Quality Risk Management Basics as part of the Quality Management System

This week on Voices in Validation we welcome Lori Richter and Nuala Calnan to introduce a new podcast series on Risk Managment. In this episode we discuss risk and quality management covering some of the basics of QRM, QMS, regulatory guidelines, common shortfalls and mistakes in risk assessments, as well as the importance of building a risk culture. In  subsequent episodes the plan to move on to “deep dives” focused on some of the more intricate and nuanced areas of Risk Management is also introduced.

Links from today's episode:

• ICH Q9 Quality Risk Management Guidance
• Annex 1 Manufacture of Sterile Medicinal Products
• WHO Risk Management Guidance
• European Medicines Agency Risk Management Guidance Format
• European Medicines Agency Risk Management Plans
• National Health Regulatory Authority (NHRA)