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Seminar on FDA Data Integrity for Computerized Systems in Mumbai

Thursday, Apr 27, 2017 at 9:00AM - Friday, Apr 28, 2017 at 6:00PM

The LaLiT Mumbai

  • Apr 2017

    27 Thu


  • Apr 2017

    28 Fri


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Seminar on FDA Data Integrity for Computerized Systems in Mumbai

Thursday, Apr 27, 2017 at 9:00AM - Friday, Apr 28, 2017 at 6:00PM


No tickets available


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 skyrocketing!

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 Compliance?
  3. Data Integrity Frequently Asked Questions
  4. Validation Master Plan
  5. Risk Based Assessment
  6. Complete Validation for a System (software development
  7. Automated Test Tools
  8. Infrastructure Requirements
  9. Change Control
  10. SOPs

Who will benefit:

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


Day 1 Schedule

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 Integrity
  • How is it implemented
  • 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
  • Gathering Requirements
  • Entity Relationship
  • Process Decomposition
  • Exercise on how to create
  • SOPs

Day 2 Schedule

Lecture 1:


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

Lecture 2:

Verification & Testing

  • Traceability Matrix
  • Verification and Testing
  • Other Documents

Lecture 3:

Special Topics

  • Test Tools for DATA
  • 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

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: Mumbai, India Date:April 27th
& 28th, 2017 and Time: 9:00 AM to 6:00 PM

Venue: The LaLiT

Address: Sahar Airport
Road, Andheri East, Mumbai - 400059


Register now and save ₹ 2000. (Early Bird)

Price: ₹ 14,000 (Seminar for one Delegate)

Until March 25, Early Bird
Price: 14,000 From March 26 to April 25, Regular Price: 16,000


- GlobalCompliancePanel

NetZealous Services India Pvt. Ltd.
Gururaya Mansion, 759 to 764, 8th Main road, J.P.Nagar, 
Bangalore - 560078 Karnataka, INDIA

Phone:  1800 425 9409 

Fax:  080-25149544

Link –

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