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 systems that work day-to-day across clinical and manufacturing environments,with evidence that holds up under FDA/EMA/MHRA scrutiny.

What I do

Inspection readiness (FDA/EMA/MHRA)

  • Readiness planning,evidence strategy,and inspection storyboards that hold up under questioning
  • Mock inspections/audits and SME coaching
  • Practical documentation and governance that reduces scramble and rework

GCP/GMP quality systems that scale

  • Deviations,CAPA,change control,risk management,training,and quality metrics
  • Phase-appropriate QMS design (build what you need now,with an upgrade path)
  • Cross-functional alignment across Clinical Ops,PV,CMC/Tech Ops,QA,and IT

Vendor oversight (CROs,CDMOs,labs)

  • Qualification and monitoring programs
  • Quality agreements/QTA support
  • Issue management: signals->investigations->CAPA effectiveness->trend prevention

How I help (typical engagements)

  • Rapid assessment+plan (30/60/90)
  • CAPA remediation+effectiveness with evidence that survives scrutiny
  • Inspection readiness support (readiness packs,storyboards,mock inspections)
  • Vendor quality oversight programs that improve control without slowing the business

Adjacent regulated work

My core work is biopharma and clinical/manufacturing GxP. I have also supported adjacent regulated environments where the same fundamentals matter: documented controls,traceability,validated decisions,and defensible records.

  • Food+beverage and winery operations (quality programs,sanitation controls,traceability,documentation)
  • Cosmetics/personal care (supplier controls,documentation discipline,claims governance)
  • Other quality+compliance programs where “if it isn’t documented,it didn’t happen” is still true

Who this site is for

  • Teams building or upgrading GxP systems without overbuilding
  • Leaders who need inspection readiness that works day-to-day
  • Teams adopting new tools (including AI-enabled workflows) that need governance,monitoring,and traceability

Contact

Note: I write here in a personal capacity. Nothing on this site is legal,regulatory,or compliance advice.