Pharmaceutical Technology Transfer Training Course

Practical Application of Technology Transfer (T19)

Overview

Developing effective protocols for technology transfer is essential for addressing current industry challenges and evolving business needs. As the industry continues to experience changes, technology transfer for active pharmaceutical ingredients (APIs), finished dosage forms and analytical methods between development and manufacturing sites and contract manufacturing organizations (CMOs) has become increasingly important. and real-world examples as tools for industry and regulators to use when conducting and evaluating technology transfer activities. This training course will show you how to develop and execute an effective technology transfer plan.

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What You Will Learn

  • Assemble a transfer team
  • Develop a charter
  • Develop a technology transfer proposal and plan
  • Execute a transfer
  • Develop the process (procedure) qualification
  • Finalize a transfer
  • Conduct a review

Resources and Activities

ISPE good practice guide heating ventilation

Course Modules

  • Introduction to Technology Transfer
  • Knowledge: What is it?
  • Planning & Success Criteria
  • Quality Risk Management
  • Phases of the Transfer Process, including Validation
  • Analytical Procedures Transfer
  • Drug Substance Transfer
  • Drug Product Transfer

Who Should Attend

  • This course is intended to be useful to anyone involved in technology transfer whether in relation to commercial transfer between manufacturing sites or transfer to manufacturing from development or within development.
  • Professionals with technology transfer responsibilities, including regulatory compliance associates, process development scientists, facilities engineers, validation and quality assurance specialists, manufacturing managers, and regulators.

Additional Course Details

Technology transfer (TT) includes knowledge transfer, science and risk-based principles including ICH Q8, Q9, Q10, Q11 and efficient processes to meet evolving business needs. As the industry continues to experience changes, technology transfer for active pharmaceutical ingredients (APIs), finished dosage forms and analytical methods between development and manufacturing sites and contract manufacturing organizations (CMOs) has become increasingly important. This classroom course identifies criteria for successful technology transfer and provides ‘how to’ examples which can be individually tailored, depending on the type and scope of transfer. It takes into account current industry challenges and real-world examples as tools for industry and regulators to use when conducting and evaluating technology transfer activities.

Develop an effective process for Technology Transfer including the exchange of knowledge between the sending unit and the receiving unit for drug substance, drug product and analytical procedures.

Communities of Practice

This training course is of particular interest to existing and future members of the ISPE Process/Product Development Community of Practice.


Daily Schedule and Pricing

This course is not currently scheduled, but may be offered at your company site. Please contact ISPE for more information