This training course aims to provide the theoretical and operational knowledge for the design and implementation of a Risk Management system within an assisted reproduction center. During the course, operational and application tools will be provided for the creation of a risk management system within the center, in particular the processes of the PMA center will be analyzed and the risk factors present will be identified, developing an FMEA of the center

Objectives and description of the course:

Quality standards increasingly require centers to implement a system internally aimed at the validation and validation of processes and equipment. However, the legislation is not always clear and it is not always possible to understand which processes must be validated, how to perform the risk analysis and how to correlate the processes to be validated and the risks to be monitored.

For this reason, a methodology called RIVER (Risk Validation EnviRonment) has been developed whose objective is to systematize the development of the risk analysis and the identification of the activities to validate.

During the meeting, participants will be provided with the operational tools to be applied within their own centers.

Participation in the course allows you to meet the continuous training requirements (10 hours per year) for all those who work within the Institutes of Tissues, Transplant Programs and Transfusion Services and to maintain the title of Quality Manager - HQM Research Center ltd. course is ECM accredited.

The course is ECM accredited

All those who manage the quality system must "subject" to the inspections and audits by the regulatory or certification bodies (JACIE, CNT, CNS, CRS, CRT). During this meeting, strategies and operational tools will be provided to be able to effectively prepare for the various inspections and to be able to manage the visit by the competent authority. Tools useful for optimizing the inspection will be provided.

Although the accreditation legislation does not require it, a fundamental element for all organizations is the Quality Manual. In this context, during the training event the path to develop the quality manual of a PMA center will be illustrated, in compliance with the required regulatory requirements .

Implement a staff evaluation and performance management system for staff working within a Transplant Center and a Tissue Institute. During the meeting, operational tools will be provided to be implemented in order to implement a system of qualification and measurement of skills.

During this training course, the topic of organizing a PMA center is explored: how to organize it, how to structure it, how to optimize company functions, how to make it more efficient and productive