R.S 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

• 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

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• For more information please contact us