Lean Sigma

Your customers demand the best to ensure their loved ones receive safe and effective products.

The regulators expect compliance to ever increasing regulatory requirements.

Your business needs efficient and effective processes for strong business results.
  • Failure Investigation
  • CAPA and problem resolution
  • Validation
  • Production and Process Controls
  • Design Control
  • CAPA
  • Recall Management
  • Six Sigma Tools
  • Supplier Quality
  • Complaint Analysis
  • Risk Mitigation
  • Quality System Establishment
  • Quality System Auditing
  • Gap Analysis
  • Due Diligence
  • Predicitive Compliance
  • Management Review
  • FDA inspection readiness
  • Notified Body inspection readiness
  • Quality Systems Improvement
  • 483 Response
  • Warning Letter Response
  • CAPA
  • Six Sigma Tools
  • Lean Solutions
  • Management Review
  • Training and Education
  • Process Improvement
  • Strategic Planning
  • Quality Improvement Mapping
*Susanne has worked in many, many countries throughout the world and is able to travel for you.