In light of the pandemic situation events until September 2021 are cancelled. We will inform customers directly when the events are rescheduled.    
COVID CANCELLED: Project Management in Human Resources,   Boston MA, Jan 6-8, 2021
COVID CANCELLED: InterDrone, The International Drone Conference,   Cambridge MA, Jan 11-13, 2021
COVID CANCELLED: Supplier Management for Medical Device Manufacturers,   Cambridge MA, Feb 2-4, 2021
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Following events are tentatively planned but may be rescheduled, based on CDC guidelines or attendee registration interest .    
TENTATIVE: 21 CFR Part 11 Compliance,   Boston MA, Sep 22-24, 2021
TENTATIVE: Quality Control Laboratory Compliance,   Boston MA, Oct 6-8, 2021
TENTATIVE: Analytical Instrument Qualification and System Validation,   Boston MA, Nov 15-17, 2021
TENTATIVE: FDA's New Import Program for 2021,   Boston MA, Dec 7-9, 2021

Boston Professional Events List

Current issues in assuring data integrity in life sciences : 2 Days Seminar

Nov 16, 2021 - 08:00 AM
conference Manager
San Diego CA
WCS Consulting Inc.3190 Stirling Rd, Unit K4, Hollywood, FL 33021,

Washington D.C,
ZIP: 20002
Phone: 347 282-5400

Ticket Price: Seminar One Registration - $1,295.00 Special Group Discount Register for Four attendees - $ 4995
Data Integrity is a major concern of regulatory agencies worldwide as evidenced by the increasing number of Warning Letters issued in that area.  Some managements have proceeded to implement data integrity programs on the lines of those implemented in “big data”.  This has resulted in the escalation of costs and it is disproportionate to the benefits gained.  Some even wonder why they continue to receive Warning Letters in spite of spending the dollars to implement programs such as Data Governance etc. etc.

Areas Covered

What is Data integrity

Data Life Cycle design and controls

Elements of a Data Integrity Assurance program

Roles and responsibilities of different groups in ensuring data integrity

What data integrity SOPs do auditors expect to see during audits

Validating Data Integrity


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 Audit trends 



Course Outline:

DAY ONE (08:30 AM to 05:00 PM)


Module 1

Data and Data Integrity: concepts, meaning of integrity, data dimensions

   • Practically speaking, what is data, raw data, metadata

   • Meaning and principles of DI

   • Data types and their relevance to DI

   • DI dimensions with examples of 483 and Warning letters

   • Why is DI not considered to be a new requirement


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)


Breakout group exercise: Mapping DI to Part 11


Module 3

Data Integrity Guidance from USFDA/MHRA/EMA/WHO/PCS 

   • What are similarities and differences between the guidance


Module 4: 

"Implementing a DI assurance plan using the “Least burdensome approac”

   • PQLI and its relevance to Data Integrity

   • What is the “Least Burdensome Approach”

   • Why DI issues occur and how to avoid them proactively

   • DI implementation plan: the 5p model and the Controls Triad

   • What DI SOPs do auditors want to see and what should their contents be



DAY TWO (08:30 AM to 04:30 PM)


Module 5:

Data Integrity in IT and Manufacturing IT systems

    • Data Integrity impact due to the architecture of IT system

    • Implementing Active Directory service, Group policy etc. to attain DI

    • DI susceptibilities of hybrid systems commonly found in manufacturing IT systems  

   • DI risks when generating electronic records which are true copies of paper records

   • What data integrity items to review for during a Electronic Batch review


Module 6

Data Integrity in the Laboratory

    • Why is laboratory Data Integrity the key focus of all regulatory audits

    • Laboratory Data Integrity audit trend and what is needed to avoid citations

   • Conducting DI risk assessment, trainee participation required 

   • Core documentation that you must have to demonstrate laboratory Data Integrity

   • What should be the contents of the documents

   • What is the role of the laboratory manager in fulfilling DI


Breakout group exercise: Develop an Audit Trail review SOP


Module 7

Data Integrity considerations in Clinical Trial Systems (CTS)

     • Mobile computing issues

     • Latest US FDA’s Part 11 guidance for CTS

     • US FDA’s latest Cybersecurity guidance for CTS


Module 8

How is Data Integrity audited

    • 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 


Speaker Details

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.

Event Categories
Keywords: Educational, data , seminar


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