PDA 530 Quality Risk Management: Risk Control and Risk-Based Decision-Making

Washington, DC
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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:

  1. Explain the roles and responsibilities of decision makers in the QRM process
  2. Assess the elements of decision-making
  3. Apply risk-based decision principles as part of QRM activities
  4. Differentiate between the types of risk control mechanisms and how to apply them
  5. Examine how level of risk tolerance in an organization can impact risk control priorities and ultimately the effectiveness of QRM
  6. Discuss how bias and heuristics play a role in the decision-making process
  7. 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.

Early Registration

Register by 29 July 2024

Member Price

$1,799

GovernmentMember Only

$1,399

Health AuthorityMember Only

$1,399

AcademicMember Only

$1,399

Non-Member

$2,159

Standard Registration

Register after 29 July 2024

Member Price

$1,999

GovernmentMember Only

$1,399

Health AuthorityMember Only

$1,399

AcademicMember Only

$1,399

Non-Member

$2,399

See Qualifying Criteria for Member Types.

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].

Agenda is subject to change.

Featured Trainers

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.

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.

Discover the vibrant heart of the city at the new Westin Washington, DC Downtown—an energizing gathering place bursting with fresh ideas. Immerse yourself in the allure of iconic experiences, just steps away from the hotel in Washington, DC. From the National Mall to Chinatown, Capital One Arena to the CityCenterDC outdoor shopping area, the best of the city awaits outside the doors. Unwind in inviting guest rooms, featuring the renowned Heavenly® Bed. Ignite your passion in the expansive 10,000 sq. ft. fitness center, the largest in Washington, D.C. Indulge in locally sourced culinary delights that will invigorate your senses. The hotel’s complete transformation has given rise to inspiring spaces, where Westin guests thrive, finding productivity and rejuvenation in perfect harmony.

Additional Hotel Information

  • Rate: $331 plus applicable taxes and fees (currently 15.95%)
  • Cut-Off Date: Friday, 09 August 2024
How to Get Here
By Air The Westin Washington, DC Downtown is accessible from three major airports: Ronald Reagan Washington National Airport (DCA - approx. 5 miles/8 km), the Washington Dulles International Airport (IAD - approx. 28 miles/45 km), and the Baltimore/Washington International Thurgood Marshall Airport (BWI - approx. 34 miles/55 km).
By Car The Westin Washington, DC Downtown is located at 999 9th Street NW, Washington, DC 20001. Both onsite parking ($48+/day) and valet parking ($65+/day) are available.
By Other Options The Westin Washington, DC Downtown is easily accessible from the following Metro stops: Gallery Place-Chinatown (Green, Red, and Yellow Lines, 7th St. & H St., NW exit - approx. 0.2 miles/0.3 km) and Metro Center (Blue, Orange, Red, and Silver Lines, 11th St. and G St., NW exit - approx. 0.4 miles/0.6 km).