Date

November 24, 2020

Duration

90 minutes

Time

11 AM EST/8 AM PST/9:30 PM IST

Level

Advanced Professional

This webinar discusses effective Pharmaceutical Technology Transfer procedures as they are currently practiced 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.

Why you should attend?
  • To initiate, manage, control and successfully complete effective, efficient and compliant technology transfer project
  • To learn about 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 in the virtual workshop:
  • 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
Key learning objectives:
  • 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
Who will benefit?

Professionals across Pharmaceutical, Biopharmaceutical, Nutraceuticals in the below 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

Instructor Bio

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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