🎤  Scott R. Thatcher‎       |  📅  Recording Available   |  🕒  90 Minutes


AREAS COVERED IN THE SESSION:  

  • Perspective
  • Success Factors
  • Pharmaceutical Development
    • QTPP
    • Critical Quality Attributes (CQAs)
    • Risk Assessment
    • Control Strategy
    • Quality by Design (QbD)
    • Materials and Components
    • Process
    • Methods
  • Knowledge Management
    • Critical Concepts
    • Data Systems
  • Technology Transfer Process
    • Definitions
    • Keys to Successful Technology Transfer
    • Technology Transfer Framework
    • Pre-transfer Gap Analysis and Risk Assessment
    • Project Plan
    • Protocols(s)
    • Report(s)
  • Wrap Up
  • References
  • Questions



Description

This course will cover will cover key learning approach to the Art of Technology Transfer.  We will take a look at an overall perspective on Technology Transfer from Industry. Talk about key learned success factors.  Discuss an approach to Pharmaceutical Development that captures critical information to technology transfer along the way. We will discuss the important aspects of the Knowledge Management process and impact on Technology Transfer.  And finally, we will discuss the overall approach to building a Technology Transfer framework that will deliver a successful and repeatable process.

Why You Should Attend:

In conducting drug development in a global environment, it is vital to the health of the organization to conduct Technology Transfer successfully and repeatedly. Current regulatory guidance on Technology Transfer is minimal.  It is up to Leadership and Scientists to learn this Art and build an internal Technology Transfer framework that is integrated into the drug development process for sustainable success.

Who Should Attend:

  • Leadership/Managers
  • Analytical Scientists
  • Formulations Scientists
  • Regulatory Scientists
  • Quality Assurance Departments
  • Document Control Specialists
  • Information Technology Departments
  • Engineering Departments

 

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