© 2021 by RS-Ness Engineering, Projects & Validations LTD

RS NESS ACADEMY

Biotechnology & Pharma

Medical Device

Medical Cannabis

  • Cleanroom Seminar
  • Calibration
  • Shipping Validation
  • Process validation
  • Equipment validation
  • Systems validation
  • Test method validation
  • Sterilization Validation
  • CSV Computerized Systems Validation
  •  Water Systems ISO 22519
  • Project Management seminar
  •  cGMP Yearly Training
  • Introduction to DMF and CEP
  •  21 CFR Part 11 Compliance
  • QMS for ISO 13485
  • Clean Room Seminar
  • Test Method for Aseptic and Sterile Product
  • How to establish an Aseptic Process
  • Project Management Workshop
  • cGMP Yearly Training
  • Introduction to DMF (FDA) & CEP (EDQM)
  • Risk Management Process -ISO-14971 
  •  Sterilization Methods 
  • CSV – Computerized Software Validation
  •  Shipping Validation Seminar 
  • Design Control 
  • MDR Technical Documentation & FDA Premarket Notification 
  • 510(k)
  •  Usability (Per IEC 62304 and ISO 62366)
  • UDI Requirements
  • PPAP
  • Calibration for Medical Device
  • Design Verification &  Design Validation (V&V)
  • 21 CFR Part 11 Compliance
medical canabis
  • 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,  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

For more information please contact us

  • For more information please contact us