Quality Risk Management Facilitator Training - New Course

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

Since ICH Q9 was first introduced, the industry has been working toward effective implementation and execution of Quality Risk Management. On the road to compliance, one of the barriers in the effective execution of risk management has been the lack of personnel to confidently lead and facilitate complex risk activities. Strong facilitator skills are instrumental when guiding teams through risk management activities. Organizations can thrive when their risk program is effectively, consistently and pragmatically practiced through the use of risk facilitators.

Risk Facilitators have the unique role of engaging multiple disciplines in the risk management process and with this role comes the opportunity to explore the vulnerabilities of an organization (i.e., the risky business). This course will guide individuals in navigating the risk management process as a Risk Facilitator. The attendees will gain perspective on the Risk Facilitator role, identify the key elements of developing and communicating a risk plan, and work with real-life case studies to demonstrate their ability to successfully lead a risk activity, overcome perception, improve personal insights and develop the ability to control biases and other obstacles along the way.

Prerequisites

IMPORTANT NOTE: Participants enrolling in this course must have completed two PDA courses:

If you are interested in registering for this course but have not completed the two courses as prerequisites above, you will be required to submit your CV and participate in a phone interview to demonstrate your competency in risk management principles and formal risk management tools (i.e., PHA, FMEA, HACCP). Please contact Stephanie Ko at [email protected] for more details.

Who Should Attend

Individuals who will benefit from this course have the task to facilitate or help teams through risk management activities, making sure that that the right tools are chosen and that the tools are used as intended to meet the desired outcome in an effective way.

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

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More information coming soon.

Day 1

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

  • Identify characteristics of a strong risk facilitator, ensuring that objectives are met effectively, consistently and pragmatically
  • Define the purpose of a risk facilitator
  • Recognize and overcome bias and heuristics (including the personal preferences and bias in the facilitator)
  • Define the objectives of a given risk management process and develop a risk management plan
  • Communicate the risk plan and the outcome of the risk management process to relevant stakeholders
  • Outline potential pitfalls and how to overcome them
Agenda is subject to change.

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

PDA Training and Research Institute

4350 East West Highway
Bethesda, MD , United States

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.