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.
Guest speakers from Glaxo SmithKline, Global Biotech Experts, LLC, and EcoLab Life Sciences.

This course is not limited to UMBC students and is open to the general public. This course is offered in our Live Online Synchronous format.  All lectures will be recorded to accommodate international students and professionals with challenging schedules.

 Session Detail: 2228CERTBIOT108P201

Schedule: Every week on Thursday, starting on 09/01/22 and ending on 12/08/22
Times: 06:00pm - 08:45pm
REGULAR PRICE : $1500.00

Facility Detail

Live Online Synchronous
Live Online Synchronous: (LOS)
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Live Online Synchronous: (LOS)