REGU09022 2019 Regulation, Risk and Compliance

General Details

Full Title
Regulation, Risk and Compliance
Transcript Title
Regulation, Risk and Complianc
Code
REGU09022
Attendance
N/A %
Subject Area
REGU - Regulatory Affairs
Department
LIFE - Life Sciences
Level
09 - NFQ Level 9
Credit
05 - 05 Credits
Duration
Semester
Fee
Start Term
2019 - Full Academic Year 2019-20
End Term
9999 - The End of Time
Author(s)
Mary Butler
Programme Membership
SG_SBCQV_E09 201900 Level 9 Certificate in Science in CQV Commissioning, Qualification and Validation for Biologics Manufacturing
Description

This module aims to provide students with an understanding of the main regulations and regulatory bodies associated with biopharmaceutical manufacturing and how they translate into this environment. It also provides students with the application of the validation concepts and how risk management is an integral part of this.

Learning Outcomes

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

1.

Demonstrate an understanding of the global regulatory framework for biotechnology derived products
 

2.

Discusss the nature and production of biotechnology products affects quality, safety and efficacy
 

3.

Differentiate the applications of EU & US regulations for biopharmaceutical marketing authorisations
 

4.

Categorise the principal risks associated with the manufacture of modern biopharmaceuticals and tools to evaluate them

5.

Critically evaluate the main steps involved in the validation of upstream (cell culture processing) and downstream (protein purification) processes as well as cleaning, sterilisation and viral control technologies in the manufacture of biopharmaceuticals.

6.

Engage in and demonstrate independent learning as well as communicate effectively as an Individual and or a member of a team

Teaching and Learning Strategies

This module will be taught using on‑line lectures. A range of Computer‑Aided Learning (CAL) packages are also used to support this module (e.g. Moodle,Adobe Connect, Panopto, Camtasia). Students are provided with electronic materials for self‑assessment and preparation for assessments/assignments. Self‑directed, student‑centred, independent learning is a core aspect through completion of module coursework.

Module Assessment Strategies

The assessment approach for this module will be 100% continuous employed including some of the following: Enquiry based Projects, Assignments/mini projects including Viva/Presentation Short-form assessment exams incl. MCQs, Short answer and Long Answer Questions.
 

Repeat Assessments

Students will have opportunities to re-submit work  as agreed with their lecturer.

Indicative Syllabus

Section 1 Legislation

Overview of the EMA, FDA, and ICH. Introduction to Clinical Trials and Drug Development (CTA, IMPD, IND)
 
Section 2 Biologics
TSE risks Advanced Therapies Biosimilars QBD FDA & EU GMP regulations for pharma/biopharma manufacture
 
Section 3  Validation

Validation Validation Master Plan, validation life cycle, and risk management Upstream and Downstream, Cleaning and Viral Clearance

Section 4 Risk

Risk Identification, Risk Assessment and Risk Management for Biopharmaceutical Manufacture (ICH Q9).

Coursework & Assessment Breakdown

Coursework & Continuous Assessment
100 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 MCQ 1 Continuous Assessment Multiple Choice 10 % Week 5 1,2
2 MCQ 2 Continuous Assessment Multiple Choice 10 % Week 9 3,4
3 End of Semester Assessment Continuous Assessment Assignment 20 % Week 12 1,2,3,4,5
4 Project & Viva Project Closed Book Exam 40 % Week 12 1,2,3,4,5,6
5 Gp Project Project Group Project 20 % Week 11 2,3,4,5,6

Part Time Mode Workload


Type Location Description Hours Frequency Avg Workload
Lecture Online Lecture 2 Weekly 2.00
Independent Learning Not Specified Self Study 7 Weekly 7.00
Total Part Time Average Weekly Learner Contact Time 2.00 Hours

Required & Recommended Book List

Required Reading
2007-09-25 Validation of Pharmaceutical Processes, Third 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

Required Reading
2013-04-25 Pharmaceutical Biotechnology John Wiley & Sons
ISBN 9781118685754 ISBN-13 111868575X

Pharmaceutical Biotechnology offers students taking Pharmacy and related Medical and Pharmaceutical courses a comprehensive introduction to the fast-moving area of biopharmaceuticals. With a particular focus on the subject taken from a pharmaceutical perspective, initial chapters offer a broad introduction to protein science and recombinant DNA technology- key areas that underpin the whole subject. Subsequent chapters focus upon the development, production and analysis of these substances. Finally the book moves on to explore the science, biotechnology and medical applications of specific biotech products categories. These include not only protein-based substances but also nucleic acid and cell-based products. introduces essential principles underlining modern biotechnology- recombinant DNA technology and protein science an invaluable introduction to this fast-moving subject aimed specifically at pharmacy and medical students includes specific product category chapters focusing on the pharmaceutical, medical and therapeutic properties of numerous biopharmaceutical products. entire chapter devoted to the principles of genetic engineering and how these drugs are developed. includes numerous relevant case studies to enhance student understanding no prior knowledge of protein structure is assumed

Module Resources

Journal Resources

Pharmaceutical Drug Regulatory Affairs Journal
 

URL Resources

www.FDA.gov


https://www.ema.europa.eu/en


www.hpra.ie


www.ich.org


https://ec.europa.eu/health/documents/eudralex_en


https://www.edqm.eu/

Other Resources

None