Surviving an FDA Sponsor Inspection - Training for Success

Surviving an FDA Sponsor Inspection - Training for Success is an online event dedicated to case study derived from actual inspections wherein FDA performed a sponsor site inspection .

Surviving an FDA Sponsor Inspection - Training for Success covers topics such as:

  • FDA inspectional procedures; What sponsor staff are audit targets and how FDA inspections are performed
  • FDA sponsor inspection objectives and perspectives
  • Sponsor SOP and TMF options that work and do not work toward complying with FDA documentation requirement
  • The impact of CRO contractual delegation of project responsibilities on sponsor regulatory obligations
  • Typical and common FDA questions and how not to respond
  • Audit of sponsor records and training of sponsor staff as a positive step in preparing for the inspection

Surviving an FDA Sponsor Inspection - Training for Success intended for:

  • CQA
  • Clinical operations, CRA
  • Regulatory personnel
  • Investigators and research management staff
  • Director and upper level pharma research management
  • Regulatory Affairs
  • Clinical Project Manager
  • Trial Master File Manager
  • Compliance Manager

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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