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Overview: In December 2010 the FDA changed the way it does audits to include 21 CFR 11 add-on inspections. Very little is known about this, yet the FDA has already issued citations on the subject. This Webinar will present the latest on FDA thinking (with slides directly from the FDA's Office of Compliance), discuss how these inspections will impact both your company an the industry, and provide guidance on how your company can ensure that they have a successful inspection. 

Interactive course to cover all areas of 21 CFR 11 and how to include 21 CFR 11 requirements in computer systems validation. Will include exercises where the attendees will build all the deliverables for a computer system using the 21 CFR 11 principles and requirements. Finally, a fun ‘Jeopardy’ quiz will be used to test the participants’ knowledge  

Areas Covered in the Session:

Day 1, May 3rd, 2012 

Lecture 1: Introduction to 21 CFR 11

• History of 21 CFR 11
• Current Status of 21 CFR 11
• 21 CFR 11 Overview
• 21 CFR 11.10 (a)-(k)
• 21 CFR 11.30
• 21 CFR 11.50
• 21 CFR 11.70
• 21 CFR 11.100
• 21 CFR 11.200
• 21 CFR 11.300
• The FDA’s Requirements for 21 CFR 11
• FDA’s Add-On Inspections for 21 CFR 11

• Risk Assessment
• Vendor Audit
• Validation Plan
• Requirements Specification
• Design Specification

• Installation Qualification (IQ)
• Operational Qualification (OQ)
• Performance Qualification (PQ)
• Traceability Matrix
• Validation Summary Report
• Validation Registry
• SOPs
• 21 CFR 11 Audit

• Create ALL Deliverables for a Laboratory Information Management System (LIMS)
• Jeopardy - Test Your Knowledge

• Everybody using computers in FDA or regulated environments
• IT manager and staff
• QA managers and personnel
• Regulatory affairs
• Training departments
• Consultants
• Validation specialists
• Project Managers
• Vendors of COTS (Commercial Off The Shelf) systems in regulated industries
• Anyone dealing with electronic records and/or electronic signatures

Contact Information:

Event Coordinator

Toll free: 800-425-9409

Fax: 302-288-6884

Email: support@globalcompliancepanel.com

GlobalCompliancePanel
1000 N West Street, Suite 1200,
Wilmington, DE 19801, USA