Surviving an FDA Sponsor Inspection - Training for Success 2019

  • 19 Feb 2019
  • Webinar

Description

Surviving an FDA Sponsor Inspection - Training for Success 2019 is an event dedicated to case study derived from actual inspections wherein FDA performed a sponsor site inspection .

Surviving an FDA Sponsor Inspection - Training for Success 2019 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 2019 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

Past Events

Important

Please, check "Surviving an FDA Sponsor Inspection - Training for Success" official website for possible changes, before making any traveling arrangements

Event Categories

Government & Global Issues: Law & Regulations
Health & Medicine: Medical device, Pharma

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