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. Igor has published articles and white papers in pharmaceutical professional magazines and textbooks. In addition, he has been a presenter at Interphex. He is also very active with PDA, participating in several Task force groups and authoring PDA Technical Reports 29 (Points to Consider for Cleaning Validation) and 60 (Process Validation). He leads the PDA Water Interest Group. Igor holds a BS degree in Mechanical and Electrical Engineering Technology from Rochester Institute of Technology. In addition, Igor has conducted extensive auditing and lead training programs for pharmaceutical and biopharmaceutical practitioners abroad (China, India, Israel and other countries).
Recent blog posts from Igor
Cleaning Validation Stage 1: On a Quest for Process Understanding
Want to learn more about cleaning validation? The use of data collection, analysis, and evaluation are the most critical tasks in a cleaning validation program.
Cleaning Validation Stage 2: Performance Qualification
The second stage of the validation lifecycle is called Process Qualification. This stage is customary and is referred to as Cleaning Validation. Usually, three consecutive successful runs are performed to qualify the process using well characterized, well documented and consistent cleaning procedures.