Systems GxP, data integrity, quality, validation
Medical Device Software GxP Compliance (1 day)
Objectives of internship
- Know and understand the applicable requirements for GxP regulatory compliance of computerized medical devices and for computerized systems participating in the Quality of medical devices.
- Acquire the methodological principles recommended by regulatory bodies for GxP (CE, FDA) compliance of computerized medical device systems.
- Know and understand the differences between CE requirements and FDA requirements for computerized medical devices and for computerized medical device accessories.
- Course based on the guidelines of the FDA (Part 11), NB-MED and G-MED, ISO14971, iec62304, ISO / TR 80002-2
- Concrete case studies
- Work in sub-groups
- Presentation and submission of a summary document
Production, IT, Quality assurance and validation services
Dates and costs 2021
Date: Contact us
Cost: € 680 excluding VAT including breaks and lunch
1 — REMINDER OF THE EUROPEAN AND AMERICAN REGULATORY ENVIRONMENT
- Applicable directives: 98/79 / CE, 93/42 / CEE, 90 / 385CEE, 21CFR Part 820, 21CFR Part 11, ISO13485, ISO14971, IEC 62304, ISO / TR 80002-2
- Applicable recommendations and guides: NB-MED / 2.2 / Rec4, FDA General principles of software validation for medical devices, GAMP5
- Organizations: G-MED, ANSM, FDA
- Key points of specific software requirements
2 — METHOD OF DETERMINING THE APPLICABILITY OF FDA REQUIREMENTS AND CE MARKING OF SOFTWARE
- Classification of software according to CE Mark and IEC 62304 and ISO / TR 80002-2 standards
- Good practices specific to software according to GAMP 5, standards IEC 62304 and ISO / TR 80002-2, 21 CFR Part 11: Quality process to control the software life cycle, Risk Analysis approach, Design, Validation, Maintenance
- Risks specific to software identified and monitored during inspections
3 — PROVEN METHOD OF VALIDATION OF SOFTWARE ACCORDING TO GAMP5
- Principles, tasks and activities
- Specifications: user, functional and design
- Risk analysis based on ISO14971
- Qualification, verifications, Tests
- Maintenance, change management, security and operational continuity
4 — DIFFERENCES BETWEEN EU REQUIREMENTS AND FDA REQUIREMENTS
Pharmasys is an approved organization (activity declaration number: 11 91 0806691) and listed in Datadock. It is therefore quite possible to go through your OPCA for the financing of the latter. You will find all the information you need to create your request for assistance in the training contract that will be sent to you.
We are at your disposal for any request for additional information.
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