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I love risk, and risk is something I live in every single day. I think it’s really important to understand that when people talk about risk and FDA risk management, it’s not about the elimination of all risk. It’s almost impossible to eliminate all risk. We get out of bed each day, and as soon as we hit the floor, we experience risk.

What is critically important for companies to do, is to understand the drivers of risk. Understand where risk flows from, and to manage that risk and prioritize that risk, such that some risk is really important to address, and we have managed it, controlled it, and mitigated it to the extent possible… and some risk is really, you know, just not all that important. That’s really important for a company to do, because no company has infinite resources.

So regardless of whether you’re talking about a regulatory submission, or you’re talking about building controls, or quality systems, or a new product introduction… you know, it’s all about risk. Telling that story of where the risk flows from, what are the characteristics, what’s the likelihood, the probability, and using good risk models to quantify that risk and create relative risks is really important for companies to get a handle on. And, if they’re not good with risk management, they need help to build those risk models such that they can explain both internally, to their own internal stakeholders and to the external parties, in particular the regulators, what is the risk considerations they should be looking at.

What the video on YOUTUBE or READ MORE from Executive Platforms.

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®
      • Quality Culture Assessment
      • Product Quality Consulting
      • Operational Efficiency/Compliance Effectiveness
      • 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
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      • 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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