The use of Risk Management is a regulatory requirement for manufacturers and distributors in the pharmaceutical industry. First introduced by the FDA with their initiative “Pharmaceutical CGMPs for the 21st Century: A Risk-Based Approach”, risk management is core to the pharmaceutical quality management system (QMS).
However, not all manage risk management as efficiently and as effectively as they should. Used properly, risk management is an extremely useful tool, which benefits both company and customer (patient).
The webinar will:
• Consider when to use risk assessments and when not to
• Review the most commonly used methodology, FMEA (Failure Mode Effects Analysis)
• Discuss FMEA scoring criteria
• Link risk management to change control and other QMS processes
• Explain how to close the loop on implementing the risk management process