2012 - Validation and 21 CFR Part 11 Compliance of Computer Systems - US Seminar 2012 at San Francisco

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
Lecture 2: 21 CFR 11.10 (a) Computer Systems Validation Deliverables
Risk Assessment
Vendor Audit
Validation Plan
Requirements Specification
Design Specification
Day 2, May 3rd, 2012
Lecture 3: 21 CFR 11.10 (a) Computer Systems Validation Deliverables
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
Traceability Matrix
Validation Summary Report
Validation Registry
SOPs
21 CFR 11 Audit
Lecture 4: 21 CFR 11.10 (A) Computer Systems Validation Deliverables Exercise
Create ALL Deliverables for a Laboratory Information Management System (LIMS)
Jeopardy - Test Your Knowledge
Who will benefit:
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-AT-globalcompliancepanel.com
http://www.globalcompliancepanel.com
Price: $1,495.00
GlobalCompliancePanel
1000 N West Street, Suite 1200,
Wilmington, DE 19801, USA