Chemometrics for the Pharmaceutical Scientist

Chemometrics for the Pharmaceutical Scientist will not be offered in Fall 2015. Please continue to check this website, as course offerings may be updated in the future.

About the Course:

Chemometrics is becoming a critical tool in the pharmaceutical industry as understanding and developing a control strategy become esstential to ensuring that the quality of the finished drug product meets regulatory demands. Chemometrics is also essential for implementation, process analytical technology (PAT), Quality by Design (QbD), and Real Time Release Testing (RTRT).

Through in-depth lectures, tutorials, and laboratory exercises, this course will introduce participants to chemometrics implementation in product development and manufacturing. The course will address the basics of chemometrics and spectroscopy, including near infrared and Raman spectroscopy, as well as the application of the different techniques to data generated during the laboratory exercises. Participants will be led through the entire process -- from data collection to model development, validation, and implementation -- in a systematic way, which will give them a comprehensive understanding and demonstrate the successful application of relevant chemometric techniques to process and end product data.

Course Objectives:

By the end of the course, participants will be able to:

  • Apply basic chemometrics to process and end product data.
  • Adopt different strategies for developing models for identification.
  • Process and release tests, including:
    • raw material identification
    • blend homogeneity
    • drying
    • coating
    • drug layering
    • dissolution
    • content uniformity
  • Use chemometrics and process data to monitor and control pharmaceutical unit operations.
  • Understand regulatory approaches to the role of chemometric models.

Who Should Attend:

This course is designed for industrial researchers who work in formulation development, process development, quality control, and administration. It is also ideal for regulators from the Food and Drug Administration (FDA) who work in CMC review, field inspection, and research involving product quality evaluation.

No prior knowledge is needed to begin this course, although some knowledge of basic statistics and elementary linear algebra is useful. Participants are required to bring laptops to perform the different exercises.

For More Information:

For additional information or questions about the course, please email shortcourse@rx.umaryland.edu.