ComplianceOnline

Problem Solving using DMAIC

Instructor: Mercedes Massana
Product ID: 704807
Training Level: Intermediate
  • Duration: 60 Min
Purchase option for this webinar is currently unavailable. Please contact our Customer Care for more info.

Customer Care

Fax: +1-650-565-8542

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This webinar will provide an introduction into the DMAIC problem solving process and will show how DMAIC can be utilized to ensure that any process which requires an investigation to be performed can be thoroughly addressed and well documented.

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.

Follow us :
eCTD Submissions of IND and NDA/BLA to the US FDA, EU and Canada
Computer System Validation - Reduce Costs and Avoid 483s

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. ComplianceOnline 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.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

Product Reviews

This product hasn't received any reviews yet. Be the first to review this product! Write review

Best Sellers
You Recently Viewed
    Loading