Ensuring Data Integrity for FDA/EU Compliance



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 over 30 warning letters and 483 form inspectional observations related to electronic records. The industry is unsure how to comply with FDA inspection requirements. Because of missing clear guidance from the FDA the industry has lots of questions. Using recent warning letters as examples, this seminar will demonstrate how current data integrity requirements will be identified, implemented and documented.

For easy implementation, attendees will receive
SOP: Integrity and Security of Electronic Records
SOP: Review of Electronic Audit Trail
Checklist: Security and Integrity of Electronic Data for Part11/Annex 11 Compliance

Areas to be Covered:

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 of data through validated back-up and archiving
Required skills and responsibilities of internal and 3rd party consultants?
Going through representative case studies: FDA observations, complete responses to each observation, corrective actions and preventive actions

Who will Benefit:

Everybody using computers in FDA regulated environments
IT managers and staff
Manufacturers of drug substances (APIs)
Medical Device Manufacturers
Analytical Contract laboratories
Clinical contract laboratoriers
QA managers and personnel
Quality control directors or delegates
Internal auditors
Regulatory affairs
Training departments
Validation specialists

Dr. Ludwig Huber

Ludwig Huber, Ph.D., is the director of Labcompliance and editor of (www.labcompliance.com), the global online resource for validation and compliance. He is the author of the books “Validation and Qualification in Analytical Laboratories” and “Validation of Computerized Analytical and Networked Systems”. He has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11, 21CFR Part 111 and Validation around the world. This included seminars, workshops and presentations for the US FDA, China SFDA, Korea MFDS, Singapore HSA, ISPE, Japan PDA, PIC/S and several other national health care agencies. For more information, please visit Dr.Huber’s website (www.ludwig-huber.com).


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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance