REGU08006 2017 Validation and Calibration
This module introduces the regulatory requirement for calibration and validation within a GMP environment, their benefits to an organisation and the tools required for effective implementation This module will prepare students to undertake different validation roles and will equip the student to complete many validation activities within their organisation. The impetus for the development of this module has emerged from industry needs and the course content has been designed to meet this industry need. This module covers the core aspects of interpreting and/or setting quality characteristics and their verification through appropriate calibrated Inspection, Measurement and Testing processes. The module traces the metrological requirements from quality characteristics through instrument selection, evaluation and on-going calibration so that the student is fully aware of the purpose and operation of a good measurement management system.
On completion of this module the learner will/should be able to;
Interpret and explain the relevance of calibration within a GMP and Quality Assurance environment.
Describe the various metrological requirements from quality characteristics through instrument selection, evaluation and ongoing calibration
Outline the properties of a good measurement management system and how it links to validation
Interpret the key elements in a systematic approach to validation with an emphasis on medical device manufacture
Critique risk analysis and evaluation and how it relates validation
Source and interpret the industry standard guidelines in use for validation within a GMP environment.
Outline elements of validation documentation and understand the regulatory requirements and the use of risk management tools in making regulatory decisions.
Teaching and Learning Strategies
Content will be delivered primarily via online and blended methods. Additional lecturing, as required, may be provided by outside specialists and practitioners. Learning strategies including evidence based and enquiry based learning also will be used. Resources used will include Moodle, Adobe connect, Panopto, and other multimedia such as youtube, webinars, literature databases.
Module Assessment Strategies
The assessment approach for this module will be 100% Continuous Assessment with a range of assessment methods employed including some of the following: short-form assessment exams incl. MCQ's, project assignments, group reports and essays and oral presentations.
Repeat assignments will be given.
The following is a summary of the main topics included in this particular module:
- Quality characteristics, measurement and testing, instrument selection, evaluation, ongoing calibration and frequency, measurement management systems, Test Accuracy Ratios, Equipment qualification, Validation Master Plan, Application of risk Assessment, Application to professional practice by use of relevant case studies.
2. Application of current Good Manufacturing Practices to the validation of equipment, plant, utilities, processes and procedures in the pharmaceutical and medical device industries. The use of risk assessment techniques in validation.
Coursework & Assessment Breakdown
|Title||Type||Form||Percent||Week||Learning Outcomes Assessed|
|1||Technical report||Continuous Assessment||Written Report||20 %||Week 3||1,6,7|
|2||Essay||Continuous Assessment||Essay||30 %||Week 6||2,3,5|
|3||MCQ/LAQ||Continuous Assessment||Multiple Choice||15 %||Week 10||4,5|
|4||Critical evaluation||Continuous Assessment||Written Report||25 %||Week 8||4,6,7|
|5||Presentation||Continuous Assessment||Oral Exam||10 %||Week 13||3,6|
Online Learning Mode Workload
|Independent Learning||Online||Independent Learning||5||Weekly||5.00|
Required & Recommended Book List
2008-04 GAMP 5: A Risk-based Approach to Compliant Gxp Computerized Systems ISPE
ISBN 1931879613 ISBN-13 9781931879613
The new GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems provides pragmatic and practical industry guidance that aims to achieve compliant computerized systems that are fit for intended use in an efficient and effective manner, while also enabling innovation and technological advance. The revised Guide describes a flexible risk-based approach to compliant GxP regulated computerized systems, based on scalable specification and verification. A robust quality risk management process based on ICH Q9 principles is central to the approach. GAMP 5 also contains new information on outsourcing, electronic batch recording, end user applications (such as spreadsheets and small database applications), and patch management.
as per booklist
- Website: Food and Drug Administration
- Website: HPRA
- Website: International Conference for Harmonization
- Website: EU GMP Guidelines
- Website: The International Medical Device Regulators Forum
- Website: The National Standards Authority of Ireland
- Website: Irish National Accreditation Board