Your event should be here ! To publish, manage, promote... To learn or to be formed ... Online registrations

Site language : English - Français
Ref : 27514
Event :21 CFR Part 11 Conformance for Medical Devices

Date :Thursday July 12th, 2018

Location :9106 Seven Locks Road, Bethesda, Maryland 20817
Bethesda, United States

Type :Congress - International audience

Accreditation :--


 

Further information

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

Location

Map and directions
Congress address :
9106 Seven Locks Road, Bethesda, Maryland 20817
Bethesda
United States
tel : 1-844-216-5230.
Map and directions

Further information

To access the information you need to be connected. Creating an account is easy and free!

Log to your account
Register on Doctorama

Announcer





Compliance Training Panel
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 [...]

Other events from Compliance Training Panel

Presentation sheet from Compliance Training Panel

Details

21 CFR Part 11 Conformance for Medical Devices Medicine
https://www.compliancetrainingpanel.com/webinar/speaker?uiotsdp=61
Professionals, 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

Other

For more information on 21 CFR Part 11 Conformance for Medical Devices, plsase contactr Compliance Training Panel

To display announcer website, obtain a letter of invitation, you must be logged

Log to my account
Register on Doctorama


Recommend this event