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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