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Home » Equip Val: How to Perform a Failure Mode Effect Analysis (FMEA) - Part 2

Equip Val: How to Perform a Failure Mode Effect Analysis (FMEA) - Part 2 (ELM-129)

Certification Training
Method of Training: Online / Self-paced eLearning.
Credits: 0.1 CPD Credits.
Duration: ~45 minutes.
Self-paced Training: 24/7 access to course.
Enrollment Period: 3 months.
CPD Accredited TrainingCatalog: Validation for BioPharma Companies.
Demonstration: Try one of our FREE courses.
Certificate: View sample certificate.

PRICE: USD $199.00

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Biopharma Institute LogoTraining Program: Equip Val: How to Perform a Failure Mode Effect Analysis (FMEA) - Part 2
Training Provided By: Biopharma Institute

Schedule: Self-paced. Immediate access to training materials upon ordering.

Description: Online training with immediate access upon enrollment. Biopharma Institute ReviewsQuality 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
Certification Requirements: Students must view the entire program and successfully pass an online, multiple-choice final assessment with passing score within a 90-day period of time (180 days for Professional Certification Programs). Certificate is accessible in PDF format immediately after satisfying requirements.

Equip Val: How to Perform a Failure Mode Effect Analysis (FMEA) - Part 2 course is included in the following Professional Certification Programs:

Equipment Qualification for Professionals: Review the individual courses included in this program (see below) for program descriptions and outlines. This online training program includes immediate access after enrollment. Username, password, and instru ... Learn more


Learning objectives
Who should take this course?
Course modules

FMEA - A General Overview
The advantages of a FMEA
So what is a FMEA?
Endorsed by the FDA
How did FMEA start?
ICH Q9: Quality Risk Management
Application of FMEA in the pharmaceutical industry
What can FMEA do for you?
When to conduct FMEA?

Getting Started with FMEA
The FMEA process
Risk identification
Risk analysis
Risk analysis - Probability of Occurrence (O)
Risk analysis - Severity (S)
Risk analysis - Likelihood of Detection (D)
Risk evaluation - Quantitative Method
Risk evaluation - Qualitative Method
The hybrid method
Risk - Should we quantify or qualify?
Risk control
FMEA - Table format
FMEA - Granulation suite qualitative approach example
Example of a risk assessment management plan
Example of a FMEA table for a granulation suite - Quantitative approach

Who Carries Out a FMEA?
The FMEA team
Qualification of the team members

Limitations of FMEA
What are the limitations of a FMEA process?
Subjective and tedious
Single failure mode
Rank reversal
Outputs and inputs
Limited scope
Only an assessment tool
Time consuming
Only as good as the team
Examination of external influences
Examination of human error
Reasons for ineffective FMEAs
Tips for successful implementation of a FMEA
Primary FMEA facilitation skills


Final Assessment



Skill Level:

This training program has been developed to train employees with Intermediate Knowledge of Equipment Qualification.

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