PH00101 - Introduction to Quality Risk Management
Course Description:
In the pharmaceutical industry, products are expected to be "fit for purpose" and manufactured "right first time". GMP provides the framework to reduce the risks inherent in any pharmaceutical production process. It is important to identify and control these risks to ensure the safety and efficacy of drug products throughout the life cycle of a drug.
However, to carry out any Risk Management, it is important to understand the basics of Risk Management.
This course dives into the concept of Risk Management, first introducing fundamental concepts and then exploring in more detail Quality Risk Management (QRM). Develop a detailed understanding of ICH Q9 quickly with clear definitions and straightforward explanations. Receive step-by-step guidance on performing assessments to identify risks as well as strategies for managing them effectively.
Learning Outcome:
- Understand what risk is
- Explain the overall concept of Risk Management
- Explain what Quality Risk Management (QRM) is
- Understand the principles of QRM
- Understand the importance of QRM throughout a product life cycle
- Understand how and when to initiate a QRM
- Understand Quality Risk Management Methodology
- Identify the different classes of Risk Management tools
- Explain the importance of choosing the right tools for risk assessment
- Understand the process of selecting the right tools for Quality Risk Management
- Understand what risk is
- Explain the overall concept of Risk Management
- Explain what Quality Risk Management (QRM) is
- Understand the principles of QRM
- Understand the importance of QRM throughout a product life cycle
- Understand how and when to initiate a QRM
- Understand Quality Risk Management Methodology
- Identify the different classes of Risk Management tools
- Explain the importance of choosing the right tools for risk assessment
- Understand the process of selecting the right tools for Quality Risk Management
Course Features
| Modules | : | 4 |
| Duration | : | 3 Hour(s) |
| Language | : | English |
| Assessment | : | Self |
| Skill Level | : | Entry |
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Course Content(s)
Introduction to Risk (PHRM0102)
This module provides a comprehensive overview of Risk Management, giving you the ability to understand key terminology and build your foundation knowledge. Start down the path towards becoming an expert in this field!
Introduction to Quality Risk Management (PHRM0202)
This module dives into the concept of Quality Risk Management (QRM). It is designed to help you gain a comprehensive knowledge of QRM with concise and easily understandable materials. Through this training, you will 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 (PHRM0302)
This module offers 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 (PHRM0502)
With this module, you will 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!
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