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PDA 530.1 Quality Risk Management: Risk Control and Risk-Based Decision-Making

Sep 16, 2022
Washington, DC

  • Education
  • The Americas

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Overview

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.

For more options and/or related training courses, please visit the page(s) below.

PDA Quality Risk Management Training Courses

Agenda

  • Training courses generally run from 8:30 to 16:00 each day. Breakfast and lunch will be provided.

Trainers

Gregg H. Claycamp
Gregg H. Claycamp
Food and Drug Administration

Additional Information

  • Learning Objectives

    Learning Objectives

    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
  • Who Should Attend

    This training course is intended for professionals who make decisions based on the outcomes of risk assessments.

    Departments
    Quality Control, Engineering, Manufacturing, Quality Assurance Operations, Validation, Facilities

    Roles
    Supervisor, Manager, Director

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Travel

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.

Renaissance Washington, DC Downtown Hotel

999 9th Street NW
Washington, DC

Make a Reservation
  • Accommodations

    Book within the PDA block and be automatically entered to win a daily treat delivered to your hotel room!

    A block of rooms have been reserved for meeting participants at the Renaissance Washington, DC Downtown Hotel. The rate is $322 for single or double occupancy. Guestroom rates are subject to State and Local taxes. Reservations must be secured by Monday, 15 August 2022. After this date, reservations can be made on a space-and-rate available basis only. Check-in time is 3:00 p.m.; check-out time is 12:00 p.m.

    To make reservations, individuals may click on the reservation link above or call the Renaissance at +1 (202) 898-9000. Be sure to tell the reservationist that you are with the PDA Meeting to receive the PDA group rate.

    Individual Cancellation

    Please be aware that obtaining and canceling hotel reservations is the responsibility of the meeting registrant. Individuals will be responsible for payment of their own cancellation fees. The cancellation policy is 3 days in advance of arrival unless otherwise specified on your reservation information.

  • Amenities

    Embrace the excitement of one of the world's most remarkable urban hubs at Renaissance Washington, DC Downtown Hotel. Set in the heart of the city, our upscale hotel is steps from Capital One Arena, Penn Quarter and the Walter E. Washington Convention Center. From museums to entertainment, this is the perfect base for exploring downtown D.C. Fuel up for a busy day downtown with breakfast weekdays at Mixx or weekends at Fifteen Squares Restaurant. Our Grand Ballroom, meeting rooms and 11th-Floor Terrace are also available for a host of multi-sensory events, from important conferences to joyful weddings. 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 and suites with beautiful terraces.

How to Get Here

By Air

Reagan National Airport (DCA) is approximately 5 miles from the hotel and all major carriers service this airport. Two other airports in the vicinity are both serviced by all major carriers: Dulles International Airport (IAD), 27.8 miles away, and Baltimore-Washington International Airport (BWI), 34 miles away. Taxi fares from DCA are approximately $25 one way, not including tip, and will take about 15 minutes. One way taxi fares from IAD is approximately $70 and from BWI about $85.

By Car

The Renaissance Washington, DC Downtown Hotel is located at 999 9th Street NW, Washington, DC. Parking is available onsite at the following rates: Daily Self Parking - $35 Daily Valet Parking - $60.18

Other Options

Gallery Place Metro Station is 0.5 miles away from the hotel and is approximately $2.50 one way to Reagan National. Union Station is 1 mile away from the hotel. To book your reservation, call Amtrak at 1 (800) 872-7245 or visit http://www.amtrak.com.

Directions

Registration Fees

Early Registration
Registration Type Price By August 2, 2022
Member $699
Non-member $699
Gov't/Health Auth./Academic* $699
Regular Registration
Registration Type Price After August 2, 2022
Member $999
Non-member $1,199
Gov't/Health Auth./Academic* $699

* For this member type or discount, online registration is not available, please contact [email protected].

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].

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