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

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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