Description
This course in technical writing is designed to introduce the student to the complexity of documentation in the biomanufacturing environment. Students will discover the role of Quality Assurance in the day-to-day operations of the manufacturing facility. Following the Code of Federal Regulations (CFR), students will learn the process of writing and following standard operating procedures (SOPs), deviation reports, corrective action/prevention action reports (CAPAs), and change control reports among others. Students will design a manufacturing company following strict CFR guidelines. The importance of integrity in documentation will be emphasized for maintaining high quality products.