Identify and Manage Data Integrity Issues, CSV and 21 CFR Part 11

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The FDA and other Health Authorities worldwide have focused their attention on data integrity, considering data integrity to be a significant risk to public safety. This is evident in the number of Warning Letter observations and related Import Alerts issued in the last 5-7 years. Data integrity is not a new topic, however, but is a part of the GMPs. Often, companies attempt to address data integrity issues procedurally and by conducting numerous training programs. These tend to be ineffective as data integrity issues are often rooted in a company's culture and may be very difficult to address.

Topics covered in this seminar include the concepts of data integrity Part 11 compliance, risk management, and quality management systems. Through an extensive case study, attendees will work through cultural challenges that contribute to data integrity issues and make change difficult. Many of the examples provided during the seminar will come from the instructor's experience finding data integrity issues during routine supplier audits, and Warning Letter remediation activities that involved data integrity observations. This includes how to conduct a data integrity investigation and targeting the right group for training / discipline.

Learning Objectives:

  • Understanding what data integrity is
  • Why data integrity is a focus by Health Authorities
  • Understand that data integrity is not now - the concepts behind 21CFR Part 11
  • Establish the relationship between company culture and data integrity
  • Understand how data integrity relates to computerized system implementation and usage
  • Applicability of data integrity to legacy systems
  • Relationship between print outs and meta data
  • How to conduct a data integrity risk assessment
  • How to audit for data integrity issues
  • How to mitigate data integrity risk
  • How to remediate data integrity issues

Areas Covered :

  • Regulatory basis for data integrity enforcement
  • Cultural basis for data integrity issues and difficulty to effect culture change
  • Assessing data integrity risk and mitigation
  • How to audit for data integrity issues
  • How to remediate
DAY 01(8:30 AM - 4:30 PM)
  • 8:30-8:59 Registration Meet & Greet.
  • 9:00 AM -10:00 AM: Session 1 – Introduction Session objectives – introduce the topic, regulatory and safety basis, discuss Data Integrity issues observed personally and cited by FDA
    • Warning Letter history
    • Audit examples
    • Why Data Integrity is important to Health Authorities
    • Why Data Integrity is a challenge for industry
    • Where’s the risk?
  • 10:00 AM -11:00 AM: Session 2 – Regulatory Basis Session objective – establish regulatory basis for Data Integrity compliance
    • 21 CFR Part 11
    • Guidance documents
    • MHRA, EU, ICH, PIC/s, WHO
  • 11:00 AM-11:30Exercise – Hydraulic fluid, responsibility, and root cause
  • 11:30 AM-12:00 Noon Session 3 – Challenges Session objective – understand some of the challenges associated with legacy systems and Data Integrity
    • Predicate rule
    • Typewriter rule
    • Printouts and meta data
    • Challenges
      • Older software
      • Periodic software updates
      • Malware
  • 12:00 Noon - 1:00 PM: Lunch
  • 1:00 PM-1:30 PM: Case Study – Part 1
  • 1:30 PM-2:30 PM: Session 4 – ALCOA and ALCOA+ Session objectives – understand how the acronyms form the basis of Data Integrity
    • What is ALCOA and ALCOA+?
    • Examples
    • Building data integrity into your quality management system
  • 2:30 PM-3:00 PM: Case Study – Part 2
  • 3:00 PM-3:30 PM: Break
  • 3:30 PM-4:00 PM: Case Study – Part 3
  • 4:00 PM-4:30 PM: Session 5 – Corporate Culture Session objectives – understand how corporate culture affects compliance and remediation
    • Examples
    • Training focused on shop floor staff and bench chemists, not middle management
DAY 02(8:30 AM - 4:30 PM)
  • 8:30-8:59 Registration Meet & Greet.
  • 9:00 AM-10:30 AM: Session 6 – Best Practices - How to Identify, Assess, Mitigate, and Document Data Integrity Risk Management Session objectives – Identify actions to be taken to proactively identify and reduce Data Integrity compliance risk
    • Build flow charts
    • Process flow chart
    • Data flow chart
      • Identify / analyze risk / prioritize risk
      • Identify risk mitigation strategies
  • 10:30 AM-11:00 AM: Case Study – Part 4
  • 11:00 AM-12:00 Noon: Session 7 – Data Integrity and Computer System Validation Session objectives – Testing of software claiming to be compliant is essential to identify potential data integrity risk
    • The Part 11 compliance package might not be Part 11 compliant out of the box
    • Building the right test cases
  • 12:00 Noon-1:00 PM: Lunch
  • 1:00 PM-1:30 PM: Case Study – Part 5
  • 1:30 PM-2:00 PM: Session 8 - Data Integrity Audit Techniques Session objectives – Learn basic Data Integrity audit techniques
    • General Data Integrity audit techniques
    • Computerize system audit techniques
  • 2:00 PM-3:00 PM: Exercise – Data Integrity audit techniques
  • 3:00 PM-3:30 PM: Break
  • 3:30 PM-4:30 PM: Session 9 – Inspection Readiness and Remediation of Data Integrity Issues Session objectives – understand how to prepare for an inspection and how to mitigate Data Integrity issues
    • Examples of data integrity issues from Warning Letters and remediation actions
    • “In the hot seat” How to prepare for and respond to data integrity investigations
Seminar (Price/Register)
Seminar Fee Includes:
AM-PM Tea/Coffee
Seminar Material
Attendance Certificate
$100 Gift Cert for next seminar

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Speaker: George Bernstein, Principal, Double Dragon Consulting, Inc.

George Bernstein, Ph.D., is a Principal with Double Dragon Consulting, Inc., a consulting firm with a network of Subject Matter Experts located in the US, Europe, and Asia Pacific (China, India). Dr. Bernstein has a Ph.D. in Chemical Engineering and over 30 years of experience in pharmaceutical manufacturing, laboratory operations, data integrity, effective training, and quality risk management. Since 1988, Dr. Bernstein has consulted internationally with major pharmaceutical companies. He has lectured on quality systems and root cause analysis to industry trade groups, quality organizations, and at Interphex. In 1998, Dr. Bernstein led the development, validation, and implementation of an electronic batch record system for a client. This system is still in use today.

Dr. Bernstein’s experience, insights, and innovative problem solving have been integral to his work which ranges from GMP compliance, facility design, construction, and commissioning to business process re-engineering and process optimization. He has developed global quality standards (GLP, GCP, GPP) for a major international pharmaceutical company, and has assisted many clients with audit preparation, remediation activities, and communications with the US FDA.

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