Can your organization demonstrate an effective risk management program when your next FDA inspection occurs? Without a comprehensive risk management program, your organization is open to FDA inspection and submission problems as well as possible enforcement action. Risk analysis has been an essential requirement of the European Union (EU) directives for medical devices. Get the latest information on risk management concepts and practices for the medical device industry.
Learn how to manage a process associated with the identification, analysis, evaluation, and control of different types of risk before production begins. Class discussions cover the use of failure mode and effects analysis (FMEA) and fault tree analysis (FTA) as methods of conducting risk analysis, including predictions and determining approaches to reliability and safety analysis. Also covered is the application of these tools to product design and manufacturing processes.
To receive more in-depth training, precede this course with Process Validation Principles and Protocols (course code PVF).
Bonus: Register for both courses and save $295 off of the combined total!