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FDA Data Integrity for Computerized Systems 2017 | 21 CFR 11

Wednesday, Apr 19, 2017 at 9:00AM - Thursday, Apr 20, 2017 at 6:00PM

Zurich, Switzerland

  • Apr 2017

    19 Wed


  • Apr 2017

    20 Thu


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FDA Data Integrity for Computerized Systems 2017 | 21 CFR 11

Wednesday, Apr 19, 2017 at 9:00AM - Thursday, Apr 20, 2017 at 6:00PM

Zurich, Switzerland, SC

No tickets available


"FDA Data Integrity for Computerized Systems: Combat the Misconceptions of
21 CFR 11 & Annex 11" has been pre-approved by RAPS as eligible for up
to 12 credits towards a participant's RAC recertification upon full completion.


The Problem:

We have all heard of Data Integrity but do you really understand
what it is? Do you understand how 21 CFR 11 and Annex 11 fit into this picture?
Specifically, can you answer questions on the following?

  • Evolution of 21
    CFR Part 11 and Annex 11 and Why they are Back in the News
  • Overview and
    Key Requirements of Part 11 & Annex 11
  • How to use a
    Risk Based Assessment to reduce work while still achieving Data Integrity and
  • How FDA &
    other Regulatory Authorities Inspect Computerized Systems for Data Integrity?

I often refer to 21 CFR 11 and Annex 11 as Good Software
Engineering with the Documentation on Steroids! However, unless one knows how
to implement Data Integrity, it is often very hard to apply requirements for
DATA INTEGRITY to computerized system, and very hard to determine what needs to
be done, to meet domestic and / or international regulations or business
continuity requirements. In addition, the agencies have stepped up data
integrity inspections and the number of citations on the subject is

This course is appropriate for beginner and experienced person
alike. The topics will build on each other and will give you the latest trends
in our heavily regulated industry and how to make it easy for yourself while
still achieving data integrity.

This is a very hands-on class and the attendees will be given
take away templates that will enable them to build a complete package to meet
Data Integrity Requirements for Computerized Systems

The Seminar:

This Hands-On course will provide the attendees with more
detailed experience on validation / 21 CFR 11 compliance of a computer system,
as well as details for activities associated with computer systems validation
as follows:

  1. What is Data
    Integrity and how is it implemented
  2. How to use Risk
    Based Assessments to reduce work while still achieving Data Integrity and
  3. Data Integrity
    Frequently Asked Questions
  4. Validation
    Master Plan
  5. Risk Based Assessment
  6. Complete
    Validation for a System (software development lifecycle)
  7. Automated Test
  8. Infrastructure
  9. Change Control
  10. SOPs

Who will

  • VP of IT
  • Director of IT
  • Quality
  • Project
    Managers (for DATA INTEGRITY / IT)
  • Validation
  • Database
  • System
  • Directors /
    Senior Directors of Discovery
  • Directors /
    Senior Directors of Development
  • Directors /
    Senior Directors of Commercialization
  • Document
  • Training
  • Consultants
  • Data Managers
  • Safety Managers


Day 1

Day 1 Schedule

Lecture 1:

Introduction / Background

  • Introductions /
    Participants' Understanding
  • Participants'
    Objectives for the Course (Please come prepared to discuss)

Lecture 2:

Data Integrity

  • What is Data
  • How is it
  • Data Integrity
    Frequently Asked Questions

Lecture 3:

21 CFR 11 & Annex 11

  • 21 CFR 11
  • Annex 11
  • 21 CFR 11.10(a)
    - Computer Systems Validation

Lecture 4:

Risk Assessment & Requirements

  • Risk Assessment
    for Requirements
  • Gathering
  • Entity
    Relationship Diagram
  • Process
  • Exercise on how
    to create Requirements
  • SOPs

Day 2 Schedule

Lecture 1:


  • Design
  • Software
    Configuration and Build
  • Exercise on how
    to create Design Specifications

Lecture 2:

Verification & Testing

  • Traceability
  • Verification
    and Testing
  • Other Documents

Lecture 3:

Special Topics

  • Test Tools for
  • Infrastructure

Lecture 4:

Change Control & SOPs

  • Change Control


Angela Bazigos

CEO, Touchstone Technologies Silicon Valley

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 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 Assurance Computer Validation Initiative Committee), ASQ, DIA and RAPS
and consults to investment groups on Lifesciences investments as well as Pharma
/ Biotech / Medical Device companies 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 both to investor groups and industry.

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 on the board for UC Berkeley's Business
School for Executive Education in Life Sciences and on the Stanford Who's Who
Registry for contributions to the Lifescience industry.

Location: Zurich, Switzerland Date:April 19th & 20th, 2017 and
Time: 9:00
AM to 6:00 PM


Venue: Hilton Zurich Airport

Address: Hohenbuhlstrasse 10, 8152 Opfikon-Glattbrugg, Switzerland. +41
44 828 50 50




Price: $1,695.00 (Seminar Fee for One


Register for 5 attendees
Price: $5085.00 $8,475.00 You Save: $3390.00 (40%)*


Until March 10, Early Bird Price:
$1,695.00 From March 11 to April 17, Regular Price: $1,895.00



NetZealous DBA as GlobalCompliancePanel


Phone: 1-800-447-9407

Fax: 302-288-6884



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