QRM Decision Maker

Bethesda, MD
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Required courses:  2 courses
Duration: 3 days
Time: 8:30 a.m. - 4:00 p.m.

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.

Important Note

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.

Event Location
PDA Training and Research Institute
4350 East West Highway, Suite 150, Bethesda, MD Get Directions

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Day 1

Course 1 Title: Foundations of Quality Risk Management

Upon completion of this course, you will be able to:

  • Describe the Quality Risk Management (QRM) process and explain the roles and responsibilities
  • Describe when, where and how to apply risk management throughout the product lifecycle
  • Plan and prepare for quality risk management activities
  • Describe the formality associated with QRM tools
  • Describe the purpose of a risk register
  • Build a QRM program at your company

Course 2 Title: Quality Risk Management: Risk Control and Risk-Based Decision-Making

Upon completion of this course, you will be able to:

  • Explain the roles and responsibilities of decision makers in the QRM process
  • Assess the elements of risk-based decision making
  • Apply risk-based decision principles as part of QRM activities
  • Use risk assessment outcomes and risk register to define the most appropriate risk mitigation strategy
  • Differentiate between the types of risk control mechanisms and how to apply them
  • Examine how level of risk tolerance in an organization can impact risk control priorities and ultimately the effectiveness of QRM
Agenda is subject to change.

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PDA Training and Research Institute

4350 East West Highway, Suite 150
Bethesda, MD , United States

Course 1 Faculty

Lori Richter, Senior Consultant, Valsource, LLC

Lori Richter is a Senior Consultant at ValSource. She holds a Microbiology degree and over 18 years of experience working in the Pharmaceutical industry. Her areas of expertise include Quality Risk Management, Quality Systems, business continuity management, biotechnology manufacturing processes, and business process development. Her most recent role included developing an Integrated Risk Management program focused on strategic risk and business continuity management. Prior to that she held a global team role, developing and deploying a Quality Risk Management (QRM) program across the Roche Pharmaceutical Division, including developing tools, templates, and training materials, and integrating QRM into Quality Systems. She is currently a team member of the Parenteral Drug Association (PDA) Task Force, “Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems”, authoring TR 54-5.

Amanda B. McFarland, Senior Consultant, Valsource, LLC

Amanda Bishop McFarland, M.S. is a Quality Risk Management and Microbiology Consultant with Valsource, LLC with over 15 years industry experience. She specializes in the creation and implementation of Risk Management programs and in developing risk-based strategies for use in Microbiology. She has a Bachelors of Science (Entomology) and a Masters of Science in Mycology both from the University of Florida. Amanda is an active member of the Parenteral Drug Association (PDA); a faculty member of the PDA’s Quality Risk Management training series and the Quality Risk Management Interest Group co-lead.

Course 2 Faculty

Amanda B. McFarland, Senior Consultant, Valsource, LLC
Please see biography above

Emma Ramnarine, Senior Director, Head, Global Analytical Science & Technology, Genentech/Roche

Emma Ramnarine is accountable for the strategic direction and leadership for analytical methods, technologies, and control systems for Roche’s commercial Biologics and Small Molecule products — includes establishing and maintaining up-to-date, compliant and harmonized analytical control systems, proactive lifecycle management, technology innovation, method transfers, stability program, raw materials and reference standards management.

Emma has over 17 years of experience in the pharmaceutical, biotechnology and medical device industry in Quality System Management including developing and leading Quality Risk Management (QRM) programs. She is a worldwide-recognized expert on QRM, providing QRM leadership, governance, guidance, and training to regulatory authorities and at industry forums. She led the Task Forces for PCMOSM Technical Report Series No. 54 on “Implementation of Quality Risk Management”. She also led PDA’s Task Force for Technical Report No. 68 on “Risk Based Approach for Prevention and Management of Drug Shortages”, and is a representative for PDA on the inter-association European Drug Shortages Team that was formed under EMA’s direction.

Emma currently co-leads PDA’s Post Approval Change Task Force; she is on the PDA Board of Directors, PDA’s Regulatory Affairs and Quality Advisory Board (RAQAB), leads PDA’s QRM Interest Group, and has led the development of several PDA Technical Reports.


H. Gregg Claycamp, PhD, Senior Biomedical Research Scientist, Risk Analysis and Decision Analysis, U.S. FDA

Dr. Claycamp is a Senior Biomedical Research Service (SBRS) appointee whose duties include Risk Analysis and Decision Analysis in the Office of New Animal Drugs (CVM). He joined the FDA in 2001 to work on human health risk assessment from drugs approved for use in food animals in addition to a variety of risk analysis and decision analysis for regulatory scientific review and compliance problems. Since 2001 he also served as Director of the Div. of Compliance Risk Management and Surveillance in the Center for Drug Evaluation and Research (CDER) Office of Compliance. Dr. Claycamp continues to work on a portfolio of risk problems, risk management systems, and decision analysis tools for various levels of drug review and post-marketing risk management. He frequently speaks at industry and scientific conferences and publishes on these topics; reviews for a variety of risk and regulatory science journals; and teaches FDA courses in Risk Analysis and Risk-Informed Decision Making. Dr. Claycamp also serves on international working groups who developed “quality risk management” as a systems-based approach integrating quality systems and risk management for drug manufacturing. He was the regulatory lead for the final, internationally-harmonized guideline, "ICH Q9: Quality Risk Management” (http://www.ich.org). Presently, he is part of the design and delivery of risk management training for the PIC/S organization, which now include ~50 regulatory agencies worldwide. Dr. Claycamp’s AB is in Human Biology from Stanford University; MS and PhD degrees are in Radiological Health Engineering from Northwestern University. Prior to joining FDA, Dr. Claycamp was a Professor at the University of Pittsburgh where he directed graduate training programs in Risk Assessment and Radiation Health while maintaining an active research career including 70+ publications. He previously served on faculties of Radiation Biophysics at the Univ. of Kansas and the Dept. of Radiology at the Univ. of Iowa.