This module covers the science and practice of validation, as it applies within the pharmaceutical and medical device sectors, with particular focus on computerised/automated systems. The use of risk management as part of the validation process is also covered.

1. Explain the regulatory basis for validation and the role of validation within Good Manufacturing Practice.

2. Describe the major steps involved in the validation of critical pharmaceutical and medical device manufacturing operations, including equipment, process, cleaningand test method validation.

3. Appreciate the growing dependence on automated systems, software anddata in a manufacturing context and the importance of equipment and automated system validation and data integrity.

4. Prepare a validation / qualification documentand complete risk assessmentexercises in accordance with regulatory guidelines and industry best practice.

5. Recognise opportunities for more sustainable practice within industry,specifically with respect to electronic record and data management.

This module aims to provide the student with the knowledge to understand and manage clean room environments.

1. Explain the principles of cleanroom design and construction

2. Apply standards and regulations in cleanroom operation.

3. Describe the requirements for monitoring and testing the cleanroom environment.

4. Identifysources of contamination and implement control systems

This module reviews the latest European and US regulations for pharmaceutical and medical devices. The quality system standards/regulations/guidelines are reviewed for Europe and the US and the auditing approaches used to demonstrate compliance are explored.

1. Evaluate the EU and FDA Quality System requirements for medical devices and pharmaceuticals

2. Interpret themarketing authorizationand regulatory pathwaysfor pharmaceuticals and medical devicesin the EU and the US.

3. Explain the principles,requirements and practices of compliance auditing

4. Detail a system for investigation of non-conformances, identification of root cause and corrective / preventive actions.
5. Participate in an audit, identifying any non-conformances and generation of an audit report