Global
CompliancePanel
Knowledge, a Way Forward
2-day In-person Seminar:
Validation and 21 CFR 11 Compliance of Computer Systems:
Intermediate to Advanced
Price
Denmark
(Without Stay) Price:
May 9th & 10th, 2016
9:00 AM to 6:00 PM
$1,295.00
(Seminar for One Delegate)
(With Stay) Price:
$1,695.00
(Seminar for One Delegate)
Register now and save $200. (Early Bird)
Angela Bazigos
CEO, Touchstone Technologies Silicon Valley
**Please note the registration will be closed 2 days
(48 Hours) prior to the date of the seminar.
Angela Bazigos, is the CEO of Touchstone
Technologies Silicon Valley, Inc. "Your Passport to Compliance". She
has 30 years of experience in the Lifesciences industry spanning
Seminar Pricing Includes (With Stay)
Project Management, Quality Assurance and Regulatory Affairs and has
a patent aimed at speeding up Software Compliance.
Ms Bazigos is a member of the SQA CVIC (Society of Quality
2 Days Stay
Assurance Computer Validation Initiative Committee), ASQ, DIA and
RAPS and consults to investment groups on Lifesciences investments
Pick-up and Drop Facility (Nearest
Airport)
Overview:
Break-Fast and Lunch
Computer Systems Validation (CSV) also known as Software Validation is
High Tea
all-pervasive in the Life Sciences Industry. It is a requirement of all the
predicate rules, as well as 21 CFR 11 and Annex 11. However, unless
one knows how to implement CSV, it is often very hard to detect the
requirement for CSV, and very hard to determine what needs to be done,
to meet domestic and / or international regulations or business continuity
requirements. In addition, the FDA has stepped up 21 CFR 11 inspections
that include CSV.
This course will build on the Validation and 21 CFR 11 Compliance Basic
Course, to give hands on experience on executing on the computer
systems validation of a system, and to discuss related activities such as
Validation Master Plan, Infrastructure Qualication, Project Management
Pack of 3 Webinars will be
provided which has been done in
the past on similar subject
Global
CompliancePanel
2-day In-person Seminar:
Validation and 21 CFR 11 Compliance of Computer Systems:
Intermediate to Advanced
Why should you attend:
Industries:
VP of IT
Pharmaceuticals
Director of IT
Biotech
Quality Managers
Project Managers (for CSV / IT)
Medical Device
Radiological Health
Blood Products
Validation Specialists
Database Administrators
Companion Animals
Food
System Administrators
Cosmetics
Directors / Senior Directors of Discovery
Tobacco
AGENDA:
Day One
Day Two
Lecture 1: Introduction / Background
Lecture 5: CSV Detailed Study (Cont'd)
Introductions / Participants' Understanding
Participants' Objectives for the Course (Please
come prepared to discuss)
Lecture 2: Requirements at a High Level
Types of Requirements
Traceability Matrix
Verication and Testing
Exercise Creating Validation Scripts
Exercise Creating Traceability Matrix
Lecture 6: Other Documents
Validation Plan
Difference between User Requirements &
Functional Requirements
Test Protocols
Test Reports
Lecture 3: Detailed Requirements Study
Validation Report
Gathering Requirements
Entity Relationship Diagram
Process Decomposition
Risk Assessment for Requirements
Validation Registry
Lecture 7: Special Topics
Project Management for CSV
Infrastructure for CSV
Process Decomposition
Exercise on how to create Requirements
Lecture 4: Design
Design Specications
Selecting software for 21 CFR 11
Compliance
Test Tools for CSV
Lecture 8: Change Control & Business Continuity
Software Conguration and Build
Change Control
Exercise on how to create Design
Specications
Implementing Business Continuity for CSV
2-day In-person Seminar:
Global
CompliancePanel
Validation and 21 CFR 11 Compliance of Computer Systems:
Intermediate to Advanced
What You will get
Group Participation
10%
2 Attendees to get offer
20%
3 to 6 Attendees to get offer
25%
30%
Learning Objectives
Participation certicates
Interactive sessions with the US expert
Post event email assistance to your queries.
Special price on future purchase of web
7 to 10 Attendees to get offer
10+ Attendees to get offer
Payment Option
based trainings.
Credit Card: Use the Link to make Payment by
Visa/Master/American Express card click on the
register now link
Special price on future consulting or expertise
services.
Check: Kindly make the check payable to
NetZealous DBA GlobalCompliancePanel and
mailed to 161 Mission Falls Lane, Suite 216,
GlobalCompliancePanel.
Fremont, CA 94539, USA
PO: Please drop an email to
[email protected] or call the
Special price on future seminars by
Seminar Kit includes presentation handout,
our toll free +1-800-447-9407 for the invoice and
ID card, brochure, trainings catalog, notepad
you may fax the PO to 302 288 6884
and pen.
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Networking with industry's top notch professionals
information
Contact Information: Event Coordinator
161 Mission Falls Lane, Suite 216,
Kindly get in touch with us for any help or
information.
Fremont, CA 94539, USA
Look forward to meeting you at the seminar
NetZealous LLC, DBA GlobalComplianePanel
Toll free: +1-800-447-9407
Fax: 302 288 6884
Email:
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