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Course Detail: BIOT108 - QUALITY CONTROL AND QUALITY ASSURANCE FOR BIOTECHNOLOGY PRODUCTS (BTEC 664)
Upon completion of this course students will learn about topics such Quality Control Methods, QC Microbiology, Bioassay Design, Experimental Design, QC Package for rDNA Products, QC Package for Monoclonal Antibody, Assay Validation, Qualification and Transfer, Elements of QA in a Multiproduct Facility, Comparability, and Barr Decision, OOS, and QbD.The following are the goals for this course:
- To provide students with an in-depth understanding of how to develop a QC strategy for a biotechnology product.
- To provide students with knowledge on QC methodology, its development and validation during the product life cycle, i.e. pre-IND through market approval.
- To provide students with a clear appreciation of how a QC/QA package looks like for a biotechnology product.
This course is open to the general public-not limited to UMBC students. The course is offered as both a Virtual and In-Person format. All lectures will be recorded to accommodate international students and professionals with challenging schedules.