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
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