Short Title:Pharmaceutical Management & Quality Systems
Full Title:Pharmaceutical Management & Quality Systems
Language of Instruction:English
Module Code:PHAR H6004
 
Credits: 10
Field of Study:Science
Module Delivered in 1 programme(s)
Reviewed By:JOHN BEHAN
Module Author:ED CAREY
Module Description:The purpose of this module is to provide an organisational structure for both management and quality systems together with implementation strategies essential for pharmaceutical manufacturing companies to remain competitive and compliant.
Learning Outcomes
On successful completion of this module the learner will be able to:
LO1 Design a program for Lean Manufacturing
LO2 Interpret ICH,FDA and EMEA guides to achieve GMP compliance.
LO3 Design a project plan for Technology Transfer
 

Module Content & Assessment

Course Work
Assessment Type Assessment Description Outcome addressed % of total Assessment Date
Project Submit Green Belt Project based on 24 hours activity.   30.00 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 70.00 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 Classroom or online 3.00 Every Week 3.00
Independent Learning Reading literature/relevant textbooks 3.00 Every Week 3.00
Lecturer/Lab Supervised project activity 24.00 Once per Semester 1.60
Total Weekly Learner Workload 7.60
Total Weekly Contact Hours 4.60
Workload: Part Time
Workload Type Workload Description Hours Frequency Average Weekly Learner Workload
Lecture Classroom or online 3.00 Every Week 3.00
Independent Learning Time Reading literature/relevant textbooks 3.00 Every Week 3.00
Lecturer/Lab Supervised project activity 24.00 Once per Semester 1.60
Total Weekly Learner Workload 7.60
Total Weekly Contact Hours 4.60
 

Module Resources

Recommended Book Resources
  • Jeffrey K. Liker 2004, The Toyota Way, McGraw-Hill New York [ISBN: 978-0071392310]
  • Mollah, Hamid / Baseman, Harold / Long, Mike 2011, Application of Risk Management for Pharmaceutical and Biological Products Manufacturing, Wiley [ISBN: 978-0-470-55234-6]
  • James L. Vesper, 2006, Risk Assessment and Risk Management in the Pharmaceutical Industry, GMP Publishing [ISBN: 1-930114-90-7]
  • Jackelyn RODRIGUEZ 2011, CAPA in the Pharmaceutical and Biotech Industries, Biohealthcare Publishing [ISBN: 978-1907568589]
  • Brian K. Nunnally/John S. McConnell 2007, Six Sigma in the Pharmaceutical Industry: Understanding, Reducing, and Controlling Variation in Pharmaceuticals and Biologics, CRC Press [ISBN: ISBN-13: 978-1420054392]
Required 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