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Quality Risk Management Overview

This document outlines the key concepts and processes involved in quality risk management for pharmaceutical manufacturing. It introduces risk management principles and regulations. It then describes how to establish a risk management program within an organization, including defining roles and responsibilities. Various risk assessment tools are presented, and the full risk management process is outlined, from risk identification to risk control and reporting. Finally, approaches for applying risk management across the entire product lifecycle from design to decommissioning are discussed.

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Paula Lwiz Isskander
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125 views2 pages

Quality Risk Management Overview

This document outlines the key concepts and processes involved in quality risk management for pharmaceutical manufacturing. It introduces risk management principles and regulations. It then describes how to establish a risk management program within an organization, including defining roles and responsibilities. Various risk assessment tools are presented, and the full risk management process is outlined, from risk identification to risk control and reporting. Finally, approaches for applying risk management across the entire product lifecycle from design to decommissioning are discussed.

Uploaded by

Paula Lwiz Isskander
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

Introduction to Risk Assessment

Outlines

Introduction to Quality Risk Management 
Introduction to Risk Management and Risk Assessment 
Principles of Quality Risk Management 
Regulatory Overview (ICH Q9) 
Identify why Risk Management has become important in the regulatory world of 
pharmaceutical manufacturing 

How Risk Management could work for your organization 
Determine the success criteria for utilizing Risk Management 
Risk Management teams, roles, strong leadership, documentation and likely 
pitfalls 

QRM Tools 
What tool is suitable and when 
Practice Risk Assessment 
Application of a risk decision tree 
Risk Management Plan Development and Implementation 
Risk Management Roles and Responsibilities Breakout 
Development of a Risk Management Plan Outline 
QRM Process 
Risk Identification 
Risk Analysis 
Risk Assessment 
Risk Evaluation 
Risk Control (Reduction and Acceptance) 
Ranking and Trending 
Reports and Outputs 
What Your Company Needs to Establish a Formal QRM Program

Scientific Activists for Consulting and Training Company
Queen Rania Street, Al‐Awamleh Complex, Build. 373, Amman, Jordan 
Mob: 00962791533337 / Tel: +962 ‐ 6 ‐537‐2725 Fax: +962 ‐ 6 ‐537‐2726 
Introduction to Risk Assessment
Outlines

 
Risk Management Plans (RMP) 
Risk and Issue Management Strategy 
Risk Identification Technique 
Risk Evaluation Technique 
 
QRM across the Product Lifecycle 
Implementation of QRM from Design to Decommissioning 
Process  Risk 
Product  Risk 
Market Risk 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Scientific Activists for Consulting and Training Company
Queen Rania Street, Al‐Awamleh Complex, Build. 373, Amman, Jordan 
Mob: 00962791533337 / Tel: +962 ‐ 6 ‐537‐2725 Fax: +962 ‐ 6 ‐537‐2726 

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