Course 1 Title: Foundations of Quality Risk Management
This 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 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. The 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 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.
This course is an updated version of a prior PDA course, “Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operation.” Please note that the content of both courses is similar. If you have already taken “Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operation,” we recommend that you consider taking “Foundations of Quality Risk Management” only as a refresher.
Course 2 Title: Quality Risk Management: Risk Control and Risk-Based Decision-Making
To control risk, decisions must be made as part of the quality risk management (QRM) process. Risk-based decision-making tends to be more dynamic and less structured than the other steps of the QRM process. A decision-maker’s role in the QRM process is critical for timely, effective and ongoing management of risks. The course will provide participants with the ability to interpret the appropriateness and adequacy of risk control mechanisms. Attendees will also explore the overall concepts of risk-based decision-making including risk tolerance, its impact on the success of risk management, and how to manage diversity in risk tolerance across your organization. The course will strengthen learners’ competencies to identify and assess the results of a QRM exercise in order to enable robust risk-based decisions and enable success of QRM activities.
Prerequisites: Participants enrolling in this course must have completed one of the following PDA courses:
- “Foundations of Quality Risk Management” taking place Monday, December 11, 2017 at the PDA Training and Research Institute in Bethesda, Maryland.
- Any offerings of the prior PDA course, “Implementing Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations.”
Additionally, participants should have read PDA Technical Report 54 (TR 54), Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations.
Who Should Attend
The QRM Decision Maker track includes two courses: “Foundations of Quality Risk Management” and “Quality Risk Management: Risk Control and Risk-Based Decision-Making.” This training module is applicable to supervisors, managers and directors from disciplines such as quality assurance, quality control, engineering, validation, production and technical services, who often make decisions based on the outcomes of risk assessments for their areas of responsibility.