GMP Purified Water Systems - What You Should Know About Water Systems Before Typical Problems Occur
Duration: 90 Minutes
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Presented initially are the basic equipment components of a Purified Water and WFI water generation system. This leads to common and some less common problems that will occur in these systems that can impact the required Quality of the water for use. The potential solutions and their prevention in the future will then be covered. These problems are based on numerous Case Studies, magazine articles, Water Systems Guides and actual experience with the Water Systems.
02/09/2018 11:30 AM02/09/2018 05:30 PMTraining Topic: GMP Purified Water Systems - What You Should Know About Water Systems Before Typical Problems OccurInstructor: Peter T. Vishton, P.E.
Objectives of the Presentation
Basic production steps of Purified and WFI Water
Equipment components of Purified and WFI Water
Basic Regulatory Standards of Purified and WFI Water
Anticipated common problems of these Water Systems that can cause them to not meet Regulatory Requirements
Potential methods to correct the problems
Potential prevention methods of the problems
Why Should you Attend
People working in the Pharmaceutical Manufacturing Industry and using the Pharma Grade Water must be knowledgeable of the Regulated Water meeting USP and FDA Standards. Only understanding the operation of these Water Systems enables personnel to be aware of problems and their potential impacts on drug products manufacturing required Quality.
Pharmaceutical Water Systems basics
Pharmaceutical Water Systems potential impact to Regulatory drug manufacturing
Analysis of Pharma Water problems
Methods to correct Pharma Water problems
Good Practices for Pharma Water Systems that will prevent problems
Pharma Water Systems practices that the FDA expects
Who will Benefit
Facilities Engineers responsible for GMP manufacturing areas and GMP Utilities
Maintenance personnel who maintain GMP Utilities like Water Systems
Pharma Manufacturing Managers who require Pharma Water to produce drug products
Quality personnel required to test and certify Pharma Water
Pharma Research personnel who require Pharma Water
All Pharma Manufacturing requires Pharma water meeting FDA and Regulatory Standards. Pharma Drug manufacturing failing to meet Water Standards stops Manufacturing until resolved. This presentation presents Standards for Pharma Water and common problem's correction.
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Peter is an Independent Pharmaceutical Water Systems Consultant supporting several companies. He completed his Bachelor's and Master'sDegrees 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.