Managing Your FDA Inspection: Before, During and After

Description

The Managing Your FDA Inspection: Before, During and After is a conference that covers topics such as:

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

The Managing Your FDA Inspection: Before, During and After brings together:

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

Future Events

Past Events

Important

Please, check the official conference website for possible changes, before you make any traveling arrangements

Prices are for evaluation only.

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