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.
GMP Purified Water Systems
Product ID: 506526
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.

Areas Covered
  • 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
Topic Background
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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Instructor Profile:
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.
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