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

Description

Presenter Details
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 483s, 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 Will Benefit:

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