Surviving an FDA Inspection: Understand the Do`s and Don`ts and the Ground Rules 2015

  • 10-11 Dec 2015
  • Courtyard Boston Logan Airport, MA, United States

Description

Surviving an FDA Inspection: Understand the Do`s and Don`ts and the Ground Rules 2015 is a seminar that covers topics such as:

  • 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

Surviving an FDA Inspection: Understand the Do`s and Don`ts and the Ground Rules 2015 is intended for attendees from regulated companies that are preparing for FDA inspections, including:

  • QA/QC/Compliance/Regulatory Affairs
  • All levels of Management for all departments
  • Engineering/Technical Services/Validation
  • Information Technology/Marketing & Sales
  • Operations and Manufacturing
  • Consultants

Past Events

Important

Please, check "Surviving an FDA Inspection: Understand the Do`s and Don`ts and the Ground Rules" official website for possible changes, before making any traveling arrangements

Event Categories

Education: E-learning
Health & Medicine: Healthcare, Hospitals & Clinics, Medical device, Medical laboratories, Medical technology, Nursing
Science: Health sciences

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