Implementation of Rapid Microbial Methods for Air and Water Monitoring in Pharmaceutical Industry

Why Should You Attend:

If you are a professional who is involved in planning, design, purchase, qualification, validation and continuous lifecycle of rapid microbial detection instruments in purified water systems, this webinar will demystify an entire lifecycle risk-based approach to installation and validation of the new and exciting method of microbial detection which will allow you to assess microbial water quality instantaneously and continuously.

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 meets compendial specification. In addition, it will offer regulatory view on implementation of rapid microbial detection instruments.

Learning Objectives:

• Dispel mistaken paradigms regarding the risk based approach to introduction of rapid microbial detection systems for water systems.
• Understand how LIF works and detects bioburden.
• Understand how to validate and transfer LIF method.
• Learn how to validate LIF instrument against currently used methods.

Areas Covered in the Webinar:

• Risk Based Approach
• Design of Water Systems
• Qualification of Water Systems
• Laser Induced Fluorescence as a Sample of Rapid Microbial Testing Instrumentation
• Principals and History of LIF
• Microbial Cell Structure
• Basics of an Instrument Operation
• Method Validation
• Method Transfer
• Performance Qualification
• Sampling Schemes
• Data Analysis
• Continued Verification

Who Will Benefit:

This webinar will be useful at levels from senior management to those involved in operation of water systems on a day-to-day 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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