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PDA 529.1 Technical Report No. 54: Foundations of Quality Risk Management

Jul 25 - Jul 26, 2023
9:00 AM
12:00 PM
| Eastern Standard Time
  • Virtual
  • Education
  • Online


This live eLearning 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.

Participants will also receive a free copy of PDA Technical Report No. 54: Implementation of Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations.

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


  • Day 1
  • Day 2
  • Introduction and Objectives (20 min)

    Section 1: What is Risk Management? (55 min)

    Break (15 min)

    Section 2: Applications of QRM (90 min)

  • Review and Reflection (20 min)

    Section 3: QRM Tools / Section 4: Risk Assessment Outputs: Now What? (55 min)

    Break (15 min)

    Section 5: Building a QRM Program at Your Company (60 min)

    Open Discussion (30 min)


Tiffany A. Baker
Tiffany A. Baker
ValSource Inc.
Lori Richter
Lori Richter
Ultragenyx Pharmaceutical

Learning Objectives

  1. Describe the 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

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

  • Quality Control
  • Quality Systems
  • Quality Compliance
  • Engineering
  • Manufacturing
  • Quality Assurance Operations
  • Validation

  • Analyst
  • Specialist
  • Operator/Technician
  • Supervisor
  • Manager

Registration Fees

Register Now
Registration Type Price
All Participants $599

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