Computer Systems Validation (CSV) and Data Integrity


This interactive 2-day conference and workshop is for novices, advanced users, senior management and others who use computer systems for laboratories, clinical trials, manufacturing, quality and validation. This unique conference explores the latest industry standards such as GAMP V for validating data integrity, data access security, data transfer, data migration and audit trails. Addressed will be the development of dynamic programs designed to deliver useful strategies for assuring consistent quality and preventing regulatory intervention.

Why should you attend this seminar?

The conference will offer unique opportunities not found at other events, including lessons from companies that have demonstrated successful turnaround of complex regulatory situations such as inadequate validation, data integrity violations etc. Past 483s and Warning Letters will be used to devise a Data Integrity Assurance Plan using "the least burdensome approach.". Also addressed will be directives and SOPs that are required to address auditors' concerns with data integrity etc. Attendees will also gain familiarity with how 21 CFR Part 11 and Annex 11 fits into the CSV process.

Areas Covered in the Session:

  • What are the five pillars required for effective CSV?
  • What CSV deliverables regulators expect and what they should contain
  • What are the different Validation models and how to choose the correct one
  • Primer on 21 CFR Part 11 and Annex 11; similarities and differences
  • Fundamental data concepts
  • What Data Integrity really means
  • What are the attributes for integrity of data
  • What auditors expect to see in a company's data integrity program
  • What are the success factors in establishing a data integrity program?
  • How to use "the least burdensome approach" to implement a DI program
  • How is Data Integrity audited? 
Who can Benefit:

  • Pharmaceutical industry / Medical device industry / Healthcare industry personnel
  • Developers of software for use in Life Sciences industry
  • Validation service providers, IT service providers
  • Manufacturing personnel, Automation system vendors and system integrators
  • Regulatory Affairs group, Quality Unit


08:30 -   08:45  Introduction
08:45 -   09:30  Fundamental concepts of validation
09:30 -   10:15  The CSV lifecycle models and how to choose one
10:15 -   10:30  BREAK
10:30 -   12:00  What are the CSV deliverables and what they should contain
12:00 -   01:00  LUNCH BREAK
01:00 -   01:45  Workshop, CSV Quiz
01:45 -   02:45  21 CFR Part 11 unplugged
02:45 -   03:00  BREAK
03:00 -   04 :00 Annex 11 and Part 11/Annex 11 differences
04:00 -   04:45  Fundamental data concepts


08:30 -  09:30   Data Integrity ALCOA+ concepts unplugged with 483 and WL examples
09:30 -  10:30   Establishing a Data Integrity program in the company
10:30 -  10:45   BREAK
11:00 -  12:00   What is the -least burdensome approach- I establishing a DI program
12:00 -  01:00   LUNCH BREAK
01:00 -  01:45   Workshop, Part 11/Annex 11 and DI quiz
01:45 -  02:45   How is Data Integrity audited
02:45 -  03:00   BREAK
03:00 -  04:30   General Discussions
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Chinmoy Roy

Chinmoy Roy has 37+ years of experience. He is an internationally recognized subject matter expert in CSV, CFR 21 Part 11, Annex 11, Data Integrity and manufacturing process automation systems. He has been invited to speak and conduct training workshops at several international conferences such as ISPE, WBF, Shimadzu?s annual conference for Asia Pacific, etc.
His expertise stems from his experience in implementing and obtaining ?fit for use? certification for over 200 IT systems. He has worked at and consulted with leading US based companies such as Roche, Genentech, Bayer, Novartis, Johnson and Johnson etc. His pioneering efforts in implementing CFR 21 Part 11 compliant manufacturing IT systems in 1999 while employed by Genentech, was a precursor to FDA?s issuance of Part 11?s Scope and Application guidance in 2003. His workshops are unique in that he blends his field experience to provide case studies to explain the intricacies of implementing regulations. Chinmoy is an Electrical Engineer and a Computer Science post graduate.

Four Points by Sheraton Miami Airport
3570 Nw 74th Ave
Miami FL 33122 United States

If you are in a group of 2-10. Select "Multiple Attendee" and get upto 30% discount.

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South Beach

No visit to Miami can be considered complete without a stop at South Beach -- the quintessential Miami hot spot. From shopping to partying, this area of Miami Beach is well-known for being a trendy locale. Depending on your personal tastes, you might enjoy spending a full weekend touring South Beach.


The Miami Seaquarium is located right in the middle of the tourist area, on the causeway between downtown Miami and Key Biscayne. It's a fabulous stop where you can witness an outdoor aquarium experience that's only possible in our tropical climate. Be sure to budget enough time to spend at least half a day there!

Miami Museum of Science

Check out the latest kid-friendly exhibits at the Miami Museum of Science. You're bound to find a learning adventure for the whole family. The museum is home to the Bird of Prey Research Center and the Weintraub Observatory.If you have kids (or just like to act like them!), the Miami Children's Museumis a must-see destination.


With 1.5 million acres of swamps, saw-grass prairies, and sub-tropical jungles, Everglades National Park is one of the most unusual public parks in the United States. Located on the southern tip of Florida, the park is home to 14 rare and endangered species, including the American Crocodile, the Florida Panther, and the West Indian Manatee.

Seminar Id:IJ2018S3
image  Speaker: Chinmoy Roy
calender   Date: 22-Mar-2018
clock  Start Time: 05:30 AM PT | 08:30 AM ET
map  Place: Miami, Florida USA
Seminar Fee Includes:
lunch Lunch
tea AM-PM Tea/Coffee
Transfer  Shuttle service from airport
Parking  Free Parking
material Seminar Material
hard_copy Hard copy of presentation
certificate Attendance Certificate
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