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.
Participants in this course will:
• 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
CCB is an elective course in the Document Management, Operations Management, and Quality Management certificate pathways.
This course is available online, and can be taken anytime, anywhere.
This course is also available live online (given online, at a prescheduled time, by a live instructor). The next live online course will be given on Tuesday, September 8, 2020, at 2pm ET.
