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
- Explain the regulatory definition of medical devices.
- Describe the FDA regulation of medical devices.
- Identify aspects of FDA oversight.
- Discuss Quality Systems Regulations.
- Compare ad contrast ISO 13485 and QSR.
- Discuss the mechanics of ISO certification.
- Implement Good Documentation Practices.
- Navigate the FDA website and resources.
- Regulatory definition of medical devices
- Overview of medical device product types
- The role and responsibilities of the FDA in the regulation and oversight of medical devices
- Comparison of 21 CFR 820 (QSR) to ISO 13485
- Overview of good documentation practices
- Attendance 90% or above
- Medical Devices, CGMPs and ISO Overview - SEF-414CL
- Elements of Current Good Manufacturing Practices in Biomanufacturing Processes - SEF-79524
- Good Documentation Practices and Data Integrity - SEF-211CL
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