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Quality culture has been something that has been really hard to create tight, and kind of, geometric bounds around. But, in fact, it’s something that’s critically important for industry to understand how to essentially establish a measure of culture…because you really need to know where you are, such that you can achieve where you want to be.

Culture has been recognized by the Food and Drug Administration as being critically important…and both on the device and the pharmaceutical side… has been something that the Agency is looking at in their risk based inspection principles as making a cornerstone of how they want to determine what companies’ cultures’ are so they can determine what is it appropriate risk based inspection schedule.

…because they know that companies with good cultures perform better.

Filed Under: Achieving Compliance

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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®
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      • Project/Program Management
    • Corporate Compliance and Litigation
      • Corporate Compliance Programs
      • Interactions With Department Of Justice And The Courts
    • FDA Regulatory Consultants
      • Product Development / Submissions / Commercialization
      • REMS (Risk Evaluation And Mitigation Strategies)
      • Mergers / Acquisitions / Licensing
    • Quality, Compliance, Regulatory & Operations’ Staffing
      • Staffing
      • Talent Management
      • Rapid Turnaround
  • Innovative Solutions
    • Writing for Compliance®
    • CRPN Quality Roadmap®
    • Quality Pulse®
    • IEEP
    • REMS
  • Success Stories
  • Industries
    • Biopharmaceuticals
    • Cannabis/CBD
    • Cell & Gene Therapies
    • Combination Products
    • Cosmetics
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