Laboratory Controls-Chemistry


Virtual Learning
March 11 – 14, 2024

16 hrs VILT, 4 hrs self-paced

4 days


About This Course

Laboratory controls are critical to the decision making of the Quality Unit as they form a critical part of the data to help with batch release decisions.

This highly interactive course, laboratory controls-chemistry is part of NSF’s training program for the Certificate in Pharmaceutical Quality, linked to the US FDA’s 6 systems approach.

Our virtual instructor-led training will be delivered via a combination of live instructor-led virtual classrooms and self-paced online learning. Full details will be sent following registration.

Key Learning Objectives

On completion of this course, you will know and understand:

  • The essential components of a laboratory management system that can ensure data integrity.
  • The basis and limitations for commonly used analytical techniques.
  • The interpretation of data including out of specification and out of trend results.
  • Stability testing requirements.

Course Outline

Laboratory Management Systems

  • Good Control Laboratory Practice
  • Handling out-of-specification (OOS)/out-of-trend (OOT) results
  • Stability testing protocols and methods

Analytical Techniques

  • “Classical”’ methods of analysis
  • Physico-chemical testing of solid dosage forms
    • Hardness, friability, dissolution
  • Spectrophotometric methods
    • Infrared, ultraviolet and atomic spectroscopy
  • Chromatographic methods
    • High performance liquid chromatography (HPLC), gas chromatography (GC), size exclusion chromatography (SEC), thin layer chromatography (TLC), capillary electrophoresis (CE)
  • Proof of structure methods
    • Mass spectrometry (MS), nuclear magnetic resonance (NMR)
  • Biological assays
    • ELISA, PCE and SDS Page

Who Should Attend

Pharmaceutical Quality Unit and Technical Professionals

  • Quality professionals starting in their Quality Assurance or Quality Control roles who want to increase their broad understanding of laboratory controls.
  • Staff whose role requires them to understand laboratory processes such as auditors, those with quality oversight responsibilities and regulators.
  • Many industry professionals from a range of disciplines attend the courses as part of their continuing professional development.

Course Tutors

Course tutors will be selected from the following:

  • Elaine Vandenberg
  • Matt Kruschlich
  • Dave Waddington