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.

Seminar Fee Includes:
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

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

Who will Benefit:

This Data Integrity Training course is intended for Life Science companies such as pharmaceutical manufacturers (both drug substance and drug product), medical device manufacturers, and those companies conducting or sponsoring clinical trials. In addition to these regulated companies, this course will be of value to those responsible for data integrity compliance.

  • QA/ QC managers and supervisors
  • IT Managers and System Administrators
  • Project Managers and Supervisors
  • Manufacturing Managers and Supervisors
  • Software developers, vendors, and suppliers
  • Regulatory Affairs
  • Training departments
  • Consultants
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
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
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
George Bernstein

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.

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

Register Now

Online using Credit card

Get the Invitation
Pre-Register yourself and get the official Invite when venue and dates are announced for this seminar.
Call here to register +1-888-717-2436 or email at [email protected]

Other Registration Option

By order form / PO#

Payment Mode

By Check -
Pay your check to (payee name) “MetricStream Inc” our parent company and Mail the check to:

ComplianceOnline (MetricStream, Inc),
6201 America Center Drive Suite 240
San Jose, CA 95002

By Wire -

Register / Pay by Wire Transfer

Please contact us at +1-888-717-2436 to get details of wire transfer option.

Terms & Conditions to Register for the Seminar/Conference/Event

Your registration for the seminar is subject to following terms and conditions. If you need any clarification before registering for this seminar please call us @ +1-888-717-2436 or email us @ [email protected]

Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).

Cancellations and substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund - less a $300 administration fee. No cancellations will be accepted - nor refunds issued - within 10 calendar days before the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future ComplianceOnline event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.

In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Attendance confirmation and documents to carry to the seminar venue:
After we receive the payment from the registered attendee, an electronic event pass will be sent to the email address associated with the registrant 5 working days before the seminar date. Please bring the pass to the venue of the event.

Conference photograph / video:
By registering and attending ComplianceOnline conference, you agree to have your photographs or videos taken at the conference venue and you do not have any objections to ComplianceOnline using these photos and videos for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline from any kind of claims arising out of copyright or privacy violations.

We are pleased to offer several exhibitor, sponsorship and media partnership options designed to maximize your company's exposure and networking opportunities before, during and after the event.

Benefits of becoming a Sponsor/Exhibitor/Media Partner:

  • Logo on website, marketing email, branding materials & the registration booth
  • Exhibit Space
  • Free event pass
  • Speaking opportunity
  • Social media campaign

For more details and other sponsorship options at this event, please contact Event Manager: [email protected] or call: +1-650-238-9656

Media Partner:

Media Partner

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

Local Attractions of San Diego, CA

San Diego Cabrillo National Monument

San Diego Cabrillo National Monument

Board a luxurious Think Escape party bus or limo and be whisked away to San Francisco's hottest nightclubs where VIP treatment brings all party bus guests to the front of the line. Board a luxurious Think Escape party bus or limo and be whisked away to San Francisco's hottest nightclubs where VIP treatment brings all party bus guests to the front of the line. Board a luxurious Think Escape party bus or limo and be whisked away to San Francisco's hottest nightclubs where VIP treatment brings all party bus guests to the front of the line.

Sea Creatures at Birch Aquarium

Sea Creatures at Birch Aquarium

Birch Aquarium is north of San Diego in La Jolla. It's not as big as some of the other aquariums in California or as flashy as the big sea-themed park down the road, but instead just right, filled with interesting exhibits and home to leafy sea dragons like the one above, creatures so improbably they look more like something from a children's book than from the ocean.



Legoland theme park takes its inspiration from Lego toys, those cute little bricks that snap together to build all kinds of fun things. It's one of several Legolands worldwide.

San Diego Zoo Safari Park

San Diego Zoo Safari Park

The San Diego Zoo's sister park offers a different kind of animal experience. Its name (Safari Park) is the clue and it indeed offers a more safari-like experience. Lots of large animals live in the same big, open areas here - predators kept away from prey, but otherwise much as they would in their natural habitat.

Coronado Island

Coronado Island

Coronado isn't really an island but a peninsula - a fact that doesn't get in the way of the name most people use for it. Whatever you call it, it's on a slender strip of land between the San Diego Bay and the Pacific Ocean, barely a few blocks wide. What it lacks in size it makes up for in fun, with a beach that's been named among the best in the country, a classic hotel and a compact, lively little downtown. Coronado's laid-back temperament makes a nice break from the busier parts of San Diego across the water.

Balboa Park

Balboa Park

Originally built for temporary use during the 1915-16 Panama-California Exposition in San Diego, Balboa Park boasts buildings beautiful enough to be considered attractions in themselves, especially if you're a photographer. They're surrounded by trees, lawns and fountains, but that's only the beginning.

Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

We need below information to serve you better



6201 America Center Drive Suite 240, San Jose, CA 95002, USA

Follow Us

facebook twitter linkedin youtube


Copyright © 2023 MetricStream
Our Policies: Terms of use | Privacy

PAYMENT METHOD: 100% Secure Transaction

payment method