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India Seminar 2012 at Bangalore GlobalCompliancePanel proudly presents its next India Seminar on
Validation and 21 CFR Part 11 Compliance of Computer Systems Overview
Angela Bazigos
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
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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 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.
Date and Venue more...
April 9th and 10th, 2012 - Bangalore
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Venue: TBD
For Sponsorship Seminar Agenda:
Timings: 9:00 am - 6:00 pm
Day 1 - 09th April 2012
Day 2 - 10th April 2012
Lecture 1: INTRODUCTION TO 21 CFR 11
Lecture 3: 21 CFR 11.10 (A) COMPUTER SYSTEMS VALIDATION DELIVERABLES l Installation Qualification (IQ) l Operational Qualification (OQ) l Performance Qualification (PQ) l Traceability Matrix l Validation Summary Report l Validation Registry l SOPs l 21 CFR 11 Audit
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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 4: 21 CFR 11.10 (A) COMPUTER SYSTEMS VALIDATION DELIVERABLES EXERCISE l
Lecture 2: 21 CFR 11.10 (A) COMPUTER SYSTEMS VALIDATION DELIVERABLES l l l l l
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Create ALL Deliverables for a Laboratory Information Management System (LIMS) 'Jeopardy' Test Your Knowledge
Risk Assessment Vendor Audit Validation Plan Requirements Specification Design Specification
Contact Information: Event-coordinator Phone number: +91 80-3247-3694 / +91 80-3201-4957 / Fax number: +91 8 0-2642-1483 Email:
customersupport@globalcompliancepanel.com GlobalCompliancePanel C/O NetZealous Services India Pvt. Ltd. 4th Floor, A, Block, Brigade Software Park, Banashankari 2nd stage, Bangalore-560070. INDIA
Pricing List Register By
Price INR
Savings
Between February 13th to March 04th
20,000
2,000
Between March 05th to April 8th
22,000
0
We will be able to accommodate limited number of attendees so if you and your colleagues would like to attend this training seminar, call us today at +91 80-3247-3694 / +91 80-3201-4957 to reserve your seat.
Download the Registration Form Best regards, Team GlobalCompliancePanel
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