Validation of Purified Water Systems

Why Should You Attend:

This webinar will benefit professionals involved in planning, design, purchase, qualification, validation and continuous lifecycle of purified water systems. This session will demystify an entire lifecycle risk-based approach to validation of this vital utility as well as critical pharmaceutical component. In the age when regulators expect from pharmaceutical industry risk-based decisions, this webinar is a must for those professionals who are responsible for seamless non-stop operation of water system that continuously meet compendial specification. In addition, the course will review case studies from recent regulatory observations which will help participants learn from other companies’ shortcomings.

Learning Objectives:

• Dispel mistaken paradigms regarding the risk based approach to water system lifecycle.
• Understand how to eliminate variability – the cause of most deviations.
• Understand how to best deliver water from a high purity water distribution system.
• Capitalize on the advantages of on-line analytical instrumentation (chemical and microbiological rapid methods).
• Understand what it would take to transition to Real-Time Release of water.

Areas Covered in the Webinar:

• Risk Based Approach
• Design of Water Systems
• Installation Qualification Concept
• Operation Qualification – What is Involved
• Performance Qualification
• Sampling Schemes
• Data Analysis
• Continued Verification

Who Will Benefit:

This information would be useful at levels from senior management to those involved in operation of water systems on day-today basis. It would be valuable for experience levels ranging from seasoned veterans to those newly assigned to roles related to water:

• Quality Assurance/ Quality Control (Chemistry and Micro)
• Process and Design Engineering
• Process Automation
• Manufacturing Operations
• Validation
• Utility Operations
• Regulatory Affairs

Instructor Profile:

Igor Gorsky has been a pharmaceutical industry professional for over 30 years. He held multiple positions with increasing responsibility at Alpharma, Wyeth and Shire. He worked in production, quality assurance, technical services and validation including as an associate director of global pharmaceutical technology at Shire Pharmaceuticals.

He currently holds the position of senior consultant at ConcordiaValsource, LLC. His accomplishments over the years include validation of all aspects of pharmaceutical and biotechnology production and quality management, technical support of multi-billion dollar drug product lines and introduction of new products into the market. He has published articles and white papers in pharmaceutical professional magazines and textbooks. In addition, he had been a presenter at Interphex. He is also very active with PDA participating in several task force groups authoring PDA Technical Reports 29 (Points to Consider for Cleaning Validation) and 60 (Process Validation). He leads a PDA Water Interest Group. He holds a BS degree in mechanical and electrical engineering technology from the Rochester Institute of Technology.

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