Overview: It is an unfortunate fact that most water systems today have been designed and are operated and controlled using at least some traditional concepts and methods that are downright wrong.

So how could such traditions become so ingrained and be so wrong? How could well-intentioned benchmarking be so misguided? There are many reasons, which will be discussed, but regardless of the causes, we need to be aware of these myths and understand how it really should be done. A number of water system myths will be discussed that are related to microbial control approaches as well as microbial monitoring. Each myth will be explained as to its origin and then put into true context with how the supposed microbial control or monitoring approach SHOULD be handled. You will probably be surprised to learn which of your "rules of thumb" are actually quite wrong!

Areas Covered in the Session:

• Why water myths develop
  
• Impact of c-GMPs
• Well-meaning but misguided precedents
• Scientifically unchallenged traditions and benchmarking
• Rule-hungry culture
• Water System Microbial Control Myths
  
• WFI from RO
• Turbulent Flow and Flow Rate
• Dead Leg Rules
• Smooth Surfaces
• In-Line Sterilizing Filters
• Ozone
• Microbial Enumeration Myths
  
• Referee Methods
• Thermophiles in Hot Systems
• R2A, 35°C, 5 days
• Test Filter Membrane Rating
• Compendial Action Levels
• TOC and Endotoxin as Microbial Count Correlates

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
  
• Engineers involved in water system design and installation
  
• 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 laboratory managers and personnel involved in sampling, testing, and trending chem and micro data from water systems
  
• Consultants and Troubleshooters

Overview: The Microbiology Lab must take leadership in contamination control support for production because it is the hub of the necessary technical expertise.

This broad manufacturing support role covers many areas, including routine raw material and product testing, disinfectant/sanitant qualification, water and compressed gas testing, environmental monitoring, microbiological “awareness training� of production operators, etc. Perhaps their most difficult leadership role is in contamination control investigations where product is at risk, manufacturing may be at a standstill, and the pressure to resume operation with a quick (and possibly incorrect) fix is tremendous. In these situations, the microbiology lab can either gain or lose credibility in the eyes of manufacturing management depending on the timeliness of its success in discovering and resolving the problems. This presentation will discuss these roles and how the lab can assure these activities are performed in a manner that facilitates root cause excursion investigations and avoids the lab or its personnel becoming the inadvertent cause of the excursions.

Why Should You Attend:
Someone must spearhead the effort to control a manufacturing site's microbial contamination issues. Though it typically is QA's responsibility to "assure" that production has no facility, raw material, or process contamination that could lead to product contamination, QA is not typically staffed by microbiologists who truly understand all the issues with this aspect of quality assurance. Therefore, it naturally should fall to the microbiology lab to take a lead role since likely no one else at the site has that expertise or is so intimately involved in the contamination assessment testing. Those supervising and doing this testing have a crucial role in the site's microbiological condition. They must be more than a data mill -- they must also interpret the data, even when not asked to do so. In spite of the logical role the Micro Lab can serve in proactively controlling microbial contamination on-site, there are often many impediments to their being able to assume this role. They are not insurmountable, but they must be overcome for the Labs to be able to help. Don't miss this webinar if you want to better understand how the micro lab can be more effectively utilized to prevent or head off microbial contamination issues as well as effectively resolve such problems should they have already occurred.

Areas Covered in the Session:

• How contamination is controlled
  
• Why the microbiology lab should lead in contamination control
  
• Routine contamination evaluation activities
  
• Microbiological training
  
• Root cause and impact investigations
  
• Impediments to leadership
  
• Observed contamination correlations & doing the right thing

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 Regulatory Affairs personnel involved in defending water system operations and quality data to FDA and EMEA inspectors and outside auditors
  
• Consultants and Troubleshooters

Overview: Though hardly a water system is designed and installed without some capability of sanitization, the system design features, materials of construction, sanitization chemical choices and how they are used, as well as the frequency of the sanitization process have everything to do with its success.

This presentation focuses on the factors that can lead to water system sanitization success as well as failure so that the user can not only devise workable sanitization approaches, but also be able to recognize the early symptoms of a sanitization failure and troubleshoot the process for better optimization.

Areas Covered in the Session:

• Understand the basic water system sanitization concepts
  
• Use this understanding to design effective microbial control measures for your water systems
  
• Use this understanding to solve microbial problems originating from poor sanitization practices
  
• Debunk a few water system myths related to sanitization

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:

• Engineers involved in water system design
  
• Utility operators and their managers involved in maintaining and sanitizing 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