Validation of Purified Water Systems

Instructor: Igor Gorsky
Product ID: 704272
  • Duration: 150 Min

recorded version

$249.00 (89%)
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Last Recorded Date: Nov-2015

Training CD / USB Drive

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Read Frequently Asked Questions

This training program will dispel mistaken paradigms regarding the risk based approach to water system lifecycle. It will detail how to eliminate variability – the cause of most deviations. Attendees will learn how to capitalize on the advantages of online analytical instrumentation (chemical and microbiological rapid methods).

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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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email call +1-888-717-2436 (Toll Free).

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