Pharmaceutical Water Use and Monitoring

Why Should You Attend:

If you are a professional who is involved in the day-to-day maintenance, monitoring, sampling, testing, usage, and trending of continuous lifecycle data from pharmaceutical purified water systems, this webinar is definitely for you. During this session, the instructor will discuss purified water systems use throughout their entire lifecycle. The program will concentrate on a risk based approach to use and monitor water systems and all their components. Differences between FDA and EMA purified water standards will also be discussed along with recommendations for global applications.

In the age where 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, it will review case studies from recent regulatory observations which will help participants learn from other companies’ shortcomings.

Learning Objectives:

• Understand purpose and significance of sampling.
• Understand how to eliminate sampling variability – the cause of most deviations.
• Understand how to best deliver water from a high purity water distribution system.
• Capitalize on the advantages of online analytical instrumentation.
• Understand the value of rapid microbiological methods.
• Understand real-time release of water.
• Learn how we can explore achievements in water use and monitoring from other industries.

Areas Covered in the Webinar:

• Risk Based Approach
• Design of Water Systems
• Sampling Schemes
• Data Analysis
• Continued Verification

Who Will Benefit:

This webinar is targeted toward the following organizational positions and disciplines. It will be discussed in a pragmatic and practical understandable language by all technically educated or trained professional. This information would be useful at levels from senior management to those who are 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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