In partnership with NUS

Academy of GxP Excellence since 2009

Objective

 

To benefit project managers and technical professionals in understanding the advantage of technology transfers, the adverse consequences that may be associated with improper planning and the approach to successful technology transfers.

 

Description

 

There are an increasing number of technology transfers in pharmaceutical industry today due to its impending benefits such as creating a competitive edge against its competitors. However, improper planning and implementation of such activity can lead to unnecessary monetary loss, compliance issues and disruption in operation for both companies. This course will explore the types of technology transfers among companies and the issues affecting the transfer within and among companies, including the regulatory requirements that are associated with it. In order to cope with such movements, strategies justified with examples, will be explored.

 

Course Outline

 

  • Product and technology transfers - intellectual property, technology transfer, skills transfer, regulatory considerations

  • Benefits of technology transfer

  • Variation procedures - types of variations, advantages and disadvantages

  • Challenges

    • Technical Challenges - Manufacturing process, validation, stability studies, risk Management and technology transfer

    • Logistical challenges

    • Suppliers, raw materials, shipment

    • Human challenges - team membership and team roles, cross-cultural issues

  • Approach to successful technology transfers

    • Process understanding and information

      • Quality-by-Design (QbD)

      • Critical Process Parameters (CPP)

    • Product understanding and information

    • Project management,  planning and scheduling

      • Identify the technology transfer critical path etc

 

Learning Outcome

 

Upon completion of this course the attendees will be able to:

  1. Appreciate where Technology Transfer will fit into the life cycle of a pharmaceutical product

  2. Understand the regulatory requirements for technology transfers

  3. Understand the importance of planning technology transfer and the requirements for successful technology transfers

  4. Gain an understanding of the challenges faced in technology transfer

 

 

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