Best Practices for Effective Pharma Technology Transfer: From R&D to Clinical to Commercial

Duration: 90 Minutes
This webinar discusses effective Pharmaceutical Technology Transfer procedures as they are currently practices by successful pharmaceutical and biopharmaceutical firms. It introduces 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 creation of a powerful, effective and efficient governance team. In addition we will outline 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.
Technology Transfer
Instructor: Igor Gorsky
Product ID: 502023
Objectives of the Presentation
  • 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
Why Should you Attend
  • 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 appropriate phase-based stage-gate approach
Areas Covered
  • Project management
  • Product, process and formulation development
  • Safety and Environment
  • Analytical development
  • Microbiological concerns
  • Technical services
  • Operations including Manufacturing and Packaging
  • Quality assurance and Quality control
  • Regulatory affairs
Who will Benefit
Departments that typically participate in Technology Transfers:
  • Project management
  • Product/process and formulation development
  • EH&S
  • Analytical development
  • Microbiology
  • Technical services
  • Operations
  • Manufacturing
  • Packaging Engineering
  • Serialization
  • Quality assurance
  • Quality control
  • Regulatory affairs
Topic Background
In today's pharmaceutical and biopharmaceutical industry effective and efficient technology transfer becomes an important task that needs to be approached in standardized and consistent manner. From a development through clinical studies to process performance qualification to launch of products, their processes are continuously transferred from one platform to the other. Additionally, contract facilities may be utilized by the owners of products and technology transfer is utilized for these purposes as well. This webinar will provide an overview of the standardized approach to technology transfer projects.
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Instructor Profile:
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 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.
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