Course offering number:0903-703
Course ID:
2260
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Pharmaceutical Water Systems: Validation and Start-Up
In Conjunction with Wiley-Blackwell
Pre-recorded Course
AN ON-DEMAND ONLINE TRAINING FORMAT
Who Should Attend
This course is intended for professionals in the Pharmaceutical and Biopharmaceutical Industries including:
• Engineers
• Quality Assurance
• Quality Control
• Facilities Managers
• Utility Managers
• Validation Professional
• Regulatory Affairs
Anyone responsible for designing, managing, sampling, operating, validating or regulatory affairs of compendial water systems will find this
training valuable. Participants ranging from those with little to no experience with water systems, to those with several years of experience
will benefit.
Description
Water is the single largest ingredient used in biopharmaceutical manufacturing, and permeates every aspect of biopharmaceutical
manufacturing. The uses of water, and steam derived from water, constitutes a major operational and quality issue in the industry on a worldwide
basis. As such, water is governed by specific requirements for quality and use. This 90-minute accredited training session will review
U.S. and international validation requirements, and define basic validation and start up protocols.
Module 1:
• Water System Validation Regulatory Requirements
• Validation Strategies
Module 2:
• IQ/OQ/PQ for Water Systems
• Water System Testing in PQ
Module 3:
• International Differences
• Design Qualification
• Start Up Protocols and Issues
Question and Answer Session