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.

Teaching methods

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

Staff concerned

Production, IT, Quality assurance and validation services

Dates and costs 2022

Date: Contact us

Cost: € 680 excluding VAT including breaks and lunch

DETAILED PROGRAM

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

Pre-registration:

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Message

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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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As part of our development, we are strengthening our teams.

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PHARMASYS GROUP
36, Place Nelson Mandela
91300 MASSY
Tel : +33 (0)1 69 35 05 43
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