Wake Tech offers a variety of non-degree, short classes and certificate training programs in biotechnology, including hands-on training in biomanufacturing and biopharmaceutical operations in a simulated industrial, current good manufacturing practices (cGMP) environment.
For those interested in earning a degree to work in the biotech industry, visit Wake Tech's Biotechnology Department.
Financial assistance available
Workforce Continuing Education offers financial assistance for many workforce training programs through the Propel program and other resources. Email [email protected] for more information.
Course details and registration information
- Understand FDA required documents and record requirements for medical devices.
- 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.
- FDA's requirements for documents and record keeping defined in 21 CFR 820 and ISO 13485.
- Differences, usage and purpose of documents typically found in the medical device industry.
- Good documentation practices as well as common errors and data omissions that occur in medical device 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 100%
- Manufacture/Production Operators
- Team Leaders and Supervisors
- Quality Control Personnel
- Quality Assurance Personnel
- Maintenance/Engineering Personnel
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