The New ISO 13485:2016 and Comparison with 21CFR820 - How to Comply with both in the Same Organization 2018 is a webinar that covers topics such as:
- ISO 13485:2016 short review
- Brief review of regulations and standard: status and history
- Quality management system
- Principals
- Resource management
- Management responsibility
- Measurement, analysis and improvement
- Product realization
- Quality System Requirements
- FDA QSR (21CFR820) short review
- Document Controls
- Design Controls
- Identification and Traceability
- Purchasing Controls
- Acceptance activities
- Production and Process Controls
- Corrective and Preventive Action
- Nonconforming Product
- Handling, Storage, Distribution, and Installation
- Labeling and Packaging Control
- Servicing
- Records
- Comparison between both QMS
- Statistical Techniques
- Variances between both
- Common features
- Comparison between terms
- Terms/ vocabulary
The New ISO 13485:2016 and Comparison with 21CFR820 - How to Comply with both in the Same Organization 2018 is intended for:
- Laboratory Managers
- Medical Devices Quality Personal (QA and QC)
- Quality Control Staff
- R&D Researchers of Medical Devices and Combined Products
- Regulatory Affairs (RA) Staff
