2013 Barcelona Training, September 2014

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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 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).

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DatesLocationsInstructors 
30 Mar 2017 -
31 Mar 2017
Tampa, FL USA Dr. Louis W. Yu, PhD
Register

Fees and Daily Schedule

TypeOn or Before
28 February
After
28 February
Member US$1,735 US$1,935
Nonmember US$2,125 US$2,325
Government US$955 US$1,065
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
DatesLocationsInstructors 
04 Oct 2017 -
05 Oct 2017
Tampa, FL USA Dr. Louis W. Yu, PhD
Register

Fees and Daily Schedule

TypeOn or Before
04 September
After
04 September
Member US$1,735 US$1,935
Nonmember US$2,125 US$2,325
Government US$955 US$1,065
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

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.

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