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All documents shown here are included in the seminar for instant download

Edwin Rivera
 Data Integrity and Fraud - An Other looming Crisis

Steve Wilson:
FDA Regulatory Perspective on Data integrity

Warning letters and Inspectional observations related to raw data and other electronic records

Labcompliance On-line Audio Seminar

This seminar has been recorded and is available on CD and for instant download. All reference material as listed below and more is available on a special seminar website. The website is regularly updated with most recent information. In case there are questions related to the topic, they can be submitted through a web form and will be answered by the speaker. For ordering info click here
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So far we have received very positive feedback from attendees of Ludwig Huber's seminars on FDA Part 11 inspections, to see the feedback click here.

On-line Audio Seminar 353

Ensuring Data Integrity for FDA/EU Compliance

Comply with FDA Part 11 and EU/PICS Annex 11 for paper, electronic and hybrid records

Recorded, available with all reference material at any time

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FDA has found and reported about multiple cases where companies manipulated electronic records.  Since then FDA inspectors have focused inspections on security, availability, accuracy and integrity of 'complete' records. FDA has trained inspectors to identify data falsification and recommended the same to industry QA departments and auditors. Just in the last three years FDA issued many warning letters and 483 form inspectional observations related to electronic records. The industry is unsure how to comply with FDA inspection requirements. 

Key Questions are:

  • What are FDA requirements and inspection practices for electronic data?
  • What are the most frequently found inspection deviations?
  • Can I delete the electronic records after I have printed and signed the electronic records?
  • FDA requires availability of 'complete' records, what does this mean for laboratory, manufacturing and for the device QSR?
  • How to define raw data?
  • What are the requirements for data integrity and security?
  • How to demonstrate data integrity and security?
  • Is e-audit trail still under enforcement discretion and what does this mean?
  • FDA and the Annex 11 require reviewing electronic audit trails. Who should do this, when and how should it be documented?
  • FDA several times mandated data integrity consultants. What is their duty?
  • How important is risk assessment for managing laboratory data?
  • I scan paper print-outs and store PDF files in a data base - can I delete the paper records?
  • The new EU Annex 11 requires indicating changes of raw data on print-outs, how can we do this?
  • Should I be able to reprocess the reprocess electronic raw data and if so for how long?

How does the this audio seminar help:

Answers will be presented by Dr. Ludwig Huber in a new interactive audio seminar. During the seminar, the speaker will present strategies and give practical recommendations and case studies. After the seminar, an extensive list of reference material like SOPs, worksheets, templates and examples will help immediate and cost effective implementation of the principles and strategies.

During the interactive presentation you learn about:

  • Eight key FDA/EU requirements for integrity and security of electronic records
  • How FDA inspectors check integrity of data
  • Most frequent data integrity issues: going through recent 483's, EIRs and warning letters
  • The importance of limited access to 'individual users' rather than to groups
  • FDA compliant definition, acquisition, maintenance and archiving of raw data
  • Critical integrity and security issues during the entire life of records
  • Examples how to ensure and document data integrity
  • Documenting changes of regulated data: paper, hybrid systems, electronic
  • The importance of electronic audit trail to document data integrity
  • Review of electronic audit trail: who, what, when and how
  • Ensuring timely availability through validated back-up and archiving
  • Required skills and responsibilities of (3rd party) consultants?
  • Going through 10 representative case studies: FDA observations, complete responses to each observation, corrective actions and preventive actions

And for easy and instant implementation:
download 10+ documents from special seminar website

  • SOP: Integrity and Security of Electronic Records
  • SOP: 21 CFR Part 11 - Scope and Controls
  • SOP: Electronic Audit Trail - Specification, Implementation, Validation
  • SOP: Review of Electronic Audit Trail
  • SOP: Responsibilities of internal and 3rd Party Data Integrity Consultants
  • Checklist: Security and Integrity of Electronic Data for Part11/Annex 11 Compliance
  • Checklist: Electronic Audit Trail
  • 10 Case studies: FDA observations, complete responses to each observation, corrective actions and preventive actions
  • FDA Presentation: Data Integrity and Fraud – Another Looming Crisis?
  • FDA Presentation:  Steve Wilson FDA Regulatory Perspective an Data integrity
  • Regulatory reference documents:
    - FDA Drug cGMP: Requirements for 'Complete' Laboratory Records
    - Requirements for Clinical Trial Records
  • Literature Reference papers.
    - Implementing 21 CFR Part 11 - Data Migration and Long Term Archiving for Ready Retrieval
    - Implementing 21 CFR Part 11 - Data Integrity
  • 20+ Warning letters and Inspectional observations related to computer systems and electronic records

The Record Lifecycle

Data integrity must be ensured through the entire record life. Attend the seminar to learn how.

Who should attend?

  • All companies generating electronic records in regulated environments
  • Pharmaceutical and Device Manufacturers
  • API Manufacturers
  • Contract Laboratory Organizations providing services for GxP compliance
  • Documentation professionals
  • QA/QC managers and personnel
  • Analysts and lab managers
  • Validation specialists
  • Regulatory affairs
  • Training departments
  • Consultants

Date, time and duration

Recorded seminar, available at any time with all reference material

How to order

Pick one of the options in the table that fits your needs.

Recorded seminar - Web Download

  • Multiple persons - single site
  • Learn at your desk, meet in a seminar or conference room or share the audio file and reference material at your site.
  • Order includes all reference material.

US$ 399.-
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Recorded seminar - CD

  • Get the CD in your mail
  • Order includes all reference material.

US$ 399.-
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Special offer for Labcompliance Usersclub Members
Recorded Seminar- CD or Web download.

  • Order includes all reference material.
  • for Usersclub information and registration, click here

US$ 299.-
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vAbout audio seminars

Online audio seminars are presented over the phone. During the live presentation attendees can:

  1. Study the printed slide material
  2. Watch the slides on a computer
  3. Watch the slides on a video screen in a seminar room
  4. Ask questions through email and web form

About Dr. Ludwig Huber

Dr. Ludwig Huber is the editor and author of Labcompliance. He has been conducting over 300 web and audio or video based seminars since 15 years and and he has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This included seminars, workshops and presentations for the US FDA, SFDA, KFDA, HSA, ISPE, PDA, PIC/S and several national health agencies.

Dr. Ludwig Huber is a frequent presenter at IVT conferences and has been awarded as the 'Presenter of the Year' out of 170 speakers. This photo is from IVT's conference on Network Qualification with Ludwig Huber as plenary speaker.

Dr. Huber has published several books related to validation and compliance, for example: Validation of Computerized Analytical and Networked Systems. He was or still is a member of several committees, e.g., of the GAMP® Special interest group (SIG) on Laboratory Computers, PDA Part 11 task force, IVT task force on network infrastructure qualification and the European Compliance Academy. He frequently visited FDA in Rockville, VA, and participated in panel discussions with FDA professionals. For feedback from attendees of seminars and  for other information on Dr. Ludwig Huber, click here.

Dr. Ludwig Huber in Panel Discussions with FDA Officials

George Smith, FDA's national Part11 expert, at a panel discussion with Ludwig Huber during an IVT conference

Smith and Huber discussed and answered questions about computer system validation and e-records.
Ludwig Huber (right) and John Murray, FDA's Computer Validation Expert, (left), speaking at the IVT Computer System Validation Conference.
Mr. Murray explined FDA'snext steps for Part 11

Ludwig Huber (right) in a panel discussion with FDA inspectors and directors:
 Dr. Robert C. Horan, B Erik Henrikson,Joseph Famulare,  and Nicholas Buhay,




The Feedbacks on the seminar has been received by e-mails. Labcompliance has permission to use the testimonials as references. Original e-mails are stored in the Labcompliance archive.

  1. Seminar: Understanding and Preparing for FDA's New Part 11 Inspection Program
    Feedback: The seminar did exceed my expectations.  The seminar is very useful as it contains a lot of information.
    Mr. Lucian Hirtie,  QS Manager, Labstat International ULC, Canada
    (Ref T-1082).
  2. Seminar: Ensuring Integrity and Security of Electronic Records for FDA Compliance
    Feedback: The seminar did exceed my expectations.  The information is very complete. Dr Huber knows the subject very well. Excellent presentation
    Mr. Han Seng Tay Manager GGB,  Health Sciences Authority, Singapore, USA
    (Ref T-1
  3. Seminar: Understanding and Preparing for FDA's New Part 11 Inspection Program
    Feedback: The seminar did exceed my expectations.  Very informative presentation, and clearly presented . Dr Huber does an excellent presentation, well developed, and very informative, as usual.
    Mr. John Egoville,  Senior Compliance Auditor,  Computer Validation Group, TEVA Pharmaceuticals, USA
    (Ref T-1081)

  4. Seminar: Recent Warning Letters and 483's Related to Computer Validation and Part 11
    The seminar did exceed my expectations.  The presentation contains much more pertinent information than I had expected.
    Mr. Joachim Fehr, Stryker, CSV Specialist QA, Germany
    (Ref T-1076).
  5. Seminar: FDA's New Enforcement of 21 CFR Part 11
    The seminar did meet my expectations.  I always expect a wonderful seminar from Dr. Huber, and my expectations were once again met. A great time saver for me as I do not have time to look up recent 483s relating to Part 11 -- worth the time and cost.
    Ms. Diana Mayes, Manager of ABC Laboratories, USA
    (Ref T-1077)
  6. Seminar: FDA's New Enforcement of 21 CFR Part 11
    The seminar exceed my expectations.  Webinar was very informative to our current practice and will help us focus and stream line our process. I would recommend this seminar to everyone having the same responsibilities.
    Ms. Mike Robertson, QA Engineer at Energizer, USA
    (Ref T-1078).