Data Integrity courses

data-integrity

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