Kenneth Brandt
I work in GCP+GxP quality systems and quality operations with 20+ years across biopharma, sterile manufacturing, biologics/CDMOs, and consulting.
I help teams build inspection-ready quality systems that work day-to-day across clinical and manufacturing, with strong vendor oversight, CAPA effectiveness, and phase-appropriate QMS design.
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Featured
- Inspection Readiness War Room: The Evidence Map That Ends the Scramble
- Audit Trails + Log Retention for AI in GxP: A Practical Starter Checklist
- Model Drift in GxP: What It Is (and Isn’t) + A Practical Monitoring Playbook
- Control Strategy Without the Jargon: Control Layers That Survive an Audit
- Alert+Action Limits: A Starter Checklist
- Audit Trails+Log Retention: A Starter Checklist
Contact
- LinkedIn: linkedin.com/in/kennethjbrandt
- Email: contact@kennethjbrandt.com
Posts
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Audit Trails+Log Retention: A Starter Checklist for Inspection Readiness
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Alert+Action Limits: A Starter Checklist for GxP Monitoring
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Model Drift in GxP: What It Is (and Isn’t) + A Practical Monitoring Playbook
-
Control Strategy Without the Jargon: Control Layers That Survive an Audit
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