Short Title:Technology Transfer for Bio and Pharmaceutical Processes
Full Title:Technology Transfer for Bio and Pharmaceutical Processes
Language of Instruction:English
Module Code:TNTR H6002
 
Credits: 10
Field of Study:Science
Module Delivered in 1 programme(s)
Reviewed By:JOHN BEHAN
Module Author:ED CAREY
Module Description:The module will provide best practice for pharmaceutical process design and technology transfer
Learning Outcomes
On successful completion of this module the learner will be able to:
LO1 Identify and integrate the key activities in a technology transfer project
LO2 Interpret best practice using both professional and regulatory guides for technology transfer activities
LO3 Apply best practice to achieve regulatory compliance for API, Biotech and Finished Dose Processing
 

Module Content & Assessment

Course Work
Assessment Type Assessment Description Outcome addressed % of total Assessment Date
Written Report Pharmaceutical Validation project 1 20.00 n/a
End of Module Formal Examination
Assessment Type Assessment Description Outcome addressed % of total Assessment Date
Formal Exam End-of-Semester Final Examination 1,2,3 80.00 End-of-Semester

TU Dublin – Tallaght Campus reserves the right to alter the nature and timings of assessment

 

Module Workload

Workload: Full Time
Workload Type Workload Description Hours Frequency Average Weekly Learner Workload
Lecture API, Biotechnology and Finished dose processing and technology transfer activities 3.00 Every Week 3.00
Independent Learning Research and background reading 9.00 Every Week 9.00
Total Weekly Learner Workload 12.00
Total Weekly Contact Hours 3.00
Workload: Part Time
Workload Type Workload Description Hours Frequency Average Weekly Learner Workload
Lecture API, Biotechnology and Finished Dose processing and technology transfer activities 3.00 Every Week 3.00
Independent Learning Research and background reading 9.00 Every Week 9.00
Total Weekly Learner Workload 12.00
Total Weekly Contact Hours 3.00
 

Module Resources

Recommended Book Resources
  • Udo Kragl; with contributions by A. Aivasidis... [et al.] 2005, Technology transfer in biotechnology, Springer [ISBN: 978-3540224129]
  • Laura Brown and Tony Grundy 2011, Project Management for the Pharmaceutical Industry, Gower [ISBN: 978-1409418948]
  • ISPE Good Practice Guide 2003, Technology Transfer, ISPE
  • ISPE Baseline Guide 2004, Biopharmaceuticals, ISPE
  • ISPE Baseline Guide 2009, Oral Dosage Forms, ISPE
  • ISPE Baseline Guide 2007, Active Pharmaceutical Ingredients
This module does not have any article/paper resources
This module does not have any other resources
 

Module Delivered in

Programme Code Programme Semester Delivery
TA_SPHAR_M_X Masters in Pharmaceutical Manufacturing & Process Technology 2 Mandatory