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LIVE REVIEW: Managing The New Approach to FDA Inspections of Quality System Documentation

Inspection Management ProcessToday, FDA Investigators don’t just pore over your documents, they access your computer-based systems to obtain your information directly!  The old way of managing FDA Inspections, while still valid, needs to be updated.   This White Paper looks at traditional FDA Inspection approaches, the new “live review” approach, impacts from the “live review” approach, and how to best adapt to the “live review” approach.   Anyone involved in FDA inspections needs to read and understand this material, and determine how best to be prepared for this within their organization.

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  • Quality Management in the Third-Party Supply Chain
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  • Services
    • Inspection Readiness & Enforcement
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      • Audits & Assessments
      • FDA Enforcement Response/Remediation
    • FDA Quality Consulting
      • Quality System & Compliance Turnarounds / Restructuring
      • Training / Coaching
      • Quality & Compliance Computer-Based Systems
      • External Supply Chain Compliance
      • Part 11 & Computer Systems Validation
      • Turnkey Quality Systems
    • Quality Assurance and Engineering
      • CRPN Quality Roadmap®
      • Quality Culture Assessment
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      • Project/Program Management
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      • Corporate Compliance Programs
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    • FDA Regulatory Consultants
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      • REMS (Risk Evaluation And Mitigation Strategies)
      • Mergers / Acquisitions / Licensing
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      • Rapid Turnaround
  • Innovative Solutions
    • Writing for Compliance®
    • CRPN Quality Roadmap®
    • Quality Pulse®
    • IEEP
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  • Success Stories
  • Industries
    • Biopharmaceuticals
    • Cannabis/CBD
    • Cell & Gene Therapies
    • Combination Products
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    • Dietary Supplements
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  • Contact Us

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