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Best Practices for Effective Pharma Technology Transfer
From R&D to Clinical to Commercial
LIVE TRAINING
9th - 10th December 2025
Who is Your Trainer
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 Director of Global Pharmaceutical Technology at Shire Pharmaceuticals. He is currently holding a position of Principal Consultant at ValSource Inc. 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 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.
Course Overview
This course discusses effective Pharmaceutical Technology Transfer procedures as they are currently practiced by successful pharmaceutical and biopharmaceutical firms. It introduces a compliant modular approach to technology transfer projects that covers multiple disciplines including Project Management, Analytical and Microbial Quality Control, Operations, Quality Assurance Safety, Engineering, Regulatory Affairs and other relevant areas.
It provides guidance for the creation of a powerful, effective and efficient governance team. In addition, we will outline a step-by-step joint quality review stage-gate approach that will help dissecting complex technology transfer exercises into manageable and compliant phases taking into consideration regulatory filing recommendations.
We will also include discussion on Risk and Knowledge Management tools as they apply to Technology Transfer projects.
Key Learning Objectives
- To initiate, manage, control and successfully complete effective, efficient and compliant technology transfer project.
- To learn risk-based modular approach to technology transfer
- To learn how to conduct joint development and technology transfer reviews, outlining an appropriate phase-based stage-gate approach
- Effective project management of technology transfers
- Appropriate governance of technology transfer projects
- Modular approach introduction
- Using risk management and knowledge management
- Understanding of Joint Development and Technology Transfer Reviews
- Regulatory filing and Pre-approval inspection preparedness