+4474648-84564 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 words Total : 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.
