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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.
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USA Seminar 2012 at San Francisco
Validation and 21 CFR Part 11 Compliance of Computer Systems
Angela Bazigosby
On 3rd and 4th May, 2012 at San Francisco
About GlobalCompliancePanel:
GlobalCompliancePanel is an online training provider of Regulatory and Quality compliance. We deliver a broad range of high
quality regulatory and compliance-related services.
At GlobalCompliancePanel, we offer extensive and high quality training for Risk Management, Regulatory Compliances,
Corporate Governance and Quality Management. We have been serving our customers for the past three years, during which we
have successfully completed over 350 training courses, from which more than 15,000 professionals have benefited. Many of these
sessions have had over 100 participants. Over 100 well-versed Experts from various industries with several decades of collective
experience are associated with us.
Our services benefit the Medical Devices, Pharmaceutical, Bio Technology, Food Safety, Financial Accounting Standards, and IT
Control & PCI Industries. Our clients can choose from any of these mediums - online seminars that are live, recorded or for group
viewing, workshops, live seminars and conferences, onsite trainings and consulting. Our clientele includes companies such as
J&J, Pfizer, Sanofi Aventis, Pall Corp, Abbott, Merck, Bayer, and Roche, some of which are Fortune 500 companies.
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Net Zealous
Angela BazigosCEO, Touchstone Technologies Silicon Valley
USA Seminar 2012 at San Francisco
About Speaker:Angela Bazigos is the CEO of Touchstone Technologies Silicon Valley, Inc. "Your Passport to Compliance".She has
30 years experience in the Lifesciences industry spanning project management, Quality Assurance and Regulatory
Affairs and has applied for patents aimed at speeding up Software Compliance.
She is a member SQA and PRCSQA as well as of the SQA CVIC (Society of Quality Assurance Computer Validation
Initiative Committee), DIA and RAPS and provides consulting services to Pharma / Biotech / Medical Device and
CRO industry on compliance matters, including strategy, submissions, quality assurance and remediations following
action by the FDA.She teaches classes on Compliance, 21 CFR 11, Computer Systems Validation, and Project
Management. More recently, Ms. Bazigos co-authored Computerized Systems In Clinical Research / Current Data
Quality and Data Integrity Concepts with FDA, DIA and Academia.
She is also on the board for UC Berkeley's Haas Business School for Executive Education in Life Sciences and on
the Stanford Registry for Women's Who's Who.
May 3rd and 4th, 2012 at San Francisco
Will be announced soon
Date and Venue:
Past Seminars
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Seminar Content: Conference timings: 9 AM PDT to 5 PM PDT
Day 1 - 3rd May 2012 Day 2 - 4th May 2012
USA Seminar 2012 at San Francisco
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
Why should you attend: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. This Training 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.
Course Description: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
www.globalcompliancepanel.com All rights are reserved © GlobalCompliancePanel.
How to Register:
v Register online. Use your American Express, Visa or MasterCard
v For group discount of more than 5 attendees call 800-447-9407
v Call +1 - 800-447-9407 or Fax your PO: 302-288-6884
v Mail your check to: NetZealous LLC DBA GLOBALCOMPLAINCEPANEL,
6552 Palisades Dr. Centreville, VA 20121
Contact Information:Event Coordinator
Toll free: 1800 447 9407
Fax: 302 288 6884
Email: [email protected]
GlobalCompliancePanel
NetZealous
1000 N West Street,
Suite 1200, Wilmington,
DE 19801..
Kindly get in touch with us for any help or information.
Look forward to meeting you at the seminar
Team GlobalCompliancePanel
USA Seminar 2012 at San Francisco
1. Learning Objectives
2. Participation certificates
3. Interactive sessions with the US expert
4. Post event email assistance to your queries.
5. Special price on future purchase of web based trainings.
6. Special price on future consulting or expertise services.
7. Special price on future seminars by GlobalCompliancePanel.
8. Seminar Kit – includes presentation handout, ID card, brochure, trainings catalog,
notepad and pen.
9. Networking with industry's top notch professionals
Companies that will benefit:
† Pharmaceutical Development and Manufacturing
† Active pharmaceutical Ingredients Industry
† IT/IS Service providers
† Contract laboratories
† Medical device companies
† CROs
† CMOs
Pricing List:
1. Price for One Delegate pass
$1895 (Between March 23th to April 25th)
-----------------------------------------
2. Early bird price for one Delegate pass $1695
(Between February 16th to March 22th)
-----------------------------------------
3. For discounts on multiple registrations, contact customer care at 1800 447 9407
Professionals 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
What you get:
