In this seminar, we will discuss a comprehensive assessment of a business to establish its assets and liabilities to evaluate commercial potential. We will compare actual performance with potential desired performance in our case study weather to transfer or invest in keeping medical device operations in-house or decide to transfer operation to a contract manufacturer (CMO) from a successful case study. What are the options and next steps to transferring it to the right internal facility or CMO? It will also cover developing a Master Validation Plan, which could be used as a Master Project Plan. It will not only cover the Master Validation Plan, but you will also learn how to develop and write the Protocols (IQ, OQ, PQ) to execute the validations as part of the Validation Plan to meet FDA regulations.
Every medical device company (OEM) and their CMO’s must meet certain standards for validation of all its processes, manufacturing operations, infrastructure, transfer plans, facilities, and clean rooms. These standards apply for OEM’s and CMO’s. This seminar will instruct the participant on how to develop the Master Validation Plan and Protocols that will show how to meet the FDA and ISO standards for validations. This webinar will provide a step-by-step procedure for all medical device companies and their suppliers that are in need of developing a plan for product, equipment, processes and facilities.