Quality Risk Management In Pharmaceuticals

Quality Risk Management in Pharmaceuticals

What you'll learn
Performing quality risk management
Practical implementation of QRM
Updates in quality risk management
This course is self made for personal upgradation in pharmaceuticals

Requirements
The person should be full focussed during the session.

Description
The training lecture will help you to learn a brief introduction of the topic and scope Brief on ICH Quality Guidelines and Understanding guidelines for Quality Risk Management Updates in the new version of the guideline ICH Q9 (R1) Understanding of – Managing your risk has its own rewards. Role of ICH Q9 with ICH Q8 and ICH Q10 Practical understanding of Quality Risk Management (QRM) process and how to perform QRM by failure mode effect analysis tool. Action Priority Tablet concept/Heat map matrix Vote of Thanks - Q&A session.Further, there is a small video lecture that will help you to understand Quality Risk Management principles, how it is simple and easy to implement and achieve the compliance level. We have explained this with simple examples.The last lecture video will help you to learn further about Good Review practices. This training will include, some examples of Food and Drugs Administration (FDA) citations, regulatory expectations about the review, 10 key principles about good review practices, how to qualify reviewers, and many more. Overall this training session will take you through an understanding of quality risk management, what is updated in the revised ICH Q9(R1) guideline, with practical examples and good review practices based on risk-based approach.

Overview
Section 1: Introduction

Lecture 1 Introduction

Lecture 2 Quality Risk Management ICHQ9(R1) Part-1

Lecture 3 Quality Risk Management ICHQ9(R1) Part-2

Lecture 4 Quality Risk Management ICH Q9(R1) Part -3

Lecture 5 Good Review Practices - A Risk Based Approach

Professionals of pharmaceutical industry, Quality Assurance, Quality control (Analytical laboratory), production, engineering, R&D, development, investigation team, compliance team etc.

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