Topics covered in this module include an orientation to GMP, EU and US regulations, documentation requirements, conducting investigations, CAPA, auditing, QC (quality control) laboratory operations and management responsibilities. Upon completion, students will be able to apply these GMP practices in regulated industries.

1. Demonstrate a basic grounding in the fundamentals of GMP, its regulatory basis and the critical role these GMP practices play in ensuring that pharmaceutical products and medical devices are consistently safe and effective, and are produced to high quality standard.
2. Describe the roles of QA and QC within a Quality Management system and their location within the process flow. Communicate examples of QA/QC responsibilities relevant to various processes.
3. Describe the roles of all personnel, training, engineering, maintenance, production and contractors within a GMP organisation.
4. Explain and illustrate the concepts of proper documentation utilized in a GMP environment and its function in traceability investigations and formal contracts.
5. Participate in the use of the tools and methodologies that provide an approach for developing corrective and preventive actions that address and limit manufacturing failures.
6. Describe key principles that ensure the validity of all data generated within a GMP environment.

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 regulatory point of view.

1. 1. Comprehendand 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

This module explores the role of metrology in modern manufacturing and the management and control of measurement systems. It covers all aspects of measurement management from interpretation of specifications, determination of metrological and calibration requirements to evaluation and ongoing calibration and maintenance.

1. Specify suitable measurement instruments and standards.
2. Describe the International System of Units (SI) and the seven base units

3. Identify the essential components of metrology traceability

4. Recognise various national and international organisations from which we get many metrology references, resources and standards

5. Describe and define measurement assurance philosophy

6. Explain the concepts of measurement and metrology

This module builds on the knowledge gained in validation principles. This module explains how validation activities are undertaken from a practical point of view. It covers Cleanroom and Cleaning validation, analytical method validation and includes an introduction to computer systems validation and sterilisation validation.

1. 1.Define how validation principles are applied to actual validation projects
2. 2. Actively participate in completing different validation projects in pharma/ biopharma and medical device companies such as cleanroom validation, cleaning validation, computer systems validation and sterilisation validation projects
3. 3. Understand the sequence of events necessary for a successful validation project
4. 4.Evaluate the importance of cleaning to the organisation and discusshow a cleaning validation project can be undertaken.
5. 5. Understand the importance of analytical method validation and what factors must be considered when validating an analyticalmethod.

This module aims to provide students with an introductory knowledge and understanding of legislation and Regulatory affairs in EU and US with a particular focus on Biopharmaceuticals and Biologics

1. Demonstrate they have a knowledge and understanding of the main regulatory institutions in the EU, USA, and Rest of World and their workings
2. Demonstrate they have a knowledge and understanding of the ICH and regulatory harmonisations.
3. Develop an understanding of the Drug development/Clinical Trial Process with the and how it interacts with the Drug approval process for both Europe and USA.
4. Understand the various principles and practices involved in the control and regulation of the medical device industry both in Europe and the USA
5. Demonstrate a knowledge of the different roles and responsibilities to ensure legal marketing, manufacture, distribution and sale of drugs.
6. Communicate and explain scientific information in relation to regulatory affairs

The learners engage in an independent research project where they use the skills & competencies acquired in the program of study to research an area deemed appropriate by an academic superviser

1. Work independently on a work related project
2. Source literature relevant to the project
3. Become proficient at meeting deadlines within allocated timeframe
4. Interpret and evaluate their findings and make recommendations on this basis
5. Present their work and answer questions following their presentation