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Technology Transfer


Lecturers Name:Paula Kearney & John O’Brien
Subject:Technology Transfer 
Assignment Title:Transfer of a Covid vaccine from Development into an existing Biopharmaceutical company which has all associated equipment to manufacture this product.  
Assignment Format: Word Document                                                                                       Percentage: 100%  
Instructions: This assignment is broken into 3 parts (see marking scheme). Consideration needs to be given to the following: Hiring and training staff to give operations more support and flexibility.Modifying facilities for production and re-prioritizing capacity.Exchanging technology to enable rapid facility, equipment and process design planning.  Investing at risk in order to quickly produce as many doses of a vaccine as possible e.g. Ordering materials.  
Q1. Design a Validation Master Planfor the transfer of a vaccine into an existing biopharmaceutical company which manufactures similar products.   Q2. Based on your plan outline all aspects of the change control (parent and child records) for each department.   Q3. Describe the plan you would put in place for Operational readiness.40 Marks                     40 Marks             20 Marks
Word/Page count:3000 wordsTotal :100% of marks for TT module
Submission details:Submit softcopy of assignment on Moodle by: 30 Nov 2021 The document will be submitted to Turnitin.

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