Laboratory Controls-Chemistry

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.

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.

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

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 will be selected from the following:

• Elaine Vandenberg
• Matt Kruschlich
• Dave Waddington