Quality Risk Management (QRM) principles require the evaluation of risk to quality based on scientific knowledge and the protection of the patient. Regulators expect that Quality Risk Management (QRM) is inherently built into the backbone of the Quality Management System (QMS) by using both formal and informal risk tools based on ICHQ9. The application and the complexity of risk management tools need to be appropriate to the timing of the risk event, the level of risk and the elements of the QMS under scrutiny, and the overall approach should be defined in a formal Risk Management Plan (RMP). To date the application of ICHQ9 is evident in risk based approaches to commissioning and qualification, but to a lesser extent holistically throughout the product lifecycle.
Through interactive workshops, this course will explain and apply the key principles of QRM programs that need to include Quality Systems elements (ICH Q10) within the product/system lifecycle, including but not limited to:
This course will dive into specific strategies and discussions on important elements of QRM such as defining the criteria for risk ratings and risk mitigation requirements; the importance and necessity of tracking and monitoring the outputs of risk assessments; and how to use risk assessment outputs for trending and process improvement.
Immediately apply the course objectives using the complimentary copy of the ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification and the ICH Q8(R2), ICH Q9 and ICH Q10 booklets.
NOTE: It is strongly recommended that participants be familiar with basic concepts of ICH Q8(R2), ICH Q9 and ICH Q10 and have a fundamental understanding of risk-based C&Q prior to attending this course.
We recommend participants complete the primer course webinar that provides the background for the origins of the ICH guidelines, Q8(R2), Q9, Q10, and the basic concepts of risk-based commissioning and qualification to provide a foundation to the QRM process.
This course includes the primer webinar. Access information will be provided via email one week prior to the start of the training event.
This training course is of particular interest to existing and future members of the Commissioning and Qualification ISPE Communities of Practice.