REGU08003 2017 Auditing and Compliance

General Details

Full Title
Auditing and Compliance
Transcript Title
Auditing and Compliance
N/A %
Subject Area
REGU - Regulatory Affairs
LIFE - Life Sciences
08 - NFQ Level 8
05 - 05 Credits
Start Term
2017 - Full Academic Year 2017-18
End Term
9999 - The End of Time
Mary Butler
Programme Membership
SG_SMEDI_E08 202100 Certificate in Science in Medical Device Regulatory Affairs and Quality SG_SMEDI_L08 202100 Higher Diploma in Science in Medical Device Regulatory Affairs and Quality SG_SAPPM_K08 202200 Bachelor of Science (Honours) in Applied Industrial Science (Add-On)

This module introduces the regulatory requirement for GMP & compliance auditing, its benefits to an organisation and the tools required by an effective auditor. In addition, it also introduces corrective and preventive action, non conformance reporting and ongoing compliance.

Learning Outcomes

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


Interpret and explain the relevance of auditing as a means of monitoring the production of safe and effective medtech products in a GMP environment.


Describe the various auditing techniques available and the regulatory basis for GMP/compliance auditing


Source, interpret and apply GMP principles to different case scenarios


Role play in a multidisciplinary team of auditors within a GMP environment


Critique the performance of a systematic and independent examination of the effectiveness of a quality system


Identify, assess and analyse breaches of GMP and recommend appropriate corrective and preventive actions


Evaluate non conformance statements and understand the non conformance management process

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. Introduction to GMP and Auditing. (QMS and role of audits in a GMP environment). Self assessment, external audits, vendor audits, QSIT audits.

2. Audit Process- Audit types, techniques, auditor role. Auditing tools, Audit phases, Audit Agendas, Audit preparation, questionnaires and checklists.

3. CAPA systems. Containment, correction, corrective and preventive actions, effectiveness checks.

4. Preparation of non conformance statements. Carrying out audits, reporting.


5. Part 11 Compliance.

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 4 1,6,7
2 Essay Continuous Assessment Essay 30 % Week 7 2,3,5
3 MCQ/LAQ Continuous Assessment Multiple Choice 25 % Week 11 4,5,6
4 Presentation Continuous Assessment Oral Exam 25 % Week 15 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
2011-04-07 Medical Device Design and Regulation Quality Press
ISBN 0873898168 ISBN-13 9780873898164

The intent of this book (MDDR, for short) is to present an introduction to, and overview of, the world of medical device regulation by the United States Food and Drug Administration (FDA), and the relationship of this regulatory scheme to the design and development of medical devices. In providing this information, the book covers the broad range of requirements, which are presented within eight major topics: background and regulatory environment, device design control, nonclinical testing, clinical testing, marketing applications, post-market requirements, quality systems/GMPs, and compliance/enforcement. This book provides students and professionals in the medical device industry with a road map to the regulation of medical devices. It provides a broad understanding of the breadth and depth of medical device regulation by collecting in one textbook coverage of the regulatory scheme for medical devices in terms that are suitable for engineers, scientists, and healthcare providers. The vast amount of information available on the subject is distilled into a concise and coherent presentation. There also are problems and projects at the end of each chapter. In addition to the usual questions requiring specific answers, the projects include the drafting of a device control plan, the development of a nonclinical test procedure, the resolution of a recall, the response to a Warning Letter, and the creation of a CAPA for a device deficiency. A solutions manual for these exercises is available to teachers who adopt the textbook for classroom use. Medical Device Design and Regulation (MDDR) also makes available over 100 complimentary live hyperlinks to web pages with additional relevant information, and offers users the opportunity to join and participate in the MDDR Users Group on LinkedIn.

Recommended Reading
2002-10-28 Quality Audits for Improved Performance, Third Edition ASQ Quality Press

Perfect for anyone charged with implementing a quality audit program or those performing the audit, this book is an ideal reference on the established techniques of quality auditing. This third edition serves as a guide to learning and applying the basics of quality auditing, and expands on the basic auditing principles by showing how the quality audit can be used to improve business performance. This new edition includes:

- An expanded background and history of quality auditing
- A general model for auditing any quality management system
- Added information on process audits and the system-process-product relationship
- Auditor competencies and qualifications
- An explanation of audit reports and the role of the auditor after the report
- New material on remedial and corrective action
- Example audit procedures and a glossary of auditing terms

Author Dennis Arter addresses both internal and supplier auditing as it relates to any quality management system, including ISO 9001, GMP, automotive, and others. He provides supportive examples and checklists throughout the text to help make this book the best single-source guide on the subject. Quality practitioners, registrars, and those preparing for the ASQ Certified Quality Auditor (CQA) exam will find it to be an invaluable reference.

Module Resources

Non ISBN Literary Resources

as per book list