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

Sep 13 - Sep 14, 2021
Bethesda, MD

  • Education
  • The Americas

Overview

Please note that this training course will take place in person. Please read our COVID-19 Facility Access Rules before registering for this training course.

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 will not be provided, but 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

    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.

PDA Training and Research Institute

4350 East West Highway, Suite 110
Bethesda, MD

How to Get Here

By Air

The Washington/Bethesda area is serviced by the following airports: Ronald Reagan National Airport (DCA), Washington Dulles International Airport (IAD), and Baltimore Washington International Thurgood Marshall Airport (BWI).

By Car

There is a parking garage located at the training course location. The fee is $12/day. Please do not leave your car in the parking garage past 6:00 p.m. as both the building and parking garage access doors are locked.

Other Options

Metro – Ride the Red Line of the Metro and depart at Bethesda station. It is a 5-minute walk from Bethesda station to the training course location.

Amtrak – Ride Amtrak and depart at Union Station. From Union Station, ride the Red Line of the Metro and depart at Bethesda station. It is a 5-minute walk from Bethesda station to the training course location.

Directions

Registration Fees

Early Registration
Registration Type Price By July 30, 2021
Member $1,799
Non-member $2,159
Gov't/Health Auth./Academic* $1,399
Regular Registration
Registration Type Price After July 30, 2021
Member $1,999
Non-member $2,399
Gov't/Health Auth./Academic* $1,399

* 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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Contact

Program Inquiries
Exhibition Inquiries
Training Course Inquiries

Tel: +1 (301) 656-5900
[email protected]

Tel: +49 (0) 30 43 655 08-10

Registration Customer Care

Tel: +1 (301) 656-5900 ext. 115
[email protected]

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