Biochemical Engineering|Bioengineering|Biomedical Engineering and Clinical Engineering|Biotechnology|Drug Design

VALIDATION|REGULATIONS (FDA|EMA|MHRA|ICH)|QUALITY BY DESIGN|PAT|DOE|ANALYTICAL TECHNOLOGIES|

This module is designed to support those involved in bioprocess development with current validation knowledge and methodology. Students will be able to...

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: • Communicate with validation experts • Understand what is required by the regulatory authorities for compliance including future direction of the regulations • Understand the implications of validation for process development and pre/post-approval process changes • Familiarise with current validation practice across the bioprocess industry • 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.

The internship provides supervised work experience in the &#039;real world&#039; of a museum or similar institution. During the first year of the MSc programme...

The internship provides supervised work experience in the 'real world' of a museum or similar institution. During the first year of the MSc programme each student discusses his/her career aspirations with the module tutors, and starts to plan his/her professional development. An internship is chosen and structured to enable the student to gain a range of relevant experience. 

There are well established internship agreements with major museums such as the British Museum, the Museum of London, the Horniman Museum, and the Pitt Rivers Museum as well as with institutions such as English Heritage and the National Trust.