The New ISO 13485:2016 and Comparison with 21CFR820 - How to Comply with both in the Same Organization 2018
16 Feb 2018
Webinar
Description
Topics
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
Who should Attend
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
Past Events
The New ISO 13485:2016 and Comparison with 21CFR820 - How to Comply with both in the Same Organization 2018 - 16 Feb 2018, Webinar (72924)
Important
Please, check "The New ISO 13485:2016 and Comparison with 21CFR820 - How to Comply with both in the Same Organization" official website for possible changes, before making any traveling arrangements
