subject: Validation And 21 Cfr Part 11 Compliance Of Computer Systems - India Seminar 2012 At Bangalore [print this page] 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.
Agenda:
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
21 CFR 11.10 (A) COMPUTER SYSTEMS VALIDATION DELIVERABLES
Risk Assessment
Vendor Audit
Validation Plan
Requirements Specification
Design Specification
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
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
Angela Bazigos CEO, Touchstone Technologies Silicon Valley
Angela Bazigos is the CEO of Touchstone Technologies Silicon Valley, Inc. an FDA Compliance company. She has almost 30 years experience in the
Life sciences 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
