Validation and 21 CFR Part 11 Compliance of Computer Systems - India Seminar 2012 at Bangalore

Overview: This course 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 and 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
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:
9th and 10th April, 2012 at Bangalore
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: [email protected]
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_bangalore