hindrance
•When is a change major vs minor, requiring full vs limited re-qualification?
•What about water use during re-qualifications?
•FDA validation expectations
•Reliance on logic and common sense and the disservice of precedent and paradigms
•Additional useful tips
Lecture 5: Reducing Water Microbial Excursions & Improving Investigations
•What are excursions?
•Water system dilemma: process control or quality control (utility or raw material), or both
•Intended roles of Alert/Action Levels and Specifications
•Investigation, necessary and often fruitless
•Excursion responses and impact
•Criticality of valves, hoses, & outlet flushing
•Diagnosing the source of the problem
•Minimizing unnecessary excursion responses through best practices
Principal Consultant, Soli Pharma Solutions
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.
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