FDA Compliance 2011 - Risk Management in (FDA) Quality and Manufacturing Areas ? Understanding What the Regulators Expect and Working it to your Advantage

This Risk Management training will provide valuable assistance on how risk management can be incorporated into many of your operations in the GMP world. It includes detailed information on what the regulators will be looking for as well as how you can use it to your advantage to streamline your operations yet remain compliant.

This webinar will provide valuable information on the value of Risk Management in pharmaceutical, device and biotechnology operations and meeting agency expectations. It includes rationales for the use of the techniques in a variety of scenarios from plant design and construction through operations in the plant such as setting up monitoring, conducting investigations and validation planning and execution. It describes the components of the processes including how to initiate risk management, risk assessment and risk control, implementation and review of remediation and feedback linking into continuous improvement.

The presentation will highlight the importance of complete documentation, not just to satisfy the agency during product review and inspection, but also as a permanent record for decision making in the future. The speaker will describe the importance of clear communication to assure focused decision making and buy off in the organization.