Training programs are developed to comply with all client requirements and, as appropriate, regulatory requirements for annual training as well. This list is not exhaustive and training may be customized to client needs. Neozene has a number of qualified subject matter experts in all areas of regulatory and quality and may tailor training programs as needed. All training includes applicable training materials and statements of qualification by our trainers so they can be added to the client’s training record database as objective evidence for the qualification of the trainer.

  • Annual GMP Overview / Update
  • Quality System Requirements (FDA, ISO, and all applicable countries)
  • UDI / Labeling Systems
  • MDSAP / ISO 13485:2016 (ISO 13485:2016 Certification preparation)
  • Good Documentation Practices
  • Change Controls
  • Design Controls including Design Risk Management
  • Risk Management (product, process, or use case specific or general system-wide)
  • Root Cause Investigations and Failure Analyses including use of standardized RCA tools
  • Complaint Handling including reportability requirements and prioritization
  • Nonconformances and CAPAs for ensuring conformance with all applicable regulations
  • Quality Auditing (our qualified personnel can lead audits and/or train your internal auditors)
  • Compliance Readiness / How to Interface with FDA investigators
  • Human Factors Engineering / Use Case Engineering
  • Electrical Safety and applicable standards (UL, ISO, etc.)
  • Supplier Qualification Programs (including product qualification and ASL requirements)