Webinars Series on Water System Compliance for Consumer Products, Medical Devices, Diagnostics, Pharmaceuticals, and Biologics

Water can be a major source of microbial contamination in the manufacturing systems for Medical Devices, Diagnostics, Pharmaceuticals, and Biologics fields, as well as consumer products and cosmetics companies. There are many standards proposed by different associations and industry bodies related to different aspects of water system compliance. Some of these are quite dated and may, frankly, contain inaccurate information. Until now with ComplianceOnline, accurate and current information could not be found from a single resource. Companies need to know the most current, accurate information on how to control, monitor, validate, and respond to deviations in their water systems in order to stay in compliance.

Attend this series of webinars to listen Dr. T.C.Soli talk about these various aspects of water systems in order to better assure your water system compliance.

Part 1:

What Makes Water Systems Have Microbial Quality Problems

This Water System Compliance training will review what biofilm is and how it grows.It will cover how biofilm affects just about every kind of unit operation used in today's water systems.

Areas Covered in the Webinar:

• 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 microbial control myths.
• Get answers to your own water system questions.

Who Will Benefit:

This webinar will be valuable for all companies that operate high purity water systems, particularly for those in FDA and EMEA regulated industries, including Medical Devices, Diagnostics, Pharmaceuticals, and Biologics fields, as well as consumer products and cosmetics companies.The employees who will benefit include:

• Engineers involved in water system design.
• Utility operators and their managers involved in maintaining water systems.
• QA managers and personnel involved in establishing water quality specifications and process control (Alert and Action) levels.
• QA managers and personnel involved in investigations of excursions and preparing CAPAs.
• QC managers and personnel involved in sampling, testing, and trending chem and micro data from water systems.
• Validation managers and personnel.
• Consultants and troubleshooters.

Part 2:

Harmonizing Water Microbial Testing for Optimal Quality Control

This Water System Compliance training/webinar covers the reasons for diverse types of flora from one type of water to the next, the differences in the compendial water test methods, the advantages and disadvantages of harmonization, and how to optimize your microbial test methods for the flora in your particular water systems.

Areas Covered in the Webinar:

• Water harmonization that has already occurred.
• Water Micro Test Method “Dis-Harmonization”.
• Biofilm basics and how it develops.
• Biofilm diversity in water systems.
• Micro Test Method options and evaluation protocol.
• The good and bad of Micro Test Method harmonization.
• Where Rapid Micro Methods can fit in.

Who Will Benefit:

This webinar will be valuable for all companies manufacturing Medical Devices, Diagnostics, Pharmaceuticals, and Biologics as well as consumer products and cosmetics whose laboratories utilize pharmacopoeial test methods for water system testing.The employees who will benefit include:

• Microbiology analysts who perform water testing.
• Microbiology laboratory supervisors and their managers.
• QA managers and personnel involved in establishing methods and specifications for water testing.
• Regulatory Affairs managers and personnel involved in defending laboratory operations to FDA and EMEA inspectors and outside auditors.
• Validation managers and specialists who must specify test functions and acceptance criteria for water system validation programs.
• Consultants.

Part 3:

Understanding and Controlling Endotoxin

This Water System Compliance training covers where endotoxin can come from in the water system, how to control those sources, how it behaves in pure water, how the trace level tests for it work, and how to "clean up" endotoxin once it has contaminated water, APIs, or equipment. All these issues and more will be addressed so that the attendee can have a better appreciation of the endotoxin test, and a better understanding of what can go wrong in WFI systems to allow endotoxin into the finished water.

Areas Covered in the Webinar:

• Where does endotoxin come from?
• What are the properties of endotoxin?
• How do you get rid of it?
• How do you detect it?
• What assay controls are used?
• What are the endotoxin specs for water?
• How do you control it?

Who Will Benefit:

This webinar will be valuable for all companies that operate WFI or "endotoxin-controlled"water systems, particularly for those in FDA and EMEA regulated industries, including Medical Devices, Diagnostics, Pharmaceuticals, and Biologics fields, as well as consumer products and cosmetics companies.The employees who will benefit include:

• Engineers involved in water system design.
• Utility operators and their managers involved in maintaining water systems.
• QA managers and personnel involved in establishing water quality specifications and process control (Alert and Action) levels.
• QA managers and personnel involved in investigations of excursions and preparing CAPAs.
• QC managers and personnel involved in sampling, testing, and trending chem and micro data from water systems.
• Validation managers and personnel.
• Consultants and troubleshooters.

Part 4:

Implementing Changes to a Validated System

This Water System Compliance training will guide you through the logical process needed to implement and qualify the inevitable changes that will be needed for a Validated Water system. The impact of issues such as process control levels, quality specifications, change control systems, and the microbiology of water systems will be covered so that user can make educated (rather than “templated”) decisions about how much qualification of these changes is truly necessary.

Areas Covered in the Webinar:

• Water process control levels and quality specifications and how they differ.
• 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.

Who Will Benefit:

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

• QA managers and other personnel involved in Change Control programs.
• 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 managers and personnel involved in sampling, testing, and trending chem and micro data from water systems.
• Validation managers and personnel.
• Consultants

Part 5:

Water System Validation by Logic Instead of Tradition

This Water System Compliance training will guide you how validation should be customized to your particular water system design and maintenance practices,and what operational elements should be included in the validation.

Areas Covered in the Webinar:

• 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?

Who Will Benefit:

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

• Validation managers and personnel
• QA managers and other personnel involved in Change Control programs
• 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 managers and personnel involved in sampling, testing, and trending chem and micro data from water systems
• Consultants

Part 6:

Reducing Water Microbial Excursions and Improving Investigations

This Water System Compliance training will discuss the most common causes of microbial excursions in water systems, how they can easily be avoided,and how investigations can be more definitive with revealing testing and sampling control data.

Areas Covered in the Webinar:

• What are excursions?
• Water system dilemma: process control or quality control (utility or raw material), or both.
• Intended functions 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.

Who Will Benefit:

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

• QA managers and personnel involved in investigations of excursions and preparing CAPAs
• QC managers and personnel involved in sampling, testing, and trending chem and micro data from water systems
• Utility operators and their managers involved in maintaining and sanitizing water systems
• Validation managers and personnel
• QA managers and other personnel involved in Change Control programs
• QA managers and Regulatory Affairs personnel involved in defending water system operations and quality data to FDA and EMEA inspectors and outside auditors
• Consultants

Panelist Profiles:
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 covering water systems, sterilization, aseptic processing, microbiological and beta-lactam contamination control, microbiological laboratory operations, and has served as a pharmaceutical expert witness in several "contamination" litigations. Prior to full time consulting, he had 25 years of diverse "Big Pharma" operating company experience.

During his 30 year career he has lectured extensively at conferences, authored numerous papers and recently written several book chapters related to water system microbiology for PDA and ISPE publications. He is currently Vice-Chair of the USP Pharmaceutical Waters Expert Committee through which he authored the complete rewrite of USP’s “pharmaceutical water bible”, Chapter <1231>.