Igor Gorsky
Principal Process Validation Consultant
Igor Gorsky has been a pharmaceutical, biopharmaceutical and medical device industry professional for over 43 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 where he oversaw global validation efforts, including Analytical Methodology, Equipment and Facilities Qualification, Process, Packaging, Shipping, Computer and Cleaning Validation and Environmental Monitoring Programs. He is currently holding the position of Senior Consultant at Valsource, LLC. His over the years accomplishments include validation of all of the aspects of pharmaceutical, biotechnology and medical device production and quality management, technical support of multi-billion-dollar drug product lines and introduction of new products onto the market. He developed Analytical Technology Policies, Procedures and Master Plans for numerous biopharmaceutical firms based on the latest global regulations. He also developed Analytical Technology qualification programs for a number of pharmaceutical and biopharmaceutical firms. He published numerous articles and white papers in pharmaceutical professional magazines. He is the author of two books on Pharmaceutical Scale Up and Process Validation. In addition, he has been a presenter at PDA Annual Meetings, Interphex, UBM International Workshops and other forums. He is also very active with PDA and ASTM participating in several Task force groups authoring PDA Technical Reports 29 (Points to Consider for Cleaning Validation), 60 (Process Validation), 60-2 (Process Validation Annex 1: OSD and SSD Dosage). He is leading PDA Water Interest Group. He also is a member of ASTM E55, authoring ASTM E3106-18 Science and Risk Approach to Cleaning Validation, as well as several other standards (ASTM E3219, E3263, G121, G122). He holds a BS degree in Mechanical/Electrical Engineering Technology from Rochester Institute of Technology.
