REGU08006 2017 Validation and Calibration

General Details

Full Title
Validation and Calibration
Transcript Title
Validation and Calibration
Code
REGU08006
Attendance
N/A %
Subject Area
REGU - Regulatory Affairs
Department
LIFE - Life Sciences
Level
08 - NFQ Level 8
Credit
05 - 05 Credits
Duration
Semester
Fee
Start Term
2017 - Full Academic Year 2017-18
End Term
9999 - The End of Time
Author(s)
Mary Butler, Stephen Daly
Programme Membership
SG_SMEDI_L08 201900 Higher Diploma in Science in Science in Medical Device Regulatory Affairs and Quality SG_SMEDI_E08 201900 Certificate in Science in Medical Device Regulatory Affairs and Quality
Description

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.

Learning Outcomes

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

1.

Interpret and explain the relevance of calibration within a GMP and Quality Assurance environment.

2.

Describe the various metrological requirements from quality characteristics through instrument selection, evaluation and ongoing calibration

3.

Outline the properties of a good measurement management system and how it links to validation

4.

Interpret the key elements in a systematic approach to validation with an emphasis on medical device manufacture

5.

Critique risk analysis and evaluation and how it relates validation

6.

Source and interpret the industry standard guidelines in use for validation within a GMP environment.

7.

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 Assessments

Repeat assignments will be given.

Indicative Syllabus

The following is a summary of the main topics included in this particular module: 

  1. 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

Coursework & Continuous Assessment
100 %

Coursework Assessment

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


Type Location Description Hours Frequency Avg Workload
Online Lecture Online Lecture 2 Weekly 2.00
Independent Learning Online Independent Learning 5 Weekly 5.00
Total Online Learning Average Weekly Learner Contact Time 2.00 Hours

Required & Recommended Book List

Recommended Reading
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.

Module Resources

Non ISBN Literary Resources

as per booklist

URL Resources
  • Website: Food and Drug Administration

http://www.fda.gov

 

http://www.ich.org

 

 

  • Website: EU GMP Guidelines

http://ec.europa.eu/health/documents/eud ralex/vol-4/index_en.htm

 

  • Website: The International Medical Device Regulators Forum

http://www.imdrf.org/

 

  • Website: The National Standards Authority of Ireland

http://www.nsai.ie

 

  • Website: Irish National Accreditation Board

http://www.inab.ie