USP Certificate of Lab Procedures
The USP Certificate of Lab Procedures gives prospects a comprehensive understanding of the USP Standards that are applicable and essential in a laboratory. This certificate is currently composed of Key Analytical Instrumentation lab procedures as well as Fundamental Courses - Uniformity in Dosage Units, USP Requirements for Balances and Good Documentation Practices that reinforce the skills that support good laboratory practices.
Fundamental Lab Courses:
Fundamentals of Dissolution: Guidance for the Verification and Qualification of a Dissolution Apparatus.
Compendial HPLC Practices: This course covers USP General Chapter <621> Chromatography, with focus on system suitability parameters and adjustments allowed to the chromatographic system. Additional topics covered in this course are HPLC theory, column selection and practice. Harmonization details will also be discussed.
Spectroscopy: This course will provide essential training and tools to assist the generation of spectroscopic measurement data that is ‘fit for purpose’ and which can be used with confidence for the manufacture and supply of drug substances, according to the requirements as specified in the US Pharmacopeia for the protection of human health around the World.
This course offers a comprehensive understanding of the new and revised suite of spectroscopic USP–NF General Chapters including:
- <852> Atomic Absorption Spectroscopy
- <1852> Atomic Absorption Spectroscopy - Theory and Practice
- <853> Fluorescence Spectroscopy
- <1853> Fluorescence Spectroscopy - Theory and Practice
- <854> Mid-Infrared Spectroscopy
- <1854> Mid-Infrared Spectroscopy - Theory and Practice
- <856> Near-Infrared Spectroscopy
- <1856> Near-Infrared Spectroscopy - Theory and Practice
- <857> Ultraviolet-Visible Spectroscopy
- <1857> Ultraviolet-Visible Spectroscopy - Theory and Practice
- <858> Raman Spectroscopy
- <1858> Raman Spectroscopy - Theory and Practice
This course will focus on the application of USP compendial requirements and perspectives in practical lab-based settings.
Supplemental Lab Courses (Students must complete 2 of the 3 courses)
Supplemental Courses provide the essential skills and tools for calculations, testing and recording of laboratory procedures.
Prospects can choose a minimum of two (2) of three Supplemental courses –
- Uniformity of Dosage Units: USP–NF General Chapter <905>,
- Understanding USP Requirements for Balances and/or
- Good Documenta