Ensuring Integrity and Security of Laboratory Data 2011 is a webinar that covers topics such as:
- 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
Ensuring Integrity and Security of Laboratory Data brings together 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.
