Webinar Information


21 CFR Part 11 Conformance for Medical Devices


21 CFR Part 11 Conformance for Medical Devices, Washington, Maryland, United States
Webinar Title
21 CFR Part 11 Conformance for Medical Devices
Event Type
Webinar
Webinar Date
12-07-2018
Last Date for Applying
12-07-2018
Location
Washington, Maryland, United States

Publish / Maintain / Marketing / Hosted By
Organization Name / Organize By
Compliance Training Panel
Organizing/Related Departments
R&D
Organization Type
Organization/Company
Webinar Category
Technical
Webinar Level
International
Related Industries

Medical/Healthcare/Hospital

Location
Washington, Maryland, United States

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.

Others Details

Venue:Online Speaker Name:Edwin Waldbusser Price : $ 229 Thursday, July 12, 2018 EST 13:00 Duration : 60 Minutes Tel: +1-844-216-5230 Email: support@compliancetrainingpanel.com

Registration Fees
Available
Registration Fees Details
Price : $ 229
Registration Ways
Website
Address/Venue
Online 
Official Email ID
support@compliancetrainingpanel.com
Contact
Sam Miller

Online

support@compliancetrainingpanel.com