New Pharma Water System Project Details
- Speaker:Peter T. Vishton, P.E
- Date: 18th October 2018 10:00 AM PST | 01:00 PM EST
- Product Code:GRC-90397
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GRCTS Attendance Certificate
All Pharma Water systems have FDA established Standards for drug manufacturing. Included are Chemical and Microbial limits, Sampling, Testing, Materials, Records, Reports, Instruments, Calibrations, Drawings, Schematic Diagrams, Monitoring, SOPs, Quality by Design, Risk Assessment, Commissioning, Validation and others.
This Seminar will cover “ALL” of these as well as other details of acquiring and installation of a Pharma Water System to meet FDA expectations. It can also be used as a guide for existing systems upgrades.
Areas We Will Be Covering:
- Pharma Water Systems Essential Terminology
- Feed Water Characterization and Changes
- Base Water Chemistry
- Water Qualities required by FDA, EU, others
- Pharmacopeia Water Grades / Purified, WFI, Distillation – VC and ME
- System Pre-Treatment Components
- Final Treatment Components
- Point of Use Valves
- Control Systems / Data Collection
- SOPs / Writing /Training
- Understanding and Resolving System Deviations
- Calibration / Maintenance
- As- Built Documentation
- Regulatory Inspection Issues
- Typical Systems
Who Will Benefit:
- Most Pharmaceutical employees should benefit from this wide-ranging presentation.
- All Pharmaceutical Products personnel that have some involvement with Pharma Water Systems.
- All Pharmaceutical Products require water meeting specifications to make products that the FDA will permit their sale.
- Quality employees
- Sample Analyzers
- End Users
- Project Managers and others.
Peter T. Vishton, P.E.
Subject Matter Expert Pharma Water & GMP Utility Systems
Peter Vishton currently is an Independent Consultant supporting Pharmaceutical Companies to keep their Pharma Water Systems functioning very well. The types of problems that these Systems experience can be difficult to determine and correct quickly. Peter has been a member of the ISPE teams that have written and published several Good Practice Guides for Pharma Water Systems and GMP Utilities. As a result, his experience with Pharma Water Systems is very wide. He has been directly involved in almost all the steps that have to take place to install and operate a Compliant New Pharma Water System that meets all requirements. This presentation will cover these steps and requirements.