RS NESS ACADEMY

Design Control

  • Design planning
  • Input, Output,
  • Device Master Record (DMR) and Device History Record (DHR)
  • Design transfer,
  • Design verification and Design validation
  • Design History File (DHF)

Validation

  • Shipping Validation
  • Process validation
  • Equipment validation
  • Systems validation
  • Test method validation
  • Sterilization Validation
  • Computerized Systems Validation

MDSAP/ MDR

  • Auditors expectations
  • From ISO 13485 to MDSAP/MDR
  • Support in readiness activities

Digital Health

  • 21 CFR Part 11 Compliance

Medical Cannabis

  • Design, establishment and certification of a medical cannabis manufacture
  • Quality assurance – Planning and establishing a QMS that meet IMC / GMP & EU / GMP requirements
  • Validation: structure, systems, equipment, and processes: cleaning, shipping.
  • Regulation – Regulatory aspects required for the establishment and certification of a plant
  • Laboratories – Emphasis on the establishment and testing of farm / factory products
  • Clinical trials in the world of medical cannabis
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