PDA 530 Quality Risk Management: Risk Control and Risk-Based Decision-Making
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Individual Registration
Group Registration
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.
PDA Quality Risk Management Training Courses
PDA Regulatory Training Courses
- 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
Event Location
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Standard Pricing
Standard 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 [email protected].
Day 1
Training courses generally run from 8:30 to 16:00 each day unless noted on the agenda. Breakfast and lunch will be provided.
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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.
Renaissance Washington, DC Downtown
999 9th Street, NWWashington, DC , USA
Rate: $331 USD for single/double occupancy, plus state and local taxes
Cut-Off Date: Friday, 18 August 2023 (after this date the discounted PDA rate is no longer guaranteed)
Check-In: 15:00
Check-Out: 12:00
Reservations
Phone: +1 (800) 228-9290, make sure to refer to group code PDAN for the discounted conference rate
Online: Click on the reservation link above
Individual Cancellation
All cancellations must be received by 23:59 local time 72-hours before arrival to avoid a penalty of one night room and tax. Obtaining and canceling hotel reservations is the responsibility of the meeting participant. Individuals will be responsible for payment of their own cancellation fees.
Embrace the excitement of one of the world's most remarkable urban hubs at Renaissance Washington, DC Downtown Hotel. From museums to entertainment, this is the perfect base for exploring downtown DC. Additional perks for your hotel stay include a fully equipped, 24-hour fitness center. And at days end, relax in spacious hotel rooms with plush bedding, downtown views, Aveda bath products and Wi-Fi. Steps from shopping, dining, nightlife and sports, this hotel places the best of DC at your doorstep. Expect the extraordinary at Renaissance Washington, DC Downtown Hotel.