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Course description

Key Topics Covered:

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Learning Outcomes

Quality Risk Management is now at the cutting edge of the life sciences industry internationally. ICH Q9 Guideline on Quality Risk Management (QRM) was incorporated in ICH Q10 GMP by the US FDA, MHRA, PIC/S, WHO and the EMEA.

Regulators expect that Quality Risk Management (QRM) is inherently built into the backbone of the Quality Management System (QMS). Pharmaceutical professionals should be able to use risk management techniques and tools based on ICHQ9 to manage product quality, manufacturing processes, validation and compliance within a risk based Quality Management System.

This highly interactive course consists of a lively mix of presentations, group exercises and discussions to provide an in-depth understanding of Quality Risk Management and know-how to be able to implement Quality Risk Management in the work place.

• Introduction to Quality Risk Management
• Why Risk Management
• Regulatory Perspective
• Major regulations and guidelines to Consider
• Understanding the different perspectives of risk management as they relate toPharmaceutical, Biopharmaceutical, medical devices and Food

Review the requirements of FDA, EMA, WHO and other guidance document on risk management
Implementing Quality Risk Management in Your Organization. The importance of the right culture and people
Role of leadership in risk management

• The Process Frame
• Starting the Quality Risk Management Process
• Introduction of the tools of risk management
• Introduction of the tools of risk management (Cont.)
• Challenges with Implementing Quality Risk Management

The course is designed to service a wide range of participants from various disciplines within the pharmaceutical and medical device industry. Typically, participants will be managers or supervisors who have experiences in a GMP related environment and need QRM to perform in their current position.
• Quality
• Production
• R&D
• Validation
• Engineering
• Risk
• Operations
• Manufacturing
• Project

• General principles and approach to risk management
• Regulatory requirements for application of risk principles
• Key steps and activities for a risk management program
• How compliance and risk management are strategically used
• Principles and requirements of ICH Q9
• How to classify cGMP non-conformances according to risk priority
• Application of risk analysis tools in production and process control
• How to apply risk management principles in process design

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Section 1
Final Quiz