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Data Integrity courses

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

Courses

  • Sampling and Sample Preparation
  • Basic Laboratory Skills
  • Technical Report Writing
  • Pharmaceutical Dissolution Testing
  • Data Integrity
  • Chromatography
  • Spectroscopy

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Mark Powell Scientific Limited, 17 Blackeys Lane, Neston, Cheshire, CH64 9XA
Tel: + 44 (0)151 353 0995, Mobile: +44 (0) 7860 773572

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