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Langue du site : Français - English
Réf : 27514
Evènement :21 CFR Part 11 Conformance for Medical Devices

Date :Jeudi 12 Juillet 2018

Lieu :9106 Seven Locks Road, Bethesda, Maryland 20817
Bethesda, Maryland, États-Unis

Type :Congrès - Audience Internationale

Accréditation :--


 

Informations

Objectives

This Webinar will explain what 21 CFR Part 11 is, why it is important to FDA regulated companies and how conformance to Part 11 differs from just having good IT security. Procedures for controlling electronic signatures and electronic records as described in the FDA Guidance will be explained. 

FDA regulated companies want to transition to electronic records for economy and efficiency. FDA, because of its concern for patient safety, wants to prevent electronic records from being compromised with possible resulting harm to the patient. 

FDA has set up regulations that address both data security and patient safety. We will show how 21 CFR part 11 considers both. 

The confusion over the original FDA regulation and its subsequent “selective enforcement” will be explained. FDA requirements for 21CFR Part 11 validation will be explained. the requirements are composed of technical and procedural aspects. open, closed and hybrid (paper and electronic) systems will be explained.
 

Speakers

Edwin Waldbusser

Lieu

Plan et itinéraire
Adresse du congrès :
9106 Seven Locks Road, Bethesda, Maryland 20817
Bethesda
Maryland, États-Unis
Tél : 1-844-216-5230.
Plan et itinéraire

Renseignements

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Description : Process capability and process performance indices are long-established metrics of a process ability to meet customer specifications. A Six Sigma process, in fact, has six process' standard deviations between the process nominal and the specification limits. If the process is centered on the nominal it will have two [...]

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Précisions

21 CFR Part 11 Conformance for Medical Devices Médecine
https://www.compliancetrainingpanel.com/webinar/speaker?uiotsdp=61
Professionnels, Origin of the regulation and changes in interpretation Electronic records Electronic signatures Data security Open, Closed and hybrid systems Validation methods Risk analysis
100 1 10
English

Divers

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