Core Concepts of Biomanufacturing and Quality Systems (CCB)

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 August 19 and 20, 2021, 9:00am – 5:00pm on both days.

Please note that the class size is limited to 12 people, Masks are strongly encouraged, and social distancing will apply where possible.