To access the syllabus, visit Simple Syllabus and search by term and course.
Credits
This is a 3-credit course.
Description
Quality assurance refers to an organization’s policy to prevent problems from occurring. This is a very broad definition and is applicable to any laboratory conducting testing procedures on almost every conceivable product. Quality control (QC) is defined by ISO 9000 standards as:
“A part of quality management focused on fulfilling quality requirements.”
QA/QC therefore has a different meaning to different people depending on their particular area of expertise. For example, the EPA provides detailed guidelines for QA/QC of a laboratory conducting analysis for environmental contaminants, and these differ from the FDA’s requirements for a laboratory manufacturing or analyzing drugs under GMP or GLP conditions. To further complicate matters, there are numerousInternational guidelines becoming more and more prevalent as attempts are made to standardize qualityassurance programs.
Every graduate entering a career in an analytical, forensic, clinical, manufacturing or research facility will have to abide by some type of quality assurance program. This course teaches the key components of QA/QC and will help students to understand the need to produce sound scientific data using appropriate standards and controls, written procedures and method validation no matter what field they are employed in. This course will offer a generic description of what is required in the formation of a quality system in any laboratory. This will be achieved by describing the key principles in any QA/QC program with reference to the FDA, EPA and ISO guidelines, together with specific examples from different specializations in those particular fields.
Final exam
This course has a final online exam which students take at the end of the semester. The exam will be proctored using HonorLock (please see technical requirements on this website: https://app.honorlock.com/support/msr-check).
More information about HonorLock including a student orientation is provided on their website. You can check out the student guide tour on the HonorLock website: https://prep.honorlock.com/
In order to take the final exam, you will need the following equipment:
- Web camera or built-in camera for laptops
- Microphone (built-in with web camera or separate)
- Stable (preferably hard-wired) internet connection
If you have additional questions about the content of this course, please contact Clinical Professor & Director, Dr. Oliver Grundmann (grundman@ufl.edu).
Library Access
UF online graduate students enjoy the same library privileges as on-campus students. Visit the University of Florida Libraries to find books, journals and more.