Validation for Biopharmaceuticals


This module aims to provide learners with a broad understanding of Validation in the Biopharmacuetical manufacturing context, including Process, Equipment, Cleaning, Automated System and Test Method Validation. 

Learning Outcomes

  1. Investigate the regulatory basis for Validation and the related requirements of the (Bio)pharmaceutical sector from regulatory bodies.

  2. Communicate the key steps required for any Validation and fully comprehend the underpinning principles of specification and verification. 

  3. Participate and add value as a team member in industry on multiple types of Validation projects, e.g. Process, Equipment, Cleaning, Automated System or Test Method Validation. 

  4. Implement the principles of Validation to design and develop Validation documents. 

  5. Apply risk management and change control to Validation activities and Validated entities, e.g. Process, Equipment, Test Methods.

  6. Determine and assess the key validation characteristics of a test method and factors that influence test method variability.

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