2013 Atlanta Training, June 2014

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Practical Application of Technology Transfer (T19)

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

Date Location Country Instructor(s)
This course is not currently scheduled, but may be offered at your company site. Please contact ISPE for more information.

Description

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 course identifies criteria for successful TT 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.

Technology Transfer Cover Image

Immediately apply the course learning objectives using the complimentary copy of the ISPE Good Practice Guide: Technology Transfer (Second Edition).

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

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.

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).

Continuing Education Units  

ISPE will provide continuing education units (ISPE CEUs) for all North American and European courses. CEUs are nationally recognized units of achievement designed for those individuals continuing their education in their chosen field or profession. Verification of CEUs is based on attendance as well as satisfactory completion of all evaluation materials. Statements of credit will be available for download in your ISPE account within four weeks of the completion of training. Instruction for download will be sent when the CEUs are available. One hour of education programming equals 0.1 ISPE CEU credits.

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