ARTICLES BY IGOR GORSKY
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![Old manuscript book]( "A Brief History Of Parenteral Process Validation — How We Got Here")
A Brief History Of Parenteral Process Validation — How We Got Here6/29/2020Process validation has been at the center of attention of regulators and parenteral industry practitioners for years — more than 40 years to be exact. This article will look at how process validation evolved to become the primary means of ensuring consistent, high-quality production of parenterals.
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![Knowledge-Management-iStock-1166587507]( "Knowledge Management — Opportunities & Challenges For Legacy Drug Products")
Knowledge Management — Opportunities & Challenges For Legacy Drug Products6/1/2020This article will explore specific challenges of managing knowledge in a legacy manufacturing environment and propose viable, practical solutions that have been found to be effective. These solutions allow practitioners to increase product and process understanding as well as performance.
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![iStock-1031889634]( "Identifying Difficult-To-Clean Surfaces In Manufacturing And Packaging Equipment")
Identifying Difficult-To-Clean Surfaces In Manufacturing And Packaging Equipment4/15/2020This article describes a practical risk-based approach for assessing and identifying the surfaces, areas, or sites of manufacturing and packaging equipment that are cleaned upon completion of oral solid dosage manufacturing production.
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 as associate director of global pharmaceutical technology at Shire. He is currently principal consultant at ValSource. He is leading the PDA Water Interest Group and a PDA Task Force for revision of PDA TR 29: Points to Consider for Cleaning Validation. In addition, he is a member of ASTM E55 and one of the authors of ASTM E3106 and E3207. He has a BS in mechanical/electrical engineering technology from Rochester Institute of Technology.