Faculty: Scott R. Thatcher ‎ ‎ ‎ ‎ ‎‎ ‎ ‎ |‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ ‎ Code: FDB2177


  • Date: 3/25/2024 11:00 AM - 3/25/2024 12:30 PM
  • Time zone: Eastern Time (US/Canada) Online Event

 

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.

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

Who Should Attend:

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

Course Director: SCOTT R. THATCHER

Scott Thatcher is a 20+ year veteran of the pharma/biopharma industry. He is a published author in analytical chemistry and photostability studies.  He has contributed to the CMC development and launch of multiple drug programs in different delivery systems. He has executed stress studies for the development and validation of 100s of analytical methods. He is an expert in the interpretation of the ICH Q1B guideline and has contributed to multiple regulatory submissions that met regulatory requirements and subsequent agency approval.