Pharmaceutical Technology Transfer Training Course

Practical Application of Technology Transfer (T19)

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

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 ISPE Good Practice Guide: Technology Transfer (Second 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).

  • October 03, 2018 - October 04, 2018
    New Brunswick, NJ United States

    Daily Schedule

    Daily Schedule at a Glance
    07.30 – 17.00 Registration Open
    08.30 – 17.00 Training Course
    10.00 – 10.30 Refreshment Break
    12.00 – 13.00 Lunch
    14.30 – 15.00 Refreshment Break

    Instructors

    Executive Director Quality

    Fees

    Type
    Early
    Before
    23 Jul
    Regular
    23 Jul -
    22 Aug
    Late
    After
    22 Aug
    Member US$
    1,735.00
    US$
    1,835.00
    US$
    1,935.00
    Nonmember US$
    2,130.00
    US$
    2,230.00
    US$
    2,330.00
    Government US$
    800.00
    US$
    800.00
    US$
    800.00

    Group Discounts

    • 3 - 5 participants - Save 10%
    • 6 - 10 participants - Save 15%
    • 11 or more participants - Save 20%

    To qualify, all registrant information must be submitted at the same time. Only ONE payment to cover all registrations will be accepted. 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.