Courses

Training within the high-demand life sciences / biotechnology industry to workers that have been displaced due to COVID-19.


This course contains no sessions
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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.

Price: $1,500



September 1, 2022 to December 8, 2022, Live Online Synchronous: (LOS)

This course presents an in-depth coverage of the development and implementation of current good manufacturing practices (CGMPs) in the biotech industry. The course will include lectures given by experts in the topics covered and participants will engage in case studies that will provide real world exposure to the application of CGMPs in bio-manufacturing. Topics discussed include building and facilities, equipment design, utilities, process technologies, in-process controls, GMP documentation, and process validation.



This course contains no sessions
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This course presents an in-depth discussion of the engineering design of biotechnology manufacturing facilities under GMP compliance. Topics covered include architectural considerations, bulk plant design, process equipment design, utilities, instrumentation, controls and computerization, facility and equipment validation and trends for future facilities. Participants will be engaged in case studies, virtual facility tours and hands-on facility design projects.


This course contains no sessions
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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



August 31, 2022 to December 7, 2022, Live Online Synchronous: (LOS)

CELL AND GENE THERAPY: This course builds on general interest in the cutting-edge realms of pharma, specifically cell and gene therapies. Students will explore the new age of digital medicines, personalized medicines, single treatment (one and done) therapies and the requirements put upon the innovators and manufacturers of these products.


Price: $1,500



September 1, 2022 to December 15, 2022, Live Online Synchronous: (LOS)

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



September 6, 2022 to December 13, 2022, Live Online Synchronous: (LOS)