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.This training course on Pharmaceutical Technology Transfer identifies criteria for successful technology transfer and provides ‘how to’ examples which can be individually tailored, depending on the type and scope of transfer.

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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

  • online-live
    Online Live
    4 - 5 Aug 2021

    Daily Schedule at a Glance

    Training course times are listed in Eastern Standard Time (EST). Find your personal viewing time on the World Clock.

    0830 – 0845 Login
    0845 - 0900 Introductions
    0900 - 1030 Course Content & Exercise
    1030 - 1045 Break
    1045 - 1215 Course Content & Exercise
    1215 - 1300 Lunch
    1300 - 1430 Course Content & Exercise
    1430 - 1445 Break
    1445 - 1615 Course Content & Exercise
    1615 - 1630 Wrap-up, Questions, Discussion 
    0830 – 0845 Login
    0845 - 0900 Recap
    0900 - 1030 Course Content & Exercise
    1030 - 1045 Break
    1045 - 1215 Course Content & Exercise
    1215 - 1300 Lunch
    1300 - 1430 Course Content & Exercise
    1430 - 1445 Break
    1445 - 1615 Course Content & Exercise
    1615 - 1630 Wrap-up, Questions, Discussion 

    Featured Instructors

    Registration Fee

    REGULAR
    Member US$ 1,785.00
    Nonmember   US$ 2,085.00
    Government / Academia / Emerging Economies US$ 550.00
    Student US$ 90.00

    Now Your Whole Team Can Participate in an ISPE Learning Experience

    • 3 - 5 participants - Save 10%
    • 6 - or more participants - Save 20%

    Group discount applies to Member/Nonmember rate only. To qualify, all registrant information must be submitted at the same time. Registrations that arrive later will NOT be eligible for the group discount. Cannot be combined with other offers. To register as a group, please contact ISPE by telephone, +1-813-960-2105 or by email, ask@ispe.org.