Quality Risk Management Using Failure Modes, Effects and Criticality Analysis

Failure Modes, Effects and Criticality Analysis (FMEA) are a worthwhile method for identification and prioritization of potential failures of a product or process. With the advent of managed risk approaches for many business processes, the concept of risk management has taken on new emphasis as part of an FDA-regulated quality practitioner’s tool kit. Diane Kulisek of CAPAtrak LLC will provide an overview of FMECA as one of the fundamental risk assessment methodologies, explain how FMECA can support regulatory requirements for risk management and provide guidance on how to validate the effectiveness of FMECA outcomes through appropriate metrics. Diane will also provide internet links to valuable on-line FMECA and Risk Management references as well as to downloadable FMEA templates for use with MS Excel in association with this presentation.

Areas Covered in the seminar:

• Risk Management and FMECA Terminology.
• Quality Management System Considerations.
• What Standards and Regulations Require with regard to Risk Management.
• How FMECA relates to fulfillment of Risk Management Requirements.
• How and Where Risk Management is best addressed within the Quality Management System.
• The FMECA Process.
• Elements of an FMECA Template.
• Tips for Effective FMECA Efforts and How to Avoid FMECA Pitfalls.
• Risk Management and FMECA Links and Tools.

Who Will Benefit:

This webinar will provide valuable assistance to all FDA-regulated organizations seeking to implement Risk Management through effective FMECA efforts, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. Personnel who will benefit include:

• End-users responsible for assessing the effectiveness of Risk Management Programs
• QA/RA Directors and Engineers
• Design, Product Development and Process Development Managers, Scientists and Engineers
• Risk Management and FMECA Specialists
• Consultants
• Quality Management System Auditors

Instructor Profile:

Diane Kulisek, MSE is a senior quality assurance and regulatory compliance practitioner with over 20 years of practical experience in regulated industries. She is the founder of CAPAtrak LLC and general manager of the CAPAtrak subsidiaries, CertLean, QualityWarrior and TrackQuality. A frequently published author and popular public speaker, Diane holds a Graduate Certificate in Program Management and ASQ certifications as a Manager of Quality/Organizational Excellence and as a Quality Engineer. Diane is currently the Chair of the ASQ Food, Drug and Cosmetic Division.

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