BIO08049 2016 Quality Systems & Regulatory Affairs

General Details

Full Title
Quality Systems & Regulatory Affairs
Transcript Title
Quality Systems
Code
BIO08049
Attendance
N/A %
Subject Area
BIO - Bio Tech/Eng/Chem
Department
LIFE - Life Sciences
Level
08 - NFQ Level 8
Credit
10 - 10 Credits
Duration
Semester
Fee
Start Term
2016 - Full Academic Year 2016-17
End Term
2020 - Full Academic Year 2020-21
Author(s)
James Brennan, Stephen Daly, Paul Walsh
Description

This module addresses ICH legislation for biopharmaceutical processing. It also introduces GMP,

environmental and health and safety legislation relevant to the biopharmaceutical industry.

 

Learning Outcomes

On completion of this module the learner will/should be able to;

1.

Demonstrate abroad-based knowledge and understanding of the main US and EU institutions, legal instruments, ICH process and workings of EMEA.

2.

Evaluate applicability of current environmental, health and safety legislation for biopharmaceutical industry.

3.

Source and evaluate procedures and directives currently regulating good manufacturing practices (GMP).

4.

Integrate knowledge and understanding of CTD, variations procedures and Clinical Trial Legislation to evaluate relevant case studies.

5.

Perform research on a relevant topic and analyse, evaluate and draw conclusions accordingly.

6.

Communicate and explain scientific data relating to quality systems and regulatory affairs.

7.

Evaluate the development and importance of Quality System Standards and how they link to legislation

8.

Identify the principal requirements of a Quality System and integration of Good Manufacturing Practice in a regulated environment.

Teaching and Learning Strategies

As above.

 

Module Assessment Strategies

Continuous Assessment of Course Work - 30% of marks.

End of term online exam - 30% of marks.

Mini research project/practical auditing evaluation - 40% of marks.

The miniproject is a MANDATORY form of assessment for any modules on this programme with a miniproject component.

 

 

Repeat Assessments

Set by the lecturer depending on the failed element.

Indicative Syllabus

History of Regulatory Affairs, Definitions, Regulatory framework, GMP.

US FDA, Introduction to European legislation & terminology, Licenses required.

European Registration Process. EMEA. Responsibilities of MAH, Manufacturer/QP.

Principal Reg Affairs authorities UK/Ireland.

Irish Pharmaceutical Legislation.

Summary of Product Characteristics and Variations.

Environmental Legislation. Health and Safety Legislation.

CTD & Clinical Trial Legislatio

ISO 9000:2005 and ISO17025:2005 Quality Systems

 

Coursework & Assessment Breakdown

Coursework & Continuous Assessment
70 %
End of Semester / Year Formal Exam
30 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Open Book Exam Online Continuous Assessment Open Book Exam 15 % Week 4 1,2,4,7,8
2 Open Book Exam Online Continuous Assessment Open Book Exam 15 % Week 9 1,2,4,7,8
3 Individual Project Mini Research/auditing assessment Continuous Assessment Individual Project 40 % Week 15 5,6,7,8

End of Semester / Year Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Other Exam Online Final Exam Closed Book Exam 30 % Week 13 1,2,3,4,7,8
             
             

Full Time Mode Workload


Type Location Description Hours Frequency Avg Workload
Individual Diary / Log Book Not Specified Independent Learning 4 Weekly 4.00
Total Full Time Average Weekly Learner Contact Time 4.00 Hours

Part Time Mode Workload


Type Location Description Hours Frequency Avg Workload
Problem Based Learning Science Laboratory Audit Workshop 8 Once Per Module 0.53
Total Part Time Average Weekly Learner Contact Time 0.53 Hours

Distance Learning Mode Workload


Type Location Description Hours Frequency Avg Workload
Lecture Distance Learning Suite Online lectures 2 Weekly 2.00
Directed Learning Distance Learning Suite Directed Learning 6 Weekly 6.00
Total Distance Learning Average Weekly Learner Contact Time 8.00 Hours

Module Resources

Non ISBN Literary Resources

Medicines and Healthcare Products Regulatory Agency (MHRA), Rules and Guidance for

Pharmaceutical manufacturers & distributors 2007 (Orange Guide). Pharmaceutical Press

ISBN:9780853697190.

"Development and Control of Medicines and Medical Devices"; RJ Harman, Pharmaceutical Press.

Pharmaceutics: The Science of Dosage Form Design; M.E Aulton

URL Resources

N/A

Other Resources

N/A

Additional Information

N/A