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 an 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.
September 19 2019
02 : 30 PM EST
Best Practices for Implementing an Effective Cleaning Validation (using principles of upcoming ASTM E3106)
This webinar discusses the implementation of Cleaning Validation programs based on global Cleaning Validation Guidelines as they are currently available for pharmaceutical and biopharmaceutical industries. What makes this webinar special and unique is a very rare glimpse into upcoming ASTM E3106 for Cleaning Validation. This is a Risk-Based Science-Based Lifecycle approach guidance document that was fully v..
August 22 2019
02 : 30 PM EST
This webinar discusses global Cleaning Validation Guidelines as they are currently available for pharmaceutical and biopharmaceutical industries. In addition, it describes the use of QRM (quality risk management) in Cleaning Validation and the growing trend of applying this approach to life-cycle of the product manufacturing process. Establishing of health-based Cleaning Validation limits also discussed in ..