Problem Solving using DMAIC

Why Should You Attend:

Documenting CAPA investigations, the results and a convincing argument that the problem has been found and corrected can be a daunting process, as is evidenced by numerous FDA 483 observations related to CAPAs.

The DMAIC process encourages a logical approach to investigations that will facilitate determining root cause and will ensure a thorough well documented investigation. The DMAIC process can also be used beyond CAPA into any are where an investigation or analyzing to root cause is essential.

Areas Covered in the Webinar:

• Applying DMAIC as a problem solving methodology
• Collecting the right data
• Performing the analysis
• Asking the right questions
• Making fact based decisions
• Process Improvements through DMAIC
• Analysis tools - Fishbone diagrams

Who Will Benefit:

The following professionals from medical device start-ups and small to medium size device companies will benefit from this training:

• CAPA Owners
• CAPA Coordinators
• Troubleshooters
• Systems Engineers
• Test Engineers
• QA/QC
• Documentation
• Manufacturing Engineers
• Auditors

Instructor Profile:

Mercedes Massana, is the founder and CEO of MDM Engineering Consultants, a consulting firm that provides engineering and quality consulting services in the medical device, biotechnology, and pharmaceutical industries. Mercedes has over twenty-five years of experience in the Medical Device industry.  Extensive experience in developing processes within the constraints of FDA/lSO Quality Systems. She has been responsible for establishing processes and leading groups of engineering in the following disciplines: Risk Management, Requirements Management, Verification and Validation, Process Improvements, Project Management, Software Systems Validation, Process Validation. Mercedes is an ASQ certified Biomedical Auditor (CBA), Software Quality Engineer (CSQE), Quality Manager (CQMa) and Quality Auditor (CQA). Mercedes is well versed in FDA and ISO regulations.

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