Short Title:Application of QRM Principles in Pharmaceutical and Medical Device Operations
Full Title:Application of QRM Principles in Pharmaceutical and Medical Device Operations
Language of Instruction:English
Module Code:QRMP H1001
 
Credits: 5
Field of Study:Biology and biochemistry
Module Delivered in 1 programme(s)
Reviewed By:JOHN BEHAN
Module Author:ED CAREY
Module Description:This module will allows students to gains the knowledge and skills to execute QRM projects within the Life Science Sector.
Learning Outcomes
On successful completion of this module the learner will be able to:
LO1 Discuss the Regulatory guidelines impacting the pharmaceutical and medical device sectors.
LO2 Critically analyse and evaluate the optimal approaches to interpreting and implementing the associated regulatory guidelines.
LO3 Evaluate implementation strategies for risk identification and assessment activities through utilisation of various QRM tools as outlined in ICH guidelines.
LO4 Critically analyse the utilisation of QRM principles in alternative sectors and how these principles may successfully transfer to pharmaceutical and medical device sectors.
 

Module Content & Assessment

Course Work
Assessment Type Assessment Description Outcome addressed % of total Assessment Date
Assignment 1.Draw a process map of the manufacturing process. 2.Chose two manufacturing steps and identify the potential failure modes and potential effects for each failure mode selecting the relevant tools from the lecture slides. 3. Perform a risk assessment on these two process steps using the tools outlined in the lecture slides (e.g. FMEA/HACCP). 4.Discuss the benefits and limitations of this analytical process. 5. Discuss the risk involved in the process above. 1,2,3,4 100.00 Ongoing
No End of Module Formal Examination

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 No Description 3.00 Every Week 3.00
Independent Learning No Description 5.00 Every Week 5.00
Total Weekly Learner Workload 8.00
Total Weekly Contact Hours 3.00
Workload: Part Time
Workload Type Workload Description Hours Frequency Average Weekly Learner Workload
Lecture No Description 3.00 Every Week 3.00
Independent Learning No Description 5.00 Every Week 5.00
Total Weekly Learner Workload 8.00
Total Weekly Contact Hours 3.00
 

Module Resources

Recommended Book Resources
  • Jose Rodriguez-Perez 2012, Quality Risk Management in the FDA-Regulated Industry
  • Mollah, Long and Baseman. 2013, Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing, Wiley., Wiley
This module does not have any article/paper resources
Other Resources
  • Regulatory agencies: FDA/ICH 2016, ICH Q9 Q10
 

Module Delivered in

Programme Code Programme Semester Delivery
TA_SSPPM_B Certificate in Pharmaceutical and Medical Device Manufacturing (Special Purpose Award)v2 1 Mandatory