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The Art Of Technology Transfer In Drug Development: Developing And Building A Framework Of Success

This course builds practical capability to structure repeatable technology transfer activities across pharmaceutical development using risk assessment, knowledge management, and process understanding. Participants will strengthen internal decision-making by connecting QTPP, CQAs, control strategy, and transfer planning into a coordinated operational approach. This Course is designed for professionals involved in pharmaceutical development, process transfer, quality systems, and technical operations oversight.

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US $190 per learner

30-Days Unlimited Streaming Access

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To Get 30-Day Access to ONLY this Course 

US $190 per learner
  • This course is Included in Subscription Pack
Subscription include access to entire Learning Library
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  • Instructor : Scott R. Thatcher
  • Study time : 90 Minutes
  • Skill Level: Intermediate
  • Course ID: TF2177
  • Assessment & Certification Included
  • Ask the Expert

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About the Course

Technology transfer remains one of the most critical and inconsistently executed activities in pharmaceutical and biopharmaceutical development. In global development environments, organizations depend on repeatable transfer practices to maintain continuity between development, manufacturing, quality, and regulatory expectations. Because formal regulatory direction on technology transfer remains limited, companies must establish internal processes capable of preserving product and process knowledge throughout development activities.


This course addresses the operational and scientific elements required to support successful transfer execution across drug development programs. The material connects pharmaceutical development activities with QTPP, Critical Quality Attributes, risk assessment, control strategy, Quality by Design, materials, methods, and process considerations. Additional focus is placed on knowledge management practices, data systems, pre-transfer gap analysis, protocol development, reporting structure, and project planning. The session also examines critical success factors that influence long-term consistency and transfer reliability across organizations.

  • Strengthen Technology Transfer Decision-Making:

    Participants will gain a structured approach for connecting development knowledge with transfer execution activities across pharmaceutical programs. The course clarifies how QTPP, CQAs, risk assessment, and control strategy contribute to transfer readiness, helping teams reduce operational gaps, improve internal coordination, and support consistency when transferring products, processes, methods, and associated documentation.

  • Build a Repeatable Internal Transfer Process:

    Organizations operating across global development environments often face variability in transfer execution due to limited regulatory direction. This course provides practical perspective on creating transfer frameworks supported by project plans, protocols, reporting practices, knowledge management, and data systems. Participants will better recognize critical concepts that influence transfer continuity, process understanding, and long-term operational reliability.

Key Areas Covered

  • Technology transfer perspective, definitions, and critical success factors across pharmaceutical development activities
  • QTPP, Critical Quality Attributes (CQAs), and Quality by Design (QbD) considerations supporting transfer readiness
  • Risk assessment approaches and pre-transfer gap analysis for process and knowledge evaluation
  • Materials, components, manufacturing processes, analytical methods, and associated development considerations
  • Knowledge management practices, critical concepts, and data systems supporting transfer continuity
  • Technology transfer framework development including project plans, protocols, reports, references, and process execution

Who Must Attend

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

Quality training, expert insights, and answers that matter. Know your Expert

SCOTT R. THATCHER

Scott Thatcher is a 20+ year veteran of the pharma and biopharma industry with experience supporting CMC development and commercial launch activities across multiple drug programs and delivery systems. His background includes analytical chemistry, photostability studies, stress testing, and analytical method development and validation. He has contributed to regulatory submissions aligned with ICH Q1B expectations and has worked extensively with scientific data and development information critical to

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Good balance. Not too basic, not too deep. Worked well for mixed team.”


Manager, Regulatory Affairs

“Presenter handled questions well. Didn’t avoid anything.”



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“Would consider similar sessions again. Format worked for us.”



Director, Regulatory Affairs

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