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.
