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Validity : 19th Apr'24 to 29th Apr'24
Implementation of Rapid Microbial Methods for Air and Water Monitoring in Pharmaceutical industry
• 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
Overview of the webinar
This webinar will dispel mistaken paradigms regarding the risk-based approach to introduction of rapid microbial detection systems for water systems. It will help attendee to understand how LIF works and detects bioburden. We will also help attendee to understand how to validate and transfer LIF method and learn how to validate LIF instrument against currently used methods.
Who should attend?
This webinar would be useful at levels from senior management to those who are involved in the 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
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 is definitely for you. During this session we will demystify an entire lifecycle risk-based approach to installation and validation of this 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 meet compendial specification. In addition, we will regulatory view on implementation of rapid microbial detection instruments.
Faculty - Mr.Igor Gorsky
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 an Associate Director of Global Pharmaceutical Technology at Shire Pharmaceuticals. He is currently holding a position of Senior Consultant at ConcordiaValsource, LLC. His over the years accomplishments include validation of all of the aspects of pharmaceutical and biotechnology production and quality management, technical support of multi-billion dollar drug product lines and the introduction of new products onto the market. He had 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 is leading PDA Water Interest Group. He holds a BS degree in Mechanical and Electrical Engineering Technology from Rochester Institute of Technology.