Courses

QUALITY CONTROL AND QUALITY ASSURANCE FOR BIOTECHNOLOGY PRODUCTS: In-depth coverage of the key issues associated with adequate quality-control systems, assays and stability for novel biotechnology products: quality concepts, product release testing and specifications, in-process testing, product characterization, quality assurance documentation and audits and vendor certification.

This course will examine the biological basis of a pandemic, and how COVID-19 has informed our current approaches to relevant topics in biotechnology, such as technical development and regulatory and compliance, epidemiology, biosafety and biosecurity, data science, public health and policy considerations. We will also be examining the historical, ethical and public health perspectives that accompany pandemics.

Price: $1,500

DEVELOPMENT AND REGULATION OF BIOPHARMACEUTICALS: This course provides a comprehensive coverage of all steps involved with the regulatory approval process for a biotechnology-derived product. Documentation preparation for IND, NDA, BLA. Pre-clinical safety data, clinical studies, facilities inspection and scientific and regulatory principles.

Price: $1,500

BREWING I: FROM RAW MATERIALS TO FERMENTABLE WORT: The rapidly expanding local brewing industry, including large, mid-sized, and small breweries, provides new and unique employment opportunities for STEM graduates in Maryland. At its core, brewing is a chemical/biochemical enterprise, and our chemistry/biochemistry students are well poised to occupy key technical roles not only as brewers, but also in areas such as materials acquisition and quality control. This interdisciplinary course provides an in-depth exploration of the chemical and biochemical processes fundamental to the different stages of the brewing process. Topics will include water chemistry, malting and grain processing, the organic chemistry of hops, and the biochemistry of wort production. Integral to the course is the exploration of how fundamental chemical and biochemical processes affect different aspects of the brewing process as well as specific qualities of the beer produced.

Mondays 6:30-7:30 beginning 8/31/21

This course is not limited to UMBC students and is open to the general public.

DEVICES AND COMBINATION PRODUCTS: Over the last decade, the number of medicines needed for delivery via medical devices has grown exponentially. These products have made the development and approval process more complex. The way in which these products are treated by regulators has also changed and evolved, as has the way in which they are used. Taught by renowned professors and experts from industry, this course teaches the ins and outs of the rapidly growing combination products market. Learn about combination product lifecycle management and the regulatory environment for these products. 

Price: $1,500