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PDA 547.1 Technical Report No. 54-5: Quality Risk Management for the Design, Qualification, and Operation of Manufacturing Systems

Dec 01 - Dec 02, 2021
1:30 PM
-
4:30 PM
| Eastern Standard Time
Online
  • Virtual
  • Education
  • Online

Overview

This live eLearning training course will provide guidance and practical knowledge on how to manage quality risks throughout the manufacturing system lifecycle, as described in PDA Technical Report No. 54-5: Quality Risk Management for the Design, Qualification and Operation of Manufacturing Systems. Through a combination of lecture, workshops, and case studies, attendees will learn and apply a variety of tools and techniques to ensure appropriate management of quality risks for facilities, utilities, equipment, and other manufacturing systems.

Participants will also receive a free copy of PDA Technical Report No. 54-5: Quality Risk Management for the Design, Qualification and Operation of Manufacturing Systems.

PREREQUISITES

Participants enrolling in this training course must have completed the following PDA training courses:

  • PDA 529/529.1 Technical Report No. 54: Foundations of Quality Risk Management or any offerings of the prior PDA training course, Implementing Quality Risk Management for Pharmaceutical and Biotechnology Manufacturing Operations
  • Technical Report No. 54-2 and 54-4: Practical Application of Quality Risk Assessment Tools

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

Trainers

Tiffany A. Baker
Tiffany A. Baker
ValSource Inc.

Learning Objectives

  1. Explain how Quality Risk Management is applied in the lifecycle of manufacturing systems
  2. Apply Quality Risk Management principles and tools during the Design phase of a Manufacturing System
  3. Apply Quality Risk Management principles and tools during the Qualification phase of a Manufacturing System
  4. Apply Quality Risk Management principles and tools during the Operation, Maintenance and Retirement phases of a Manufacturing System lifecycle

Who Should Attend

This training course is intended for professionals who are responsible for quality risk management in manufacturing.

Departments
  • Quality Control
  • Quality Systems
  • Engineering
  • Manufacturing
  • Quality Assurance Operations
  • Regulatory Affairs
  • Validation

Roles
  • Analyst
  • Specialist
  • Supervisor
  • Manager

Registration Fees

Register Now
Registration Type Price
All Participants $399

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