Ensuring Integrity and Security of Laboratory Data 2018 is an event dedicated to fDA/EU requirements for integrity and security of laboratory data and offer recommendations and tools for implementation.
Ensuring Integrity and Security of Laboratory Data 2018 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 2018 intended for:
- Pharmaceutical and Device Manufacturers
- All 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
- Consultants
