2 Days seminar Assuring Data Integrity in the Life Science industry

By: Chinmoy Roy, BSEE, MSCS US FDA Expert Data integrity & CSV.
Product code: SEM60
Location 1: San Diego CA Aug 07 - 08


Course “Assuring Data Integrity in the Life Science industry" has been Pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

"Each attendee will receive 2-Day workshop materials by the speaker. Seminar Also Includes Certificate, Complimentary Breakfast, Lunch & High Tea/Coffee provided by WCS"

Due to increased regulatory focus on data integrity, biopharmaceutical companies are making a beeline to attend mushrooming training workshops and seminars on data integrity. These companies are also inviting third party auditors to their facilities to audit for data integrity. Several technical publications are devoting significant space in their journals to highlight the problem of data integrity. Glaringly absent from all these are specifics of a holistic approach to a solution for these data integrity problems. 
Our clients approached us with a request to design a data integrity training program that address the “how to” of data integrity and not the “what” like existing programs do. Consequently, we set out to offer a solution-based training program instead of audit-based program offerings that is prevalent in the industry.
Our trainer, award-winning FDA data integrity compliance expert Chinmoy Roy, was a principal design architect of the world’s largest biologics manufacturing facility. This paperless manufacturing facility still continues to be the world’s “gold standard” for data integrity, complete with a web of data integrity policies, directives and SOPs.  He is bringing his expertise to this workshop to address the specifics of a data integrity management infrastructure.  
The training will kick off with a compendial treatment of Data Integrity fundamentals. After laying the groundwork, the workshop will transition to a format to include interactive group discussions and lectures.  These will be directed towards developing and establishing an acceptable and effective Data Integrity infrastructure. Addressed will be development of a Data Integrity Policy, contents of Data Governance directives documents such as Code of Conduct, Roles and Responsibilities etc.  Also addressed will be specifics of SOPs related to Data Management such as Audit Trail review SOP, Data Backup, Archive and Restore, Business Continuity, Disaster Recovery etc. Besides the specifics of Data Integrity SOPs and directives, attending the workshop will also provide answers to questions such as:

•       What Data integrity really means
•       How to navigate the maze of Data Integrity Guidances
•       How to conduct a Data Integrity Risk Assessment
•       Data Integrity challenges in use of Cloud services
•       And much, much more…

Chinmoy Roy is one of the world’s first to direct a team of engineers, IT, and QA teams in the design, implementation and obtaining “fit for use” certification for the world’s largest paperless biologics manufacturing facility. He is a practicing Data Integrity auditor. Former FDA inspectors include him on their 3rd party and mock audit teams. He also continues to provide consulting services in the design and implementation of Data Integrity infrastructures to major multinational companies. His presentations on Data Integrity at worldwide conferences earned him the prestigious award of “Speaker of the Year” by conference attendees at a leading US conference.
Plan on attending the training and also take the opportunity to network and participate in interactive discussions with fellow attendees from the biopharmaceutical companies

Areas Covered

•      Data and Data Integrity: concepts, meaning of integrity, data dimensions
•      Primer on 21 CFR Part 11 and Annex 11
•      Data Governance 
•      Data Management
•      Data Integrity in IT, Manufacturing, Laboratory systems
•      Overcoming Data Integrity challenges with Cloud services
•      Data Integrity auditing techniques for Internal Audits

Who will 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, Manufacturing Automation system vendors and system integrators
•       Regulatory Affairs group, Quality Unit
•       Laboratory personnel
•       Users of Cloud
•       Clinical Trial Sponsors

Learning Objectives

Some advanced Data Integrity topics include:

•      Data Integrity triad
•      Data Integrity Maturity Model
•      Developing critical thinking skills
•      Data Integrity challenges with Cloud services
•      Cybersecurity in the Cloud
•      Data Integrity Audit trends

Course Outline:

8:30 AM – 4:30 PM

Module 1

•       Data and Data Integrity: concepts, meaning of integrity, data dimensions
•       Practically speaking, what is data, raw data, metadata
•       What are the principles of Data Integrity
•       Data Integrity attributes with examples
•       Different data types: aberrant data, orphan data, incomplete data etc.

Module 2

Primer on 21 CFR Part 11
•       21 CFR Part 11 (P11) and Annex 11 (A11) fundamental concepts
•       P11 Scope and Application guide
•       Why is Data integrity not the same as x11 (P11 and A11)
•       Discuss USFDA Data Integrity Guidance of December 2018

Module 3

Data Governance
•      Data Integrity Governance documents and their contents
•      Data Integrity impacts due to organizational and individual behavior
•      How to overcome human factors challenges to ensuring Data Integrity
•      Major differences in USFDA’s DI initial and final guidance; their changing               thinking

Module 4

Data Management Good Practices
•       Data Integrity Maturity Model
•       Data Life Cycle
•       Audit Trail review
•       Data Backup and Recovery
•       Validation of Computerized Systems


8:30 AM – 4:30 PM

Module 5

Data Integrity in IT, Manufacturing, Laboratory systems
•      How IT system architecture impacts Data Integrity
•      IT configurations of Active Directory, Group policy etc. to attain Data Integrity
•      DI risk assessment and how is it different from regular FMEA risk                           assessments

Module 6

Overcoming Data Integrity challenges with Cloud services
•      Cloud types and cloud service models
•      Data Integrity issues with different types and service models
•      How do you validate Data Integrity issues for cloud use
•      What SOPs are required to demonstrate how your company is addressing              those issues
•      Addressing Cybersecurity in the Cloud

Module 7

Data Integrity auditing techniques for Internal Audits
•      Developing a Data Integrity audit checklist
•      Critical thinking skills for Internal Auditors
•      How can you effectively use your Data Integrity Maturity Model during audits
•      FDA’s new approaches to data integrity audits 

Module 8

Data Integrity Case Studies 
•      Implementing Data Integrity compliance for existing manufacturing line and           laboratory
•      Real World case studies – an interactive discussion



Chinmoy RoyBSEE, MSCS US FDA Expert Data integrity & CSV

Subject Matter Expert: Data Integrity, GAMP, CSV, CFR 21 Part 11, Annex 11, Quality Risk Management, Manufacturing Process Automation and IT systems

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.

07-August-2019 To 08-August-2019 San Diego CA
Seminar One Registration
$ 1295

Special Group Discount Register for Four attendees
$ 3995

Please call any of our customer support on 844-267-7299 to avail the below discount for your Group

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3 to 6 Attendees - 10% off

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Homewood Suites by Hilton San Diego-Del

Mar Phone: +1 858-720-9500

11025 Vista Sorrento Parkway

San Diego, CA 92130, CA 92130

United States

How to Reach


I have attended various seminars from WCS but this "Live" one was incredible. This seminar was excellent.

Pfizer Quality Manager

I liked WCS training style. WCS speakers gave excellent examples to back up what speaker was explaining. Which helped me grasp a better understanding."

RA/QA Manager Abbott

The presenter was excellent session leader, very knowledgeable and well-spoken. The topic was well chosen and interaction between the participants and the presenter was good.

Chief Compliance Officer

This was an informative seminar. Provided very valuable insight into how the FDA works. Presenters' experience in real life events and interaction with the FDA is priceless.

Quality Assurance Medtronic

“I enjoyed the training, the instructor was engaging and were able to modify the course to make it more applicable for small group.”

Peter Belsito, Director of Quality TSI

Awesome material covered.  Andbero Magleo, IT Admin Passy-Muir

“Very informative with enough details to start putting together action plans. Susan Murphy, Associate Director, Quality investigation (QA) LFB USA

“I learned a lot from the instructor and trainee good.” David QU, senior Analytical Chemist Dalton Pharma Services.


“Well placed, a lot of good information. Good interaction between participants. Held at a good location. More was US based examples given.” Nicola Mootoo, Senior Validation Engineer Shire Pharmaceuticals


“Well delivered seminars, right place, good contents.” Evelyn Chang, Corporate manager Genzyme.

“I though the contents of the presentation and the discussion was very good.”Mary Beird, Regulatory Compliance Manager Charles River laboratories International, Inc.


“Great session. I learned a lot” Chief HR Professional"

“Wow!  I had an opportunity to attend the HR audit workshop.  It is spectacular and I found it very valuable.
It will help us audit and manage strategic HR issues.” The president of a major insurance and risk management agency.

“I found the audit session very useful; it will help us identify and manage key HR management issues.” A senior auditor

“The session provided important information about HR auditing. It will help us audit critical HR issues and outcomes
 and will help us assess the organization’s culture and values.” A Chief Internal Auditor

“I’ve been doing a lot of research lately on HR audits, trying to find the best system for us.
This session and ELLA seems to really fit the bill for us.” A human resource manager


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15-20 minutes product demo during the live session

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