Core Concepts of Biomanufacturing and Quality Systems (Live)

This course provides future or current employees a comprehensive and applied understanding of how regulatory compliance is built into all aspects of a company. Using a blend of hands-on applications and lectures, course instructors integrate current Good Manufacturing Practices with core concepts of the manufacturing process, facilities, quality systems, and documentation to build a solid understanding of the development, manufacture, testing, and release of a regulated product.

• Identify primary aspects of regulatory compliance with respect to departmental roles and responsibilities
• Gain a working knowledge of cGMPs and the relationship between compliance and risk management
• Apply cGMPs to the manufacture, testing, and release for sale of a regulated product
• Demonstrate the use of industry-specific documentation to meet cGMP requirements
• Understand the correlation of facility, equipment, and process control via qualification and validation

This course is scheduled for November 18-19, 2021, 9:00am – 5:00pm on both days. Please note that the class size is limited to 8 people.

All of us at the University of Florida have an obligation to each do our part to prevent further transmission of COVID-19.  It is the right thing to do — and medical experts say vaccination and masking are the best ways to do it. Therefore, we are advising you of the following steps we are taking in our efforts to ensure a safe and successful live course. Effective immediately, in light of new guidance from the Centers for Disease Control and Prevention, it is expected that everyone will wear a mask at all times when inside any UF facility, even if you are vaccinated. This includes students, faculty, staff, vendors and visitors. Recent studies and guidance from the CDC state that both unvaccinated and vaccinated individuals can transmit the current COVID-19 variant to unvaccinated persons.