VALD06001 2016 Validation Principles

General Details

Full Title
Validation Principles
Transcript Title
Validation Principles
Code
VALD06001
Attendance
N/A %
Subject Area
VALD - Validation
Department
MENG - Mech. and Electronic Eng.
Level
06 - NFQ Level 6
Credit
05 - 05 Credits
Duration
Semester
Fee
Start Term
2016 - Full Academic Year 2016-17
End Term
9999 - The End of Time
Author(s)
Mary Nolan, Fiona Donovan
Programme Membership
SG_EVALI_S06 201900 Level 6 Special Purpose Award in Engineering in Validation Technologies
Description

This module introduces the student to the area of validation. The student will learn the reasons behind the stringent validation requirements in the pharmaceutical, biopharmaceutical and medical device sectors. The student will become familiar with the actual regulatory requirements for validation activities and understand the expectations from both an EU and US point of view.

Learning Outcomes

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

1.

1. Understand and discuss the reasons for strict regulatory requirements in relation to validation.

2.

2. Interpret the requirements of Eudralex Volume 4 Annex 15

3.

3. Understand the different stages of a validation project and what happens at each stage

4.

4. Discuss process validation requirements and the lifecycle approach

5.

5. Interpret the different requirements which are necessary for a User Requirement Specification and how this links to the success of a validation project

6.

6. Explain the validation categories

Teaching and Learning Strategies

Teaching will be online by means of an interactive weekly online lecture. Lectures will be recorded for those who cannot attend the live lecture.

Module Assessment Strategies

Assessment will consist of both continuous assessment undertaken during the semester and an end of semester final written exam.

Repeat Assessments

Students will be able to sit a repeat final examination in the event of a failed exam.

Students who do not submit C/A may be required to submit C/A before passing the module.

Indicative Syllabus

History of validation requirements: Explain the evolution of validation requirements. give examples of incidents which have resulted in strict requirements of today.

Types of validation: Explain types of validation deemed acceptable by regulatory authorities and when each is relevant.

Annex 15: Explain the concept of Annex 15 and what the specific regulatory requiirements are for different types of validation

Stages of a validation project: URS, FDS, DQ, IQ, OQ and PQ What happens at each stage

Validation documentation: Validation Master Plan (and content), Validation protocols, Validation Summary Reports

Riak Assessment: FMEA and its relevance to validation projects

 

 

 

Coursework & Assessment Breakdown

Coursework & Continuous Assessment
40 %
End of Semester / Year Formal Exam
60 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Multiple choice moodle quiz Continuous Assessment Multiple Choice 10 % Week 5 1,2,3,4,5,6
2 Multiple choice moodle quiz Continuous Assessment Multiple Choice 10 % Week 8 1,2,3,4,5,6
3 Essay type assignment Continuous Assessment Essay 20 % Week 5 1,2,3,4,5,6

End of Semester / Year Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Final written exam Final Exam Closed Book Exam 60 % End of Semester 1,2,3,4,5,6
             
             

Online Learning Mode Workload


Type Location Description Hours Frequency Avg Workload
Lecture Online Online Lecture weekly 1 Weekly 1.00
Independent Learning Not Specified Required independent learning 4 Weekly 4.00
Total Online Learning Average Weekly Learner Contact Time 1.00 Hours

Required & Recommended Book List

Recommended Reading
1998 Validation Fundamentals Interpharm/ CRC

How to, What to, When to validate

Recommended Reading
2003-03-27 Pharmaceutical Process Validation: An International (Drugs and the Pharmaceutical Sciences) CRC Press
ISBN 8126541040 ISBN-13 9788126541041

The third edition of this text contains additional chapters which cover troubleshooting procedures, validation in contract manufacturing and current harmonization trends.

Recommended Reading
2007-09-25 Validation of Pharmaceutical Processes, 3rd Edition CRC Press
ISBN 0849370558 ISBN-13 9780849370557

Completely revised and updated to reflect the significant advances in pharmaceutical production and regulatory expectations, this third edition of Validation of Pharmaceutical Processes examines and blueprints every step of the validation process needed to remain compliant and competitive. The many chapters added to the prior compilation examine validation and six sigma system design; the preparation of aseptic and non-aseptic pharmaceutical products; active pharmaceutical ingredient and biotechnology processes, computerized systems; qualification and cleaning of equipment; analytical methods, calibration and certification. As the industry's leading source for validation of sterile pharmaceutical processes for more than 10 years, this greatly expanded is a comprehensive analysis of all of the fundamental elements of this arena with practical solutions for every pharmaceutical and bio-pharmaceutical production process.

Presenting theoretical knowledge and applied practical considerations, this title

  • provides an in-depth discussion of recent advances in sterilization
  • identifies obstacles that may be encountered at any stage of the validation program, and suggests the newest and most advanced solutions
  • explores distinctive and specific process steps, and identifies critical process control points to reach acceptable results
  • blends the use of theoretical knowledge with recent technological advancements to achieve applied practical solutions
  • Module Resources

    Other Resources

    Eudralex online http://ec.europa.eu/health/documents/eudralex/vol-4/index_en.htm

    FDA http://www.fda.gov/

    EMA http://www.ema.europa.eu/ema/