CHEN40640 Commissioning & Qualification

Academic Year 2021/2022

This module will provide an introduction into the commissioning of equipment and utilities used in biopharmaceutical and biologic manufacturing facilities. It will equip students’ with the knowledge and skills required to perform commissioning of a biomanufacturing plant, and the equipment related to the biotechnology industry.

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Curricular information is subject to change

Learning Outcomes:

On completion of the module students should be able to:

1. Outline industry regulations and guidelines relating to C&Q
2. Describe key manufacturing technologies used in the biopharmaceutical industry
3. Interpret design documents required for the generation of installation and functional tests
4. Equipment/instrument receipt verification
5. Impact/risk assessments

Indicative Module Content:

1. Outline industry regulations and guidelines relating to Commissioning &Qualification (CQ)
2. Describe key manufacturing technologies used in the Biopharma Industry
3. Interpret design documents required for the generation of installation and functional tests of equipment required for biomanufacturing
4. Equipment/instrument receipt verification
5. Impact/risk assessments

Student Effort Hours: 
Student Effort Type Hours
Lectures

16
Autonomous Student Learning

104
Total

120
Approaches to Teaching and Learning:
Module will be delivered using a mixture of lectures and case-based studies 
Requirements, Exclusions and Recommendations

Not applicable to this module.


Module Requisites and Incompatibles
Not applicable to this module.
 
Assessment Strategy  
Description Timing Open Book Exam Component Scale Must Pass Component % of Final Grade
Continuous Assessment: Details of assignments will be provided at the start of the trimester Varies over the Trimester n/a Graded No

100

Carry forward of passed components
Yes
 
Resit In Terminal Exam
Summer No
Please see Student Jargon Buster for more information about remediation types and timing. 
Feedback Strategy/Strategies

• Feedback individually to students, post-assessment

How will my Feedback be Delivered?

Feedback can be requested by emailing the module teacher.

Name Role
Padraig Williams Lecturer / Co-Lecturer