Introduce Quality Risk Management (QRM) as a proactive approach to ensuring quality and safety in pharmaceutical and dietary supplement manufacturing. Explore the core principles of QRM, emphasizing the use of scientific knowledge and experience in evaluating risks, and the proportional allocation of resources based on risk level. Understand the four main stages of the risk management process: risk assessment, risk control, risk communication, and risk review. Delve into the three components of risk assessment: hazard identification, risk analysis (considering likelihood, severity, and detectability), and risk evaluation.

This episode also discusses the two main strategies of risk control: risk reduction (through actions like improved sanitation and material handling) and risk acceptance (for risks that cannot be further reduced or are cost ...