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Laboratory Controls-Chemistry

Currently there are no upcoming courses scheduled. Contact us to find out when the next course will run or if you need customized training. We can deliver this course and a broad range of other training topics at your location, off-site or virtually.

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