Overview of Tech Transfer in the Vaccine Industry: Part 1
Learning Objectives:
Upon completion of the course, participants will be able to:
- Explain the types of tech transfer, and the elements involved in a tech transfer.
- Describe key activities for a tech transfer agreement.
- Create a tech transfer plan incorporating relevant process types and defined success outcomes.
- Decide on stakeholders and build a project management team to execute a tech transfer.
Overview of Tech Transfer in the Vaccine Industry: Part 2
Learning Objectives
Upon completion of the course, participants will be able to:
- Measure the outcomes of the tech transfer using the tools explained to decide the success of a tech transfer.
- List the possible challenges and risks associated with the tech transfer plan and design a risk assessment matrix.
Teacher: Erlyani Hamid, Natalie Yaseen
Regulatory Perspectives in Tech Transfer
Learning Objectives:
Upon completion of the course, participants will be able to identify the key elements for preparation of effective regulatory strategies which would enable successful tech transfer, including the following:
- State regulators’ expectations.
- Explain expectations of the internal regulatory affairs team.
- Compare regulatory pathways or actions enabling tech transfer, including current trends and challenges.
Teacher: Erlyani Hamid, Natalie Yaseen
Facility Fit Assessment (FFA)
Learning Objectives
Upon completion of the course, participants will be able to describe the methodology to perform a Facility Fit Assessment.
Tech Transfer of Typical Unit Operations
Learning Objectives:
Upon completion of the course, participants will be able to:
- Explain the typical various unit operations in upstream and downstream processing.
- State the purpose of the typical unit operations.
- List of important elements for process tech transfer.
- State examples of typical Critical Process Parameters/Key Process Parameters (CPP/KPP), critical steps, process controls, samples points that are required in a tech transfer (from sending unit to receiving unit).
- Provide examples of and list typical documents to be transferred
- Prepare an example of risk assessment accompanying sending and receiving units for TT.
Teacher: Erlyani Hamid, Natalie Yaseen
Biophysical and Biochemical Assay Transfer
Learning Objectives:
Upon completion of the course, participants will be able to:
- Use a sample checklist to create an appropriate gap analysis checklist.
- Identify and create a transfer strategy.
- Define and build a master transfer plan/protocol.
- Define and build method specific transfer plan/protocol with clearly defined transfer criteria responsibilities and deviation handling.
- Perform execution (of what?), evaluate and report execution data.
- Compare results against criteria in 4th point in method specific report.
- Define and build a master transfer report.
- Explain common pitfalls of assay transfer.
Teacher: Erlyani Hamid, Natalie Yaseen