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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
Online
  • Virtual
  • Education
  • Online
Register Now

Overview

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

Agenda

  • 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)

Trainers

Tiffany A. Baker
Tiffany A. Baker
ValSource Inc.
Bio
Tiffany A. Baker
ValSource Inc.
Tiffany Baker is a quality risk management and microbiology consultant with ValSource, LLC. She specializes in development and implementation of innovative approaches to quality risk management (QRM), QRM program design, facilitating risk assessments, creating a risk-focused culture, and developing risk-based approaches to support contamination control strategies. Tiff is an active member of the Parenteral Drug Association (PDA), a faculty member for PDA’s Training Research Institute, and an instructor for the PDA courses on quality risk management foundations as well as practical application of QRM tools. She is also co-lead for the PDA task force on Remote Audits and Inspections. Additionally, she was a member of the core team who co-authored the ISPE Baseline guide 5 - Commissioning and Qualification, incorporating QRM into the process. She has a BS in microbiology from the University of Rhode Island and an MBA from Providence College.
Lori Richter
Lori Richter
Ultragenyx Pharmaceutical
Bio
Lori Richter
Ultragenyx Pharmaceutical
Lori Richter is the Director of GxP Global Learning and Risk Management at Ultragenyx. She holds a B.S. in Microbiology and over 21 years of experience working in the Pharmaceutical industry. Her areas of expertise include Quality Risk Management, Quality Systems and Business Continuity Management. She is a member of PDA and the Regulatory and Quality Advisory Board (RAQAB). She is also a co-host of the monthly podcast, Risk Revolution featured on Voices in Validation. She is pursuing her PhD through Technological University Dublin.

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.

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

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

Registration Fees

Register Now
Registration Type Price
All Participants $599

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