Webinar
How Does Effective Quality Planning and Preparation Improve Your Regulatory Compliance
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April 22, 2025

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11:00am - 12:00pm

(GMT-04:00)

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This webinar explores how effective quality planning and preparation can enhance regulatory compliance for Pharma and Medtech companies. It covers the risks of receiving an FDA 483 or a Notified Body citation and highlights proactive steps like gap assessments and follow-up sessions to identify potential issues. Rather than relying solely on mock inspections, the session emphasizes strategic risk mitigation and expert preparedness to ensure compliance success.

Key Takeaways:

  • Organizational readiness and SME training are crucial for demonstrating regulatory compliance in audits and inspections.
  • Treat audits as “finals” rather than practice runs to ensure thorough preparation.
  • Plan effective post-inspection corrective actions and communicate realistic timelines to regulatory bodies.

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