Management system development
  • System gap analysis
  • Implementation planning and execution
  • FDA regulations
  • ISO standards
  • Baldrige criteria
  • Auditing - regulatory and standards compliance
  • Product quality assurance
  • Innovation process and tools
  • Software development methodologies
  • Document Management Systems
Training and communication
  • Quality system, regulatory/medical and process writing
  • Innovation management concepts
  • Training materials
  • Technical standards and regulations