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
- 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