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Ensuring Integrity and Security of Electronic Records for FDA Compliance

Training Options

  •   Duration: 75 Minutes  
  • Recorded Access recorded version only for one participant; unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
    Price: US$275.00
  • Refund Policy


FDA has found and reported about multiple cases where companies manipulated electronic records to bring out-of-specification results into specifications. Since then FDA inspectors have focused during GLP, GCP and GMP 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. This seminar will give a good understanding of FDA requirements and provide recommendations and tools for effective implementation.

Reference material for easy implementation:
  • SOP: SOP: Integrity and Security of Electronic Records
  • SOP: Electronic Audit Trail - Specification, Implementation, Validation
  • SOP: Review of Electronic Audit Trail
  • Checklist: Security and Integrity of Electronic Data for Part11/Annex 11 Compliance

Areas Covered in the Session:
  • Eight key FDA/EU requirements for integrity and security of electronic data
  • How FDA inspectors check integrity and security of data
  • Most frequent security and 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 data: from data acquisition through evaluation to archiving
  • Examples how to ensure and document data integrity
  • Documenting changes of 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
  • Going through representative 10 case studies: FDA observations, complete responses to each observation, corrective actions and preventive actions

Who Will Benefit:
  • IT Managers and System Administrators
  • QA Managers and Personnel
  • QC and Lab Managers
  • Regulatory Affairs
  • Training Departments
  • Documentation Department
  • Consultants
Speaker Profile
Ludwig Huber Ph.D., is the director and editor of Labcompliance 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, Informa Healthcare". He has given more than 300 presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. For more information, please visit Dr. Huber’s website

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