Contamination Prevention and Control – Quality Risk Management (QRM)

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Description:

In this course, we will define Quality Risk Management, followed by a discussion on the need for both a risk management team and a risk management plan. Next, we’ll turn our attention to the ICH Q9 QRM process in more detail. We will continue with a closer look the FDA’s focus on risk assessments and European Commission insights on QRM. Finally, we will complete this course by covering QRM tool selection and taking a detailed look at the FMEA risk assessment tool for contamination prevention.

Curriculum for this course:

Introduction

Overview	1 min 10 secs
Learning objectives	50 secs
Who should take this course	45 secs
Course modules	1 min 13 secs

Module 1: Introduction to Contamination Prevention

Overview	58 secs
Why the concern over contamination	1 min 10 secs
Vaccines	1 min 32 secs
Parenteral medicine	1 min 18 secs
Terms explained	45 secs

Module 2: Quality Risk Management

Overview	2 mins 20 secs
QRM defined	1 min 20 secs
QRM team for contamination prevention	55 secs
ICH Q9 Quality Risk Management – Part 1	1 min 40 secs
ICH Q9 Quality Risk Management – Part 2	1 min 20 secs
FDA focus on risk assessments	2 mins 30 secs
QRM European Commission Insight	1 min 10 secs
Quality risk management tool selection	2 mins 28 secs
FMEA – Contamination preventation	1 min 20 secs
FMEA example	2 min 20 secs