Complaint Handling and Management: From Receipt to Trending 2016

  • 25-26 Jul 2016
  • Cape Town, South Africa

Description

Topics
  • Ways to train employees in view of the inspection
  • How a firm should prepare for an FDA inspection
  • How to interact with the investigator-DO`s and DON`T`s
  • How to ensure that required documentation is in place
  • How to reply to 483`s and warning letters
  • What companies should do when the inspection ends
  • Post inspection actions
  • Legal implications of non-compliance
  • The emphasis on systems-based inspections...and the IOM and other crucial FDA reference documents
  • Why inspections are conducted and by what statutory authority
  • Understand and apply the do`s and don`ts and comprehend that preparation is the key to success
  • What is subject to FDA purview and what`s off-limits
  • What you need to know and do to prepare for, during and even after the inspection...and why your inspection response team is key
  • What are the prohibited "Acts" and the enforcement categories that you need to deal with
  • How to respond to findings and facilitating the documentation and remediation process...and reaching final closure
  • The company`s Inspection Plan (SOP) can make or break the inspection depending on how to use it and training your personnel
  • Define clear responsibilities, roles and goals for personnel involved in SOP development
Who should Attend

Senior attendees from:

  • Dietary Supplements
    • Nutraceutical
    • Food
  • FDA regulated Industries
    • Pharmaceuticals
    • Medical Device
    • Clinical
  • Healthcare IT
    • Validation
    • Technical Services
    • Engineering

Past Events

Important

Please, check "Complaint Handling and Management: From Receipt to Trending" official website for possible changes, before making any traveling arrangements

Event Categories

Health & Medicine: Healthcare, Medical device, Pharma
Industry: Beauty & Natural products, Food & Beverages
Science: Life Sciences & Biology

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