FDA - Is Your cGMP Water System Ready for their Visit?
This course will explain how to enable the cGMP Pharmaceutical Water Systems work to be accomplished quickly and properly, with minimum delays. This course will also cover the items and procedures that are required to accomplish everything that will help approve the pharmaceutical water system and place it in use.
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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.
This course will cover the items and procedures that are required to accomplish the items listed above that will enable the pharmaceutical water system to be approved and placed in use.
Another requirement is expertise in instrumentation and automation.
Good Practices for Pharma Water Systems that will prevent problems will be presented.
Why should you Attend:
cGMP Water Systems require numerous steps to be ready for their Assembly, Testing, Commissioning, Validation and Approval for cGMP use. These steps require previous experience to be accomplished properly.
If "ALL" the FDA procedures are not included and recorded in GMP Water Systems Commissioning and Validation the way the FDA anticipates, the Approval of the System and its use can be delayed. Sections of the work and documentation may require repeating steps of the work, explanations of how the work was done, additional time and costs before being placed into use.
This course will cover the details that will enable the work to be accomplished quickly and properly with minimum delays.
Areas Covered in the Session:
Who Will Benefit:
- 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
- Analysis of Pharma Water Systems Commissioning and Validation potential problem areas
- 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 EMA 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
- Suppliers of Water System Equipment
- Suppliers of Water System Sanitization Processes and Chemicals
- Suppliers of Microbial Testing Equipment and Growth Media
- Consultants and Troubleshooters
Peter Vishton P.E. is an ISPE SME of Pharma Water Systems. He is an Independent Pharmaceutical Water Systems Consultant supporting several companies. He completed his Bachelor's and Master's Degrees from Drexel University. He has 25 years of experience in Pharma including 10 years with Pharma Water Systems.
His experience includes being a member of GMP Teams to Design / Construct / Start Up /Commission and Qualify new or expanded cGMP pharmaceutical facilities. Included were Production spaces, Manufacturing Equipment, Utilities and their Control Systems. Among the assignments were R&D, Parenterals, Biologics and OSD.
Peter is an active ISPE member that participates in current and new technology publications and forums assuring current knowledge of industry practices in GMP Manufacturing, Clean Utilities, Quality and FDA guidance. He has been a contributing author on all the ISPE Communities of Practice Publications for GMP Pharmaceutical Water, Steam and Compressed Gasses where he worked with Industry Experts.