Data Integrity Awareness for Laboratory Analysts
A half-day course on data integrity for analytical chemists including:
- Pharmaceutical quality: safety and efficacy
- Background to data integrity: fraudulent data case studies
- Consequences of fraud for companies and individuals
- The requirements of data integrity
- Sampling and traceability
- Informal testing (e.g. trial injections)
- Computerised systems – including date stamps, audit trails and user accounts
- Laboratory data systems – data acquisition and processing methods
- Reporting and archiving results
- Practical exercise – identifying potentially fraudulent data
Data Integrity Auditing
A one-day course on data integrity auditing including:
- Introduction and fraudulent data case studies
- Extracts of FDA warning letters relevant to data integrity
- The requirements of data integrity
- Sampling and traceability
- Informal testing (e.g. trial injections)
- Computerised systems – including date stamps, audit trails and user accounts
- Laboratory data systems – data acquisition and processing methods
- Reporting and archiving results
- Practical exercises
- Auditing laboratory records
- Auditing laboratory data systems
- Auditing LIMS systems