PDA 530 Quality Risk Management: Risk Control and Risk-Based Decision-Making
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Individual Registration
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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.
This training course will provide you with the ability to interpret the appropriateness and adequacy of risk control mechanisms. You 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. This training 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
This training course is part of PDA's QRM Decision Maker Track. Participants enrolling in this training course must have completed one of the following PDA training courses:
- PDA 529/529.1 Technical Report No. 54: Foundations of Quality Risk Management
- Any offerings of the prior PDA training course, Implementing Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations
Additionally, participants should have read PDA Technical Report No. 54: Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations.
Upon completion of this training course, the attendee will be able to:
- Explain the roles and responsibilities of decision makers in the QRM process
- Assess the elements of decision-making
- Apply risk-based decision principles as part of QRM activities
- 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
- Discuss how bias and heuristics play a role in the decision-making process
- Understand "framing" of the decisions and explain how it impacts the outcome of your assessment
For more options and/or related training courses, please visit the page(s) below.
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Standard Registration
Member Price
$1,999GovernmentMember Only
$1,399
Health AuthorityMember Only
$1,399
AcademicMember Only
$1,399
Non-Member
$2,399
GROUP REGISTRATION DISCOUNT: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.
GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.
CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to registration@pda.org.
Featured Trainers
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Gregg H. Claycamp, MS, PhD
Read Bio
Gregg H. Claycamp, MS, PhD
Dr. Claycamp is an expert in risk management and decision making who recently retired from the Senior Biomedical Research Service (SBRS) at the FDA. He spent nearly twenty years at the FDA working on human health risk analysis related to both human and food animal drugs. Dr. Claycamp joined FDA-wide groups on the 21st Century GMP Initiatives 2002 and shortly after proposed risk ranking and filtering methods for risk-prioritizing GMP surveillance inspections. In 2007, he joined CDER’s Office of Compliance and subsequently served as Director of the Div. of Compliance Risk Management and Surveillance. Dr. Claycamp worked 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 made frequent research and training presentations at industry and scientific conferences and publishes on these topics; reviews for a variety of risk and regulatory science journals; and leads courses in Risk Analysis and Risk-Informed Decision Making. Dr. Claycamp also served 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. During the recent past, Dr. Claycamp participated in the design and delivery of risk management training for the FDA, PDA, and the PIC/S organization.
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 the 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 ~80 publications. He previously served on faculties of Radiation Biophysics at the Univ. of Kansas and the Dept. of Radiology at the Univ. of Iowa.
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Request InformationPLEASE 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.
Westin Washington, DC Downtown
999 9th Street, NWWashington, DC 20001, United States
Individual reservations cancelled within seventy-two (72) hours prior to arrival will forfeit one night’s room deposit. Individuals will be responsible for payment of their own cancellation fees.
Additional Hotel Information
- Rate: $331 plus applicable taxes and fees (currently 15.95%)
- Cut-Off Date: Friday, 09 August 2024