BIO07030 2019 BioPharmaceutical Quality Systems
Full Title
BioPharmaceutical Quality Systems
Transcript Title
BioPharmaceutical Quality Syst
Code
BIO07030
Attendance
N/A %
Subject Area
BIO - Bio Tech/Eng/Chem
Department
LIFE - Life Sciences
Level
07 - NFQ Level 7
Credit
05 - 05 Credits
Duration
Semester
Fee
€
Start Term
2019 - Full Academic Year 2019-20
End Term
9999 - The End of Time
Author(s)
Paul Walsh
Programme Membership
SG_SBIOP_J07 201900 Bachelor of Science in Biopharmaceutical Science (Add-on)
SG_SBIOE_E07 201900 Certificate in Bioprocess Engineering
SG_SBIOM_H08 202000 Bachelor of Science (Honours) in Biomedical and BioIndustrial Sciences
SG_SAPMS_H08 202000 Bachelor of Science (Honours) in Applied Medical Sciences
Description
This module will demonstrate the importance of the systems approach both to quality and manufacturing
within the highly regulated biopharmaceutical sector.
Learning Outcomes
On completion of this module the learner will/should be able to;
1.
Evaluate the development and importance of Quality System Standards.
2.
Identify the principal requirements of a Quality System.
3.
Evaluate the benefits of the ISO 9000:2005 and ISO17025:2005 Quality Systems
4.
Illustrate the importance of documentation as required by a Quality System.
5.
Discuss the importance of Good Manufacturing Practice in a regulated environment
6.
Describe the main contents of a Quality Manual.
Teaching and Learning Strategies
N/A
Module Assessment Strategies
The assessment approach for this module will be 60% Continuous Assessment with a range of assessment methods employed including some of the following: short-form assessment exams incl. MCQ
Repeat Assessments
60% Continuous Assessment will include a range of assessment methods including some of the following: short-form assessment exams incl. MCQ
Indicative Syllabus
The development of the concept of quality and quality systems.
Assessment of the cost of quality, prevention costs, appraisal costs, failure costs.
Quality Management Systems : implementations and benefits, Regulatory bodies, Eudralex, ICH guidance docs
Quality System requirements ISO9000 :2005/ ISO 9001:2008, ICH Q 09 and Q10
Documentation and Documentation Change Control quality records.
Auditing, types of audit, non conformances and corrective action, the importance of self inspection.
Good Manufacturing Practice (GMP) / Good Laboratory Practice (GLP)/ ISO 17025
Principals of Validation, system, product, equipment etc.
Coursework & Assessment Breakdown
Coursework & Continuous Assessment
50 %
End of Semester / Year Formal Exam
50 %
Coursework Assessment
| Title | Type | Form | Percent | Week | Learning Outcomes Assessed | |
|---|---|---|---|---|---|---|
| 1 | CA | Coursework Assessment | Assessment | 30 % | Week 4 | 1,2,3,4,5,6 |
| 2 | Multiple Choice Questions | Coursework Assessment | Multiple Choice/Short Answer Test | 20 % | Week 10 | 1,2,3,4,5,6 |
End of Semester / Year Assessment
| Title | Type | Form | Percent | Week | Learning Outcomes Assessed | |
|---|---|---|---|---|---|---|
| 1 | Final exam | Final Exam | Closed Book Exam | 50 % | End of Semester | 1,2,3,4,5,6 |
Online Learning Mode Workload
| Type | Location | Description | Hours | Frequency | Avg Workload |
|---|---|---|---|---|---|
| Lecture | Online | Online delivery | 2 | Weekly | 2.00 |
| Tutorial | Online | tutorial | 1 | Weekly | 1.00 |
Total Online Learning Average Weekly Learner Contact Time 3.00 Hours
Module Resources
Non ISBN Literary Resources
N/A
Journal Resources
N/A
URL Resources
ISO guidelines, ICH guidelines
Other Resources
N/A
Additional Information
N/A