2-day In-person Seminar on “Mastering Biofilm Control, Monitoring, Validation and Excursion Investigations of Pharmaceutical Water Systems” at Anaheim

Overview:

This course is designed to provide a microbiology-focused education about all aspects of water systems and how Biofilm manages to thrive there. Prior microbiological education or training, though a plus, is not necessary. The instructor can provide the background needed to understand this very important subject matter. This understanding is essential for the proper design, validation, operation, monitoring, and maintenance of a high purity water system. Without this understanding, water system design and control are merely managed by a set of rules that often don't work and can cause very costly system downtime or even product recalls. 

Why you should attend:

Are you having persistent water system problems - nothing you do seems to help for very long if at all? Are your water systems excursion investigations always inconclusive because you can never confirm the original out-of-limit result and the bad results come and go? Are you concerned that FDA will not think your water system validation was not stringent enough because of your current microbial problems? Are you afraid that Biofilm has taken over and you can't get rid of it? 

These are common concerns that primarily originate out of ignorance of appropriate design, maintenance, sanitization, sampling, and testing for your water system. Attending this two-day course will open your eyes to what is really going on in your water system and how to "get it right", finally! Can you afford to remain ignorant and repeat the problems of the past or should you attend this course to replace that ignorance with the knowledge that will allow you to get the water system under control.

Course Outline:

Day 1 – Agenda

Lecture 1: Controlling Water System Biofilm Through Design & Operation

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

Lecture 3: Water System Validation by Logic Instead of Tradition

Lecture 4: Understanding and Controlling Endotoxin

Lecture 5: Harmonizing vs. Optimizing Water Microbial Testing for System Quality Control

Day 2– Agenda

Lecture 6: Microbial Enumeration Issues with High Purity Water Systems

Lecture 7: Reducing Water Microbial Excursions & Improving Investigations

Lecture 8: Water System Investigation "How-To's" and Example Case Studies

Lecture 9: The Hero of Manufacturing Contamination Control: The Microbiology Lab

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

Who Will Benefit:

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, troubleshooting, and excursion mitigation
5. Facility Engineers responsible for water system design or renovation
6. Validation personnel for water system qualification

About Speaker - 

Dr. T.C. Soli is a Ph.D. Microbiologist and President of Soli Pharma Solutions, Inc. (www.solipharmasol.com), and since becoming a full time consultant, has served consumer products and FDA-regulated industries with training and troubleshooting expertise. 

The areas he has covered include water systems, sterilization, aseptic processing, microbiological and beta-lactam contamination control and microbiological laboratory operations. Soli has also served as a pharmaceutical expert witness in several "contamination" litigations.