Module 3 - Quality Risk Management

1. Quality risk management

1.1 Quality risk managmement

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1.2 About this module

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1.3 Objectives

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1.4 Quality risk management

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1.5 Value creation and protection

1.6 Resources

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1.7 Methodologies

1.8 Application of QRM

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1.9 Application of QRM (continued)

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1.10 Think Big Picture

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1.11 Quick quiz 1

(Multiple Choice, 10 points, 1 attempt permitted)

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Correct Choice

X Critical Quality Attribute

Controlling Quality Automatically

Careful Questions for Audit

Feedback when correct:

That's right! You selected the correct response.

Feedback when incorrect:

The correct answer is Critical Quality Attribute.

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Correct (Slide Layer)

Incorrect (Slide Layer)

1.12 Quick quiz 2

(True/False, 10 points, 1 attempt permitted)

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Correct Choice

X True

False

Feedback when correct:

That's right! You selected the correct response.

Feedback when incorrect:

The correct response is True. The evaluation of risk to quality should be based on scientific
knowledge and ultimately be linked to the protection of the patient.

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Correct (Slide Layer)

Incorrect (Slide Layer)

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1.13 Who is responsible?

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1.14 ICH QRM overview

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1.15 Risk Assessment

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1.16 Identifying the risks

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1.17 Analyse and Evaluate

1.18 Risk reduction

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1.19 Risk acceptance

1.20 Preparing and implementing risk treatment plans

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1.21 Acceptance of Risks

1.22 Risk Management Report

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1.23 Periodic monitoring and review

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1.24 Failure Mode Effects Analysis

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1.25 Failure Mode, Effects and Criticality Analysis

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1.26 Fault Tree Analysis

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1.27 Hazard Analysis and Critical Control Points

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1.28 Hazard Operability Analysis

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1.29 Preliminary Hazard Analysis

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1.30 Tool application

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1.31 Risk ranking and filtering

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1.32 Statistical tools

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1.33 Quick quiz 3

(Multiple Choice, 10 points, 1 attempt permitted)

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Correct Choice

X 'as low as reasonably practicable' (ALARP)

'alert local emergency response team' (ALERT)

'as low as reason mandates' (ALARM)

Feedback when correct:

That's right! You selected the correct response.

Feedback when incorrect:

The correct answer is 'As low as reasonably practicable' (ALARP).

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Correct (Slide Layer)

Incorrect (Slide Layer)

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1.34 Final assessment

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1.48 Acknowledgement

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1.49 Disclaimer

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