How should I go about doing this presentation, any tips of ideas…
Question Answered step-by-step How should I go about doing this presentation, any tips of ideas… 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 requiredWhat are the Validation Master Plan (VMP) main areas of focus such as facilities, personnel & cleaning etcIdentify the potential gaps and risks with the TT in the VMP areas mentioned abovePlanning: 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 sitePerform a qualitative risk analysis of the TTPropose solutions to address the risks and how to avoid/mitigateExecution: 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 stateExample: Continuous Improvements, continuous sampling, staying regulatory compliant etc. Business Management Project Management Share QuestionEmailCopy link Comments (0)
