Ensuring Integrity and Security of Laboratory Data for FDA / EU Compliance

This webinar will provide a comprehensive understanding of the key FDA/EU requirements for integrity and security of laboratory data and offer recommendations and tools for effective implementation.

The FDA has found and reported multiple cases where companies manipulated electronic laboratory 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’ laboratory records. The FDA has trained inspectors to identify data falsification and recommended the same to industry QA departments and auditors.

In the last three years alone, the 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 webinar will provide a comprehensive understanding of the key FDA/EU requirements for integrity and security of laboratory data and offer recommendations and tools for effective implementation.

For easy implementation, attendees will receive:

• SOP: Integrity and Security of Electronic Laboratory Data.
• Checklist: Security and Integrity of Electronic Data.
• SOP: Electronic Audit Trail – Specification, Implementation, Validation.
• 10 Case studies: FDA observations, complete responses to each observation, corrective actions and preventive actions.

Areas Covered in the Session :

• Eight key FDA/EU requirements for integrity and security of laboratory 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 laboratory data: from  data acquisition through evaluation to archiving.
• Examples how to ensure and document data integrity.
• Documenting changes of laboratory 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 Should Attend:

• All companies generating laboratory 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

Course Director: 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).