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Description
This module is designed to support those involved in bioprocess development with current validation knowledge and methodology. Students will be able to determine the type of information required to validate a process and benchmark this across the industry. Upon completion of the course, a student should be able to: 鈥� Communicate with validation experts 鈥� Understand what is required by the regulatory authorities for compliance including future direction of the regulations 鈥� Understand the implications of validation for process development and pre/post-approval process changes 鈥� Familiarise with current validation practice across the bioprocess industry 鈥� Understand the role of validation and quality control in ensuring public protection Assessment is via the preparation of a Validation Master Plan (~2500 words) for a specified process change in the production of a mAb therapeutic . Contents to include Executive Summary, Process Specification and Flow Sheets, Impact (CQAs and CPPs), Validation Tasks, Scheduling and Conclusions. A detailed mark scheme is provided. Students receive lectures from external experts in validation and participate in workshops where they have the opportunity to present on validation strategies and receive feedback from experts.
Module deliveries for 2024/25 academic year
Last updated
This module description was last updated on 8th April 2024.
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