About This Course

This course provides you with the necessary skills and an understanding of how you can check for evidence of both effective data management and data fraud during chemical quality control (QC) laboratory audits. It also ensures you understand how chemical QC laboratories should manage the generation, analysis, reporting and storage of data.

Regulatory concerns over pharmaceutical data integrity mean that it is essential you conduct effective audits of your QC laboratories. This course covers key elements of the chemical QC laboratory management system that pose the greatest risk to data integrity. Failure to comply with basic Good Manufacturing Practice (GMP) expectations can easily be interpreted as critical data integrity issues by regulatory inspectors, so it is vital that you thoroughly audit your own systems and those of any contractors you employ.

QC laboratories provide the data upon which critical decisions, such as batch release and the stability of product, are based. If the chemical laboratory data is incorrect, then decisions may be wrong with potentially disastrous consequences for companies and patients. Unfortunately, a significant proportion of recent regulatory inspection issues with data integrity were related to data generated by QC laboratories.

Key Learning Objectives

By the end of this auditing QC labs training course you will know and understand:

  • The elements that make up an effective data management system within a chemical QC laboratory
  • How key elements of the QC laboratory data management system contribute to the assurance of data integrity:
    • Documentation (electronic and paper-based)
    • Sampling and sample management
    • Laboratory equipment
    • Analytical methods (validation, verification and transfer)
    • Chromatography and integration
    • Out of specification (OOS) and out of trend (OOT) results
  • How to audit QC laboratories effectively to ensure compliance with data integrity expectations

Course Outline

  • Overview of Good Control Laboratory Practice (GCLP) and the potential for different elements to impact data integrity
  • Planning an audit of a QC laboratory
  • Best practices for laboratory documentation
  • Sampling and management of lab sample
  • Qualification and calibration of laboratory equipment
  • Classifying laboratory audit findings
  • Validation, verification and transfer of analytical methods
  • Chromatography (a risk area for data integrity)
  • Managing OOS & OOT results (investigations and reporting)
  • Preparation of an aide-mémoire to audit a laboratory

Who Would Benefit

This course is ideal for personnel who work in a chemical QC laboratory or who have a quality oversight role and wish to learn how to conduct comprehensive audits of QC chemical laboratories.

Discounts

Early bird and multi-delegate discounts available. Discounts also offered to NHS staff, regulators and charities.

Early bird discounts cannot be used in conjunction with multi-delegate discounts.