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  • Bulletproof CAPA Handling and Investigations for Medical
    Devices: 2 - Day In-person Seminar

  • Hosted By:
  • ComplianceOnline
  • Start:
  • Thursday - Nov 07, 2013 08:30 AM
  • End Time:
  • Friday - Nov 08, 2013 04:30 PM
  • Location:
  • Boston,
    Massachusetts, United States
  • Course Description:
    FDA's findings of Medical Device company Quality System Regulation (QSR) deficiencies in 2012 fall into four areas, of which two are especially prominent: Corrective and Preventive Action (CAPA) and Production and Process Controls (P&PC), both of which accounted for 30% of all cited deficiencies. Between January 2012 and May 2013, FDA issued 126 Medical Device Warning Letters containing noted CAPA deficiencies.

    The average cost of a Warning Letter remediation effort is estimated at US $750,000 in order to correct the FDA identified deficiencies including added resources for consultants, personnel, remediation of legacy records, etc. This cost estimate does not even include the ramifications of product recalls or holds, cost of not going to market with a new device, or delays in FDA 510(k) or PMA (Premarket approval) as a result of a Warning Letter.

    The cost of FDA non-compliance is therefore WAY more than the cost of compliance. Are you in compliance with the FDA CAPA regulations for medical devices?

    In this two day workshop conference you will learn how to use the FDA Quality System Inspection Technique (QSIT) and methods of problem solving in order to develop and implement bulletproof solutions that are accepted, effective, and efficient. Through case study analysis we will examine best practice CAPA Systems to provide thoughts and ideas to improve the performance of your current system. Additionally, case studies will explore how your CAPA management practices can help or hurt your legal liability and the legal issues that arise from nonconformance with regulators (FDA) and Auditors.

    Learning Objectives:
    Upon completing this course participants should:

    -Understand how FDA inspects CAPA to QSIT (Quality System Inspectional Technique)
    -Utilize FDA inspectional techniques to identify and implement the main ingredients of a good CAPA system
    -Evaluate effectiveness, suitability and adaptability of implemented solutions/corrective actions
    -Receive a tool box of methods to assist you in knowing if you have a comprehensive, bullet proof CAPA System
    -To investigate true root causes of problems and to evaluate and prioritize solutions
    -Problem solving methods to help you asses which is best for your situation
    -Develop successful implementation plans
    -Differentiate between corrective and preventative actions
    -Understand where an issue can be localized or must be evaluated for systemic effect
    Perform risk assessments effectively
    -Understand where companies miss the mark in triggering, investigating and executing CAPAs
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