Wake Tech offers a variety of non-degree, short classes and certificate training programs in the biotechnology field, including hands-on training in biomanufacturing and biopharmaceutical operations in a simulated industrial, current good manufacturing practices (cGMP) environment.
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