Conference & Events
Event Details
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.
Date: 03 May 2012 08:00 - 04 May 2012 17:00
Event Subject(s):
Biosciences
Education
General
Venue
San Francisco, Marriott Marquis Downtown
San Francisco
United States of America
Useful link:
http://www.globalcompliancepanel.com/control/s_product/...
Organiser Information
Organiser(s): GlobalCompliancePanel
Contact for Event Information
Name : Mr Event coordinator
Address:
Marriott Marquis Downtown
San Francisco
United States of America
Tel:
8004479407
Fax:
3022886884
Email:
support@globalcompliancepanel.com
Contact Useful link:
http://www.globalcompliancepanel.com
Additional Information
Speaker Information:
Angela Bazigos is the CEO of Touchstone Technologies Silicon Valley, Inc. an FDA Compliance company. She has almost 30 years experience in the Lifesciences industry and has applied for patents aimed at speeding up Software Compliance. She is a member of the SQA CVIC (Society of Quality Assurance Computer Validation Initiative Committee), DIA and RAPS and teaches classes on 21 CFR 11, Computer Systems Validation, Compliance Strategy and Project Management. More recently, Ms. Bazigos was selected to co-author Computerized Systems In Clinical Research / Current Data Quality and Data Integrity Concepts with FDA, DIA and Academia.
Useful link:
http://www.globalcompliancepanel.com/control/s_product/...
Other information:
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
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@globalcompliancepanel.com
GlobalCompliancePanel
1000 N West Street, Suite 1200,
Wilmington, DE 19801, USA
