Course Description
Principles to understand and establish quality control/quality assurance processes, procedures, and compliance reports for the production of biologics, drugs, and devices.
Athena Title
QC and QA
Equivalent Courses
Not open to students with credit in PHAR 6100E
Non-Traditional Format
Three hours per week for fifteen weeks online study, including teaching, assignments, discussion, problem-based learning, and case-based learning. Weekend seminars totaling eight contact hours (onsite or GSAMS multi-point video conference) utilizing case-based and problem-based learning methods.
Prerequisite
PHAR 6030 or PHAR 6030E or permission of department
Grading System
A - F (Traditional)
Course Objectives
Upon successful completion of this course, student will be able to: Compare and contrast industry applications of modern quality management techniques, including implementation of quality systems approaches, to all aspects of production and quality assurance Identify common risk-based approaches used by the industry Analyze regulatory review and inspection policies based on state-of-the-art pharmaceutical science Determine ways to integrate quality systems approaches into manufacturing processes that meet FDA regulatory review and inspection policies
Topical Outline
Highlights principles of quality control/ quality assurance for production of biologics and drugs, importance of implementing maintaining quality systems during development, standard operating procedures, audit reports for compliance with cGMPs and FDA inspections. Will use case studies to employ costs control methods, perform productivity, statistical analysis.