This live eLearning training course will provide an overview of the Quality Risk Management (QRM) process with an emphasis on the principles in ICH Q9 and ICH Q10. A portion of the training course will be focused on how QRM can be integrated into the Pharmaceutical Quality System and the use of QRM principles throughout the product lifecycle.
This training course will further build on the conceptual lessons by teaching practical skills, covering a broad look at QRM tools, templates, facilitation tips, and managing teams and bias. Lastly, this training course will close out with evaluating the power of decision-making in using a risk register and a best practice approach for building a QRM program at your company.
Participants will also receive a free copy of PDA Technical Report No. 54: Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations.
This training course is a prerequisite for all of the QRM Certificate Program tracks.