Pharmaceutical Technology Transfer Training Course

Level: Intermediate
ISPE CEUs: 1.3
Type: Classroom Training Course

Practical Application of Technology Transfer (T19)


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.

Technology Transfer Cover Image

Immediately apply the course learning objectives using the electronic download of the Good Practice Guide: Technology Transfer 3rd Edition you'll receive by attending this course.

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

Take Back to Your Job

Understand technology transfer planning and success criteria including  

  • Forming the transfer team and developing the charter    
  • Consolidating knowledge for transfer and developing a technology transfer proposal 
  • Identifying risks, conducting a risk assessments and developing technology transfer plan
  • Executing the transfer
  • Developing the process (procedure) qualification
  • Finalizing the transfer and performing the review

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.

Community of Practice (COP)

This training course is of particular interest to existing and future members of the ISPE Product and Process Development Communities of Practice (COPs).

  • 14 May 2020 - 15 May 2020
    North Bethesda, MD United States

    Daily Schedule

    Daily Schedule at a Glance
    07:00 – 08:30 Registration Open
    08:30 – 17:00 Training Course
    10:30 – 11:00 Refreshment Break
    12:00 – 13:00 Lunch
    15:00 – 15:30 Refreshment Break
    Placeholder Person Graphic
    Executive Director CMC Regulatory Affairs

    BY 14 Apr

    Member US$
    Non-member   US$
    Government / Academia US$
    Student Member US$

    AFTER 14 Apr

    Member US$
    Non-member   US$
    Government / Academia US$
    Student Member US$

    Mail or Fax Registration

    Not paying by credit card? Use the registration form to pay by mail or by fax.

    Group Discounts

    • 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,