Developing solutions by transforming the way people think and feel about the way organization function.

A breadth and depth of knowledge in all aspects of organization management and development in lean cultural transformations.

These include both non-regulated and regulated industries including  cGMP, FDA, ISO, FDA environments.

Areas of accomplishments include:

  • Cultural transformation
  • 483 Remediation
  • Introduction and implementation of a lean manufacturing culture using the Toyota Production System as a model
  • ISO implementation
  • Cost reduction
  • New product introduction
  • Product development
  • Manufacturing development and management
  • Customer support and service
  • Quality systems development
  • Supply-chain integration
  • Time-compression, 3D printing  (rapid prototyping) technologies and techniques
  • OEM coordination as well as qualifying and negotiating with contract manufacturers

Helping companies to establish processes and procedures to work within FDA, ISO and other regulatory environments