Quality Risk Management in Pharma. Industry

1. Module 3 - Quality Risk Management 1. Quality risk management 1.1 Quality risk managmement Notes: Published by Articulate® Storyline www.articulate.com

2. 1.2 About this module Notes: Published by Articulate® Storyline www.articulate.com

3. 1.3 Objectives Notes: Published by Articulate® Storyline www.articulate.com

4. 1.4 Quality risk management 1.5 Value creation and protection Published by Articulate® Storyline www.articulate.com

5. 1.6 Resources 1.7 Methodologies Published by Articulate® Storyline www.articulate.com

6. 1.8 Application of QRM 1.9 Application of QRM (continued) Notes: Published by Articulate® Storyline www.articulate.com

7. 1.10 Think Big Picture Notes: 1.11 Quick quiz 1 (Multiple Choice, 10 points, 1 attempt permitted) Published by Articulate® Storyline www.articulate.com

8. 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. Published by Articulate® Storyline www.articulate.com

9. Correct (Slide Layer) Incorrect (Slide Layer) Published by Articulate® Storyline www.articulate.com

10. 1.12 Quick quiz 2 (True/False, 10 points, 1 attempt permitted) 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. Published by Articulate® Storyline www.articulate.com

11. Correct (Slide Layer) Incorrect (Slide Layer) Published by Articulate® Storyline www.articulate.com

12. 1.13 Who is responsible? Notes: Published by Articulate® Storyline www.articulate.com

13. 1.14 ICH QRM overview 1.15 Risk Assessment Notes: Published by Articulate® Storyline www.articulate.com

14. 1.16 Identifying the risks 1.17 Analyse and Evaluate Published by Articulate® Storyline www.articulate.com

15. 1.18 Risk reduction 1.19 Risk acceptance Published by Articulate® Storyline www.articulate.com

16. 1.20 Preparing and implementing risk treatment plans 1.21 Acceptance of Risks Published by Articulate® Storyline www.articulate.com

17. 1.22 Risk Management Report 1.23 Periodic monitoring and review Notes: Published by Articulate® Storyline www.articulate.com

18. 1.24 Failure Mode Effects Analysis Notes: Published by Articulate® Storyline www.articulate.com

19. 1.25 Failure Mode, Effects and Criticality Analysis Notes: Published by Articulate® Storyline www.articulate.com

20. 1.26 Fault Tree Analysis Notes: Published by Articulate® Storyline www.articulate.com

21. 1.27 Hazard Analysis and Critical Control Points Notes: Published by Articulate® Storyline www.articulate.com

22. 1.28 Hazard Operability Analysis Notes: Published by Articulate® Storyline www.articulate.com

23. 1.29 Preliminary Hazard Analysis Notes: Published by Articulate® Storyline www.articulate.com

24. 1.30 Tool application Notes: Published by Articulate® Storyline www.articulate.com

25. 1.31 Risk ranking and filtering Notes: Published by Articulate® Storyline www.articulate.com

26. 1.32 Statistical tools Notes: 1.33 Quick quiz 3 (Multiple Choice, 10 points, 1 attempt permitted) Published by Articulate® Storyline www.articulate.com

27. 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). Published by Articulate® Storyline www.articulate.com

28. Correct (Slide Layer) Incorrect (Slide Layer) Published by Articulate® Storyline www.articulate.com

29. 1.34 Final assessment Notes: Published by Articulate® Storyline www.articulate.com