Validation And 21 Cfr Part 11 Compliance Of Computer Systems - India Seminar 2012 At Delhi

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.

Seminar 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

DATE AND VENUE:

12th and 13th April, 2012 at Delhi

Conference Timings: 9:00 am - 6:00 pm

Price Rs20000

Contact Information:

Event Coordinator

Toll free: 1800 425 9409

Phone number: +91 80-3221-3341 / +91 80-3247-3696 /

+91 80-3221-3329.

FAX : +91 80-2642-1483

Email: customersupport@globalcompliancepanel.com

GlobalCompliancePanel

NetZealous Services India Pvt. Ltd.

4th Floor, A, Block, Brigade Software Park,

Banashankari 2nd stage,

Bangalore-560070. INDIA.

http://www.globalcompliancepanel.com/control/in_21cfr_delhi

by: GlobalCompliancePanel

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