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

support@globalcompliancepanel.com 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.

Wire Transfer: Please drop an email to

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Networking with industry's top notch professionals

information

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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: support@globalcompliancepanel.com

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