Corrective And Preventive Action (CAPA) - Root Cause Analysis, Problem Solving

Duration: 60 Minutes
This webinar will present CAPA regulatory requirements and effective problem solving methods for device, manufacturing and quality system problems.
Root Cause Analysis
Instructor: Russell Pizzuto
Product ID: 500461

This FDA and MDD require "Corrective and Preventive Action" [CAPA]. More importantly, effective CAPA / problem solving are essential to delivering high quality medical devices and the health of your business. Guessing at root cause and problem solution effectiveness is equal to dissatisfied users, adverse events and regulatory problems.

This webinar will provide an understanding of CAPA regulations, root cause analysis and problem solving methods that can be applied to design, manufacturing and quality system problems. These methods deliver after compliant medical devices.

Why Should you Attend:
  • CAPA is essential to safe and effect medical devices
  • CAPA is frequently audited
  • Ineffective problem solving is equal to process inefficiency, customer dissatisfaction and adverse
Objectives of the Presentation:
  • Regulatory requirements and FDA expectations
  • Common mistakes and the importance of root cause analysis
  • The CAPA process
  • Device, manufacturing and quality system problems
  • Problem Solving Methods that identify Root Cause
  • Closing the Loop, measure the effectiveness of Problem Solutions
Who can Benefit:
  • Project managers
  • Quality managers and staff
  • R & D, Product Development and Sustaining Engineering, managers and staff
  • Regulatory and Compliance managers and staff
  • Compliance and Product Development Consultants
  • Anyone with Product Development, Risk Management, Regulator or Quality Assurance responsibilities
Live Session - How it works
  • Username and Password will be sent to you 24 hours prior to the webinar
  • Presentation handouts in pdf formate will be mailed to you
  • Login to the session using the username and password provided to you
  • Get answer to your queries through interactive Q&A sessions via chat
  • Please let us know your thoughts and views at the end of webinar, your valuable feedback will help us improve
  • Get certification of attendance.
Recorded Session - How it works
  • A link will be provided to you upon purchase of the recorded session
  • Please click on the link to access the session
  • Presentation handouts in pdf formate will be mailed to you
  • Get certification of attendance.
$375
Recorded Session for one participant
Get life time access with download option!
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Minimum 10 attendees
How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Russell Pizzuto has 40 year of experience in engineering and management with 12 years in medical device design, manufacturing and regulatory compliance. As a Design Engineering, Project Engineer and Director of New Product Development he has developed hundreds of new consumer and industrial products for fortune 500 companies. As Global Director of Engineering for a major medical products manufacturer with teams in USA, Europe, China and Mexico he delivered Class I and Class II medical device projects.

For the last two years he has served as President of PPRE Consulting, specializing in Product, Project and Regulatory Engineering. He holds a Medical Device certificate from the Regulatory Affairs Professionals Society (RAPS), has work on the FDA’s Hospital Bed Safety Work Group and served as an expert witness in Hospital Bed Safety litigation. Mr. Pizzuto has most recently focused on helping clients under FDA legal action, to bring their Design Control and Risk Management Systems into compliance.
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