RS NESS ACADEMY
- Alon Steiniz - R.S NESS Academy Manager
- alons@rs-ness.com
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