Ensuring Integrity and Security of Laboratory Data 2011

Key Topics

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

Who should Attend

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