Preparing for an FDA Preapproval Inspection - Webinar CD/Transcript

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Preparing for an FDA Preapproval Inspection

Industry expert David L. Chesney explains how to prepare for and manage preapproval inspections. In 90 minutes he will cover:

  • Why you need to ensure a successful inspection
  • Guidance on inspection activities — from drug development to QA controls to document reviews
  • The benefits of a risk-based approach to inspections and what it entails
  • How to prepare for an inspection and what documents are needed
  • How to best handle document requests to avoid problems

Order today and learn how to prepare for your preapproval inspection and avoid misunderstandings and delays.

  • Compliance Officers
  • Executive Management
  • General/ Corporate Counsel
  • Regulatory/ Legislative Affairs Professionals
  • Risk Management Specialist
  • Sales and Marketing Personnel
  • Training Personnel
  • Medical Science Liaisons
  • Outside Attorneys

David L. Chesney is the Principal and General Manager of DL Chesney Consulting, LLC. He provides consulting services to a worldwide client base, including GMP, GCP, inspection readiness and post-inspection remediation assistance. Previously he served 23 years with the FDA, and 21 years with PAREXEL International, including 19 years leading the Strategic Compliance Consulting group within PAREXEL Consulting.