Contamination Prevention and Control – Quality Risk Management (QRM)

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
Conclusion
Final Assessment
Certification
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