How should I go about doing this presentation, any tips of ideas would be greatly appreciated.

Transfer of an OEB level 5 Oral Solid Dose product from pharmaceutical company XYZ to a Contract Manufacturing Organisation

Initiate: Identify a high-end overview of the requirements, gaps and risks involved in the TT from the pharma company to CMO.

• Sending and receiving site information required
• What are the Validation Master Plan (VMP) main areas of focus such as facilities, personnel & cleaning etc
• Identify the potential gaps and risks with the TT in the VMP areas mentioned above

Planning: Discuss the potential gaps and risks in greater detail and propose solutions to address these issues.

• Identifying any possible gaps (Gap analysis) in the information package from the sending site
• Perform a qualitative risk analysis of the TT
• Propose solutions to address the risks and how to avoid/mitigate

Execution: Discuss the importance of why we validate. Outline the key aspects for analytical method transfer.

Close Out: Outline the learning outcomes of the transfer. Review the Process Validation Lifecycle and summarise any actions that a company could implement to keep them in a validated state

Example: Continuous Improvements, continuous sampling, staying regulatory compliant etc.