The BioNetwork Capstone Center provides affordable, high-quality, hands-on training in biotechnology, biomanufacturing, and biopharmaceutical/pharmaceutical operations in a simulated industrial (cGMP) environment.
The Capstone Center is situated in the Golden LEAF Biomanufacturing Training and Education Center (BTEC) at North Carolina State University Centennial Campus. It provides a training environment that mirrors a biomanufacturing plant facility with state-of-the-art classrooms, industrial-grade equipment laboratories, and a certified cleanroom suite.
Industry-recognized credential: BioNetwork Capstone Certificates
Complete in: 12 months or less
Course Details & Registration Information
- Understand FDA required documents and record requirements for pharmaceuticals.
- Understand how to compliantly record and maintain data whether in hard-copy or electronic format.
- Participants will learn regulatory expectations for data accuracy, review and integrity assurance.
- FDAs requirements for documents and record keeping defined in 21 CFR 211.
- Differences, useage and purpose of documents typically found in pharmaceutical systems
- Good documentation practices as well as common errors and data omissions that occur in pharmaceutical documentation.
- Electronic signature and electronic record keeping requirements of 21 CFR Part 11
- Regulatory definition of raw data and the emerging regulatory expectations for data integrity
- Attendance 80% or above