Managing Domestic and Foreign FDA Inspections and the COVID-19 Impact

  • 27-28 Aug 2020
  • Online Event

Description

Managing Domestic and Foreign FDA Inspections and the COVID-19 Impact is an event dedicated to the factors used by the FDA to schedule inspections. You will learn how to predict what an FDA investigator will do .

Managing Domestic and Foreign FDA Inspections and the COVID-19 Impact covers topics such as:

  • Over products
  • FDA legal authority to inspect
  • Scientific/clinical studies
  • Over firm’s
  • Postmarket requirements
  • Premarket requirements
  • Inspection Procedures
  • FDA’s annual inspection work plan
  • FDA Training
  • FDA inspection Manuals
  • Refusals
  • Documenting violations
  • Recall procedures (What FDA expects from you.)
  • Human factors
  • FDA Center(s) Management
  • FDA Field Office Management
  • Inspectional observations (Form FDA-483)
  • The firm’s job
  • Responding to a Warning Letter
  • Responding to a 483
  • Follow up inspections
  • FDA enforcement actions
  • Foreign Inspections

Managing Domestic and Foreign FDA Inspections and the COVID-19 Impact intended for:

  • Quality Assurance Managers
  • Regulatory Affairs Directors
  • Manufacturing Directors and Managers
  • Quality Control Managers
  • Venture Capitalists
  • Product Risk Managers

Past Events

Important

Please, check "Managing Domestic and Foreign FDA Inspections and the COVID-19 Impact" official website for possible changes, before making any traveling arrangements

Event Categories

Government & Global Issues: Law & Regulations
Health & Medicine: COVID-19, Infectious diseases

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