Course Description:
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 <85x>/<185x> 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.
Upon completion of Module 1 of this course, participants will be able to:
- Explain the interaction between the Spectroscopic and the associated and appropriate General Chapters
- Interpret the compendial applications of the spectroscopic techniques
- Describe the compendial procedural details and best practices for each of the spectroscopic techniques
- Evaluate the qualifications of spectroscopy-based systems
Upon completion of Module 2 of the course, participants will be able to:
- Interpret the requirements necessary to qualify technique-specific instrumentation
- Evaluate data analysis techniques for multivariate spectroscopic data
- Implement appropriate spectroscopic data analysis techniques
- Interpret technique-specific validation requirements
- Interpret technique-specific verification requirements
This course is intended for learners who are well-conversant in chemical terminology and chemical fundamentals/theory and are also relatively new to pharmacology and pharmaceutical research. Participants should have at least two (2) years’ theoretical and working knowledge of any or all spectroscopic techniques being taught. Participants should also have a basic knowledge of Good Laboratory Practices and metrology. Suggested professional roles for participants include, but are not limited to:
- Analytical lab managers
- Analytical scientists
- Instrument manufacturers
- QC scientists
- Method validation specialists
- CMC reviewers
- QA specialists
- Regulatory professionals
- Pharmaceutical scientists