Failure Modes and Effects Analysis (FMEA) - An Effective Tool for Risk Management

This Failure Modes and Effects Analysis (FMEA) Webinar will give an overview and elements of an FMEA. The analysis of data outputs will also be discussed.

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Why Should You Attend:

Risk management should be part of the entire product life-cycle to ensure that finished devices and should include risk analysis, risk evaluation and risk control. Many tools and processes can be used for risk management, assessment, and control. Failure Modes and Effects Analysis (FMEA) is one of the suggested tools. The FMEA process identifies potential failure modes, the effects of the failure mode, the potential causes of the failure and controls (if any) that are in place to detect the failure. Risks are evaluated in terms of Severity, Occurrence and Detection providing a Risk Priority Number to asses the overall risk level and actions for risk abatement or elimination. This Webinar will give an overview and elements of an FMEA. The analysis of data outputs will also be discussed.

Areas Covered in the seminar:
  • Quality Systems Regulations and Risk Management
  • ISO 14971 overview
  • Failure Modes and Effects Analysis overview
  • Elements of an FMEA
  • Types of FMEAs
  • FMEA analysis techniques
  • Risk abatement and control
  • Change Control
Who Will Benefit:

This Webinar will provide an overview of risk management and detail the elements of Failure Modes and Effects Analysis (FMEA), the types of FMEAs and how to analyze data and outputs from an FMEA.

  • VPs of Marketing, Quality, Technology and Engineering
  • Quality managers and engineers
  • Manufacturing and production engineers
  • Design engineers
  • Product development teams
Instructor Profile:
Vinny Sastri Vinny Sastri

President, WINOVIA® LLC

Dr. Vinny Sastri, President of WINOVIA® LLC, and has over 20 years experience in new product development and quality improvement with a strong track record in the healthcare, medical device, electronics and consumer goods industries. He is a certified Six Sigma blackbelt. Winovia LLC a consulting company that provides sustainable solutions new product development, quality improvement and high performance materials with the goal of strategic market penetration, improving efficiencies of products, processes and services, streamlining business processes, reducing operational costs, improving margins and increasing revenues and profits for its clients.

Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

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