Course contents

  • Introduction to Risk (PHRM0103)

    A comprehensive overview of Risk Management, giving you the ability to understand key terminology and build your foundation knowledge

  • Introduction to Quality Risk Management (PHRM0203)

    Gain a comprehensive knowledge of QRM with concise and easily understandable materials.

    Explore the advantages of implementing formal risk assessment techniques in combination with collaboration among cross-functional teams while learning about senior management’s part in effective Risk Management implementation.

  • Risk Management Tools (PHRM0303)

    A fundamental exploration into Quality Risk management, introducing users to the foundational tools they need for successful facilitation.

    From flowcharts and Pareto charts to pie charts and FMEA - this introductory guide covers all of the essential tools required in risk management

  • Quality Risk Management - The Process (PHRM0503)

    become a professional in Quality Risk Management

    We'll take you through the necessary steps to implement and execute risk management successfully. Learn all about assessing risks, controlling them effectively, communicating processes clearly and monitoring progress regularly - vital components of QRM that cannot be overlooked

Learning outcomes

By the end of this module, GMP personnel should move from the fundamental concepts to the deeper understanding of Quality Risk Management.

Gaining knowledge of the requirements of ICH Q9 and its application to the pharmaceutical manufacturing environment.

  • Understand risk and the principles of Quality Risk Management (QRM)

  • Understand the importance of QRM throughout the product lifecycle

  • Understand how and when to initiate a risk management event and the appropriate QRM methodology

  • Identify and choose the right QRM tools for different stages of QRM events

Course Features

  • Modules

    Four modules

  • Duration

    3 hours total

  • Language

    English

  • Assessment

    Interactive self assessment

  • Skill level

    Entry level