FDA – Is Your cGMP Water System Ready for their Visit?

cGMP pharmaceutical water systems require specific Design, Documentation, Manufacturing, Installation, Testing, Commissioning, Start Up, Validation, Quality Testing and Extended Operation to become available for pharmaceutical manufacturing of products for sale.

Many steps and processes go into making cGMP water systems ready for their Assembly, Testing, Commissioning, Validation and Approval for cGMP use. Undoubtedly, implementing these steps properly requires previous experience and expertise in instrumentation and automation.

A 90-minute webinar from Compliance4All, a leading provider of professional training for all the areas of regulatory compliance, will show how to obtain a proper pharmaceutical water systems cGMP that will help the water systems company face an FDA visit with confidence and pass its inspection.

Peter VIshton P.E., a senior an independent pharmaceutical water systems consultant who supports several companies with their water systems, will be the expert at this session. Please join the learning experience by logging on to

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At this webinar, Peter will explain what all items and procedures are required to accomplish items such as specific Design, Documentation, Manufacturing, Installation, Testing, Commissioning, Start Up, Validation, Quality Testing and Extended Operation, which will enable the pharmaceutical water system to be approved and placed in use. He will also familiarize participants with good practices for pharma water systems that will prevent problems.

If any of these items are missing or are not included and recorded in in GMP Water Systems Commissioning and Validation in a manner the FDA expects, it could delay its approval and use. For pharma water systems to avoid this scenario, it may sometimes become necessary to repeat the steps of the work and its documentation and adding explanations of how the work was done. All these iterations are sure to cost the organization more time and resources. Yet, the cost of noncompliance is inestimably higher than these.

At this session, the expert will show how to meet the FDA’s requirements and expectations and avoid getting penalized for noncompliance. He will cover the following areas:

• Pharmaceutical Water Systems basics
• Equipment that is commonly used to produce Purified Water and WFI
• The Basic Regulatory Standards for chemistry and biological levels of Purified Water and WFI
• The STEPS required to meet FDA Commissioning and Validation of Pharma Water Systems to assure Compliance
• Documentation required to meet FDA Commissioning and Validation of Pharma Water Systems
• Examples of potential PROBLEMS that can cause a System to not meet FDA Compliance
• Dead Leg Rules
• Compendial Action Levels of Purified Water
• Sections of the ISPE "Approaches to Commissioning and Qualification of Pharmaceutical Water and Steam Systems" Good Practice Guide will be referenced
• Methods to correct Pharma Water Systems Commissioning and Validation potential problem areas
• Good Practices for Pharma Water Systems that will prevent problems
• Pharma Water Systems practices that the FDA expects Pharmaceutical Water Systems potential impact to Regulatory drug manufacturing

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Compliance4All is a professional trainings provider for the regulated industries. It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations.