Core Concepts in Biomanufacturing and Quality Systems: Applications of cGMPs
This 2-day 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
Live courses are currently suspended due to COVID-19.
- Lectures 0
- Hands-On Training 0
- Duration 16 hours
- Skill level All Levels
- Wet Lab Yes
- Max Students 16
- Assessments Yes