Risk Management for Pharma and Biopharma Professionals

Risk management is becoming increasingly important to drug and medical device development and ensuring compliance with regulatory expectations.  There are now numerous pharmaceutical guidelines covering risk management including ICH Q9, ICH GCP R2 and R3, drug and device risk based guidance during a pandemic, regulatory risk based approaches, and FDA Risk-based monitoring of Clinical Investigation questions and answers guidance. 

This essential course will explain the importance of using risk management techniques in drug and device development to comply with the latest focus on inspection in this area. It will show you how risk management can improve the quality of your development projects and demonstrate the importance of using risk analysis and risk management techniques in the pharma, biopharma and medical device industries. You will learn how to identify, evaluate and implement specific risk-based techniques for risk management, including a quality management framework.

The course will enable you to develop quality risk management principles applicable to pharma, biopharma and device development, as well as to identify and share best practices for risk management tools and approaches.