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PDA 529 Technical Report No. 54: Foundations of Quality Risk Management

Sep 30, 2021
Washington, DC

  • Education
  • The Americas

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Overview

This training course will provide an overview of the Quality Risk Management (QRM) process with an emphasis on the principles in ICH Q9 and ICH Q10. A portion of the training course will be focused on how QRM can be integrated into the Pharmaceutical Quality System and the use of QRM principles throughout the product lifecycle.

This training course will further build on the conceptual lessons by teaching practical skills, covering a broad look at QRM tools, templates, facilitation tips, and managing teams and bias. Lastly, this training course will close out with evaluating the power of decision making in using a risk register and a best practice approach for building a QRM program at your company.

This training course is a prerequisite for all of the QRM Certificate Program tracks.

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

Tiffany Baker
Tiffany Baker
Concordia ValSource LLC
Amanda M. McFarland
Amanda M. McFarland
ValSource Inc.

Additional Information

  • Learning Objectives

    Learning Objectives

    1. Describe the Quality Risk Management (QRM) process and explain the roles and responsibilities
    2. Describe when, where and how to apply risk management throughout the product lifecycle
    3. Plan and prepare for quality risk management activities
    4. Describe the formality associated with QRM tools
    5. Build a QRM program at your company
  • Who Should Attend

    Who Should Attend

    This training course is intended for professionals who are new to quality risk management.

    Departments
    Quality Control, Quality Systems, Quality Compliance, Engineering, Manufacturing, Quality Assurance Operations, Validation

    Roles
    Analyst, Specialist, Operator/Technician, Supervisor, Manager

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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 Hotel

999 9th Street NW
Washington, DC

  • Accommodations

    The PDA room block is not currently open. Please check back June 2021.

  • Amenities

    More information coming soon.

How to Get Here

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Directions

Registration Fees

Early Registration
Registration Type Price By August 16, 2021
Member $899
Non-member $1,079
Gov't/Health Auth./Academic* $699

Regular Registration
Registration Type Price After August 16, 2021
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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Tel: +1 (301) 656-5900
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Tel: +49 (0) 30 43 655 08-10

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