Validation

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, cleaning and test method validation.

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

4. Prepare a validation / qualification document and complete risk assessment exercises 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.