How to Perform a Failure Mode Effect Analysis (FMEA) – Part 1
Description:
Quality Risk Management (QRM) principles require the evaluation of risk to patient safety and product quality based on scientific knowledge, data and experience. Regulators expect that QRM is inherently built into the backbone of the Quality Management System (QMS) by using a lifecycle approach to implement both formal and informal risk tools that support the elements defined in ICH Q9 for risk assessment, risk control, risk review, communication of identified Risks and acceptance of residual risks. Upon completion of this course you will understand the overall concept of Quality Risk Management (QRM), where does risk come from, the potential areas for Quality Risk Management application, the regulatory requirements and the various risk management tools.
Curriculum for this course:
Introduction
| Overview | 1 min 10 secs |
| Learning objectives | 1 min 41 secs |
| Who should take this course? | 1 min 18 secs |
| Course modules | 1 min 51 secs |
| Glossary | 1 min 54 secs |
Module 1: Introduction
| The advantages of a FMEA | 1 min 49 secs |
| Patient safety | 1 min 14 secs |
| Explaining risk | 1 min 10 secs |
| Where does risk come from? | 1 min 25 secs |
| Understanding Quality Risk Management (QRM) | 1 min 25 secs |
| Potential areas for quality risk management application | 1 min 33 secs |
Module 2: Quality Risk Management – Regulatory Requirements
| Pharmaceutical regulatory requirements | 1 min 30 secs |
| United States Food and Drug Administration (FDA) | 1 min 19 secs |
| 21 CFR Part 11 – Scope and application (2003) | 49 secs |
| European regulations | 50 secs |
| International Conference for Harmonization (ICH) | 1 min 19 secs |
| International Standards Organization (ISO) | 1 min 31 secs |
| ISO 14971:2007 – Application of risk management to medical devices | 1 min 46 secs |
| European regulations | 1 min 15 secs |
| International Conference for Harmonization | 1 min 30 secs |
Module 3: Risk Management Tools
| Widely used methods | 1 min 26 secs |
| Basic risk management methods | 1 min 13 secs |
| Failure Mode and Effects Analysis (FMEA) | 1 min 33 secs |
| Failure Mode Effects & Criticality Analysis (FMECA) | 1 min 49 secs |
| Fault Tree Analysis (FTA) | 1 min 19 secs |
| Hazard Analysis and Critical Control Points (HACCP) | 1 min 31 secs |
| Hazard Operability Analysis (HAZOP) | 2 min 39 secs |
| Preliminary Hazard Analysis (PHA) | 1 min 22 secs |
| Risk Ranking and Filtering | 1 min 58 secs |
| Supporting statistical tools | 1 min 04 secs |
| Quality risk management tool selection | 1 min 54 secs |
Conclusion
Final Assessment
Certification
Author:
General Info:
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CEU Credits: 0.1 -
Course code: ELM-128 -
Duration: 45 mins -
Skill Level: Intermediate -
Language: English -
Final Exam: Yes -
Certificate of Completion: Yes
Reviews:
Finally, a course that explains risk and FMEA in an easy way.
Really enjoyed this course and the practical examples used.
An invaluable resource to someone like me who is new to FMEA.
The risk management tools section is great, very well explained.
Related courses:
How to Perform a Failure Mode Effect Analysis (FMEA) – Part 2
Contamination Prevention and Control in a GMP Environment
Contamination Prevention and Control – Quality Risk Management (QRM)
Risk Based Equipment Qualification
21 CFR Part 820 Subpart C – Design Controls
21 CFR Part 820 Subpart D – Document Controls
21 CFR Part 820 Subpart F – Identification and Traceability
Good Laboratory Practices: History and Regulatory Compliance
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