| Title: | Introduction to Validation |
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| Long Title: | Introduction to Validation |
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| Field of Study: |
Manufacturing Engineering
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| Valid From: |
Semester 1 - 2018/19 ( September 2018 ) |
| Next Review Date: |
May 2023 |
| Module Coordinator: |
NIALL MORRIS |
| Module Author: |
ANN TOEBES |
| Module Description: |
This module will provide students with an introductory knowledge of validation as applied in industry. It aims to deliver a broad scope of industry relevant validation topics that will give students valuable insight and raise their awareness of the importance, implementation and impact of validation in industry. |
| Learning Outcomes |
| On successful completion of this module the learner will be able to: |
| LO1 |
Describe validation and Quality Management |
| LO2 |
Explain GDP and GMP in an industry context |
| LO3 |
Apply industry validation practice across several sectors |
| LO4 |
Identify key principles of validation in Quality Control/Assurance |
| LO5 |
Explain international standards and regulations requirements and how they are applied in a GMP environment. |
| LO6 |
Identify documentation required for validation including process audits |
| LO7 |
Describe the processes used to manage non-conformances and improvement opportunities in a GMP environment. |
| Pre-requisite learning |
Module Recommendations
This is prior learning (or a practical skill) that is strongly recommended before enrolment in this module. You may enrol in this module if you have not acquired the recommended learning but you will have considerable difficulty in passing (i.e. achieving the learning outcomes of) the module. While the prior learning is expressed as named MTU module(s) it also allows for learning (in another module or modules) which is equivalent to the learning specified in the named module(s).
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Incompatible Modules
These are modules which have learning outcomes that are too similar to the learning outcomes of this module. You may not earn additional credit for the same learning and therefore you may not enrol in this module if you have successfully completed any modules in the incompatible list. |
| No incompatible modules listed |
Co-requisite Modules
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| No Co-requisite modules listed |
Requirements
This is prior learning (or a practical skill) that is mandatory before enrolment in this module is allowed. You may not enrol on this module if you have not acquired the learning specified in this section.
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| No requirements listed |
Module Content & Assessment
| Indicative Content |
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Quality Management
Define quality, quality and competitiveness. Quality costs as a driving force. Define quality assurance. Differentiate between Quality Control and Quality Assurance. Quality Culture and ethics. Regulatory bodies including the FDA, EMA, HPRA, EPA and HSA and their functions. Introduction to the Code of Federal Regulations, Eudralex and relevant international standards. The principles of GMP. The role of the employee in delivering quality products.
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Quality Assurance Aspects
The importance of documentation, types of documents such as standard operating procedures, specifications, batch manufacturing records, deviation reports, validation poliecies, protocols and reports etc. Writing and controlling official procedures. Edition, numbers, revision numbers, document status. Control and distribution of documents. Storing, retrieving and updating documents. The change control process, types of change control. Preparation of GMP compliant documents. Compaints: management of complaints and using complaints as a means to improve systems and processes. Responsibilities of the manufacturer, pharmacovigilance, deviation management and CAPA. Introduction to Quality Risk Management.
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Data Integrity
Review of steps to ensure data is accountable, legible, contemporaneously recorded, original or tru copy and accurate.
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Quality Audits
Categories of audits and approaches to auditing. Analysis of the steps involved in auditing manufacturing environments. Audit reports and corrective actions. FDA/HPRA audits.
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Laboratory Management Systems
Laboratory Accreditation, Method Validation, LIMS, Calibration requirements, INAB, Comparison of ISO 17025 requirements and GLP requirements.
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Process Control and Release Strategies
Identification of critical process parameters. Methods of monitoring processes. Process Analytical Technology. Product Release requirements, Real Time Release requirements.
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Training
The importance of training in controlled manufacturing environments. GMP requirements of training. Different training methods. Maintenance of training records.
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| Assessment Breakdown | % |
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| Course Work | 100.00% |
| Course Work |
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| Assessment Type |
Assessment Description |
Outcome addressed |
% of total |
Assessment Date |
| Short Answer Questions |
6 online assessments |
1,2,4,5,6,7 |
60.0 |
Every Second Week |
| Practical/Skills Evaluation |
4 Work shop assignments |
2,3,5,6 |
40.0 |
Sem End |
| No End of Module Formal Examination |
| Reassessment Requirement |
Coursework Only
This module is reassessed solely on the basis of re-submitted coursework. There is no repeat written examination.
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The institute 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 |
Introduction to module and conclusion |
3.75 |
Twice per semester |
0.50 |
| Directed Learning |
Online recorded presentations, notes and other materials, 10 hours over the semester |
10.0 |
Once per semester |
0.67 |
| Lecturer-Supervised Learning (Contact) |
4 x 3 hour workshops |
3.0 |
Every Third Week |
1.00 |
| Directed Learning |
6 x 1 hr industry webinars |
1.0 |
Every Second Week |
0.50 |
| Lecturer-Supervised Learning (Contact) |
Mentoring |
1.0 |
Every Week |
1.00 |
| Independent & Directed Learning (Non-contact) |
Private Study |
3.33 |
Every Week |
3.33 |
| Total Hours |
22.08 |
| Total Weekly Learner Workload |
7.00 |
| Total Weekly Contact Hours |
2.50 |
| Workload: Part Time |
| Workload Type |
Workload Description |
Hours |
Frequency |
Average Weekly Learner Workload |
| Lecture |
Introduction to module and conclusions |
3.75 |
Twice per semester |
0.50 |
| Directed Learning |
Online recorded presentations, notes and other materials, 10 hours over the semester |
10.0 |
Once per semester |
0.67 |
| Lecturer-Supervised Learning (Contact) |
4 x 3 hour workshops |
3.0 |
Every Third Week |
1.00 |
| Directed Learning |
6 x 1 hour industry webinars |
1.0 |
Every Second Week |
0.50 |
| Lecturer-Supervised Learning (Contact) |
Mentoring |
1.0 |
Every Week |
1.00 |
| Independent & Directed Learning (Non-contact) |
Private Study |
3.33 |
Every Week |
3.33 |
| Total Hours |
22.08 |
| Total Weekly Learner Workload |
7.00 |
| Total Weekly Contact Hours |
2.50 |
Module Resources
| Recommended Book Resources |
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- B N Cooper 2017, Good Manufacturing Practices for Pharmaceuticals: GMP in Practice, 1st Ed., CreateSpace Independent Publishing Platform [ISBN: 1974006328]
- Priscilla Browne 2017, GMP and GXP Guide for Engineers: Quality, Compliance and Inspection, 1st Ed., CreateSpace Independent Publishing Platform [ISBN: 1974426270]
| | This module does not have any article/paper resources |
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| Other Resources |
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- Website: Food and Drug Administration
- Website: Health Products Regulatory Authority
- Website: National Standards Authority of Ireland
- Website: Medicines and Healthcare Products
Regulatory Agency (UK)
- Website: Eudralex
- Website: Medical Devices Regulatory Framework
(EU)
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Module Delivered in
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