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
- Learn the regulatory definition of medical device.
- Describe the FDA regulation of medical devices (CDRH, combination products, classification).
- Identify aspects of FDA oversight (background, inspections).
- Recognize Quality Systems Requirements (21 CFR 820).
- Implement corrective and preventive action.
- Understand and utilize documentation and record-keeping systems.
- Participate in work sessions on Introduction to FDA resources and website.
- Practice the application of design, verification and validation concepts.
- Utilize medical device warning letters and perform root cause analysis.
- Discuss the mechanics of ISO certification.
- Introduction to medical devices (regulatory definition, an overview of industry and product types).
- The FDA's role and responsibilities in the regulation of medical devices (regulatory history, device classification system, clearance process, inspection, and enforcement).
- FDA oversight of medical device compliance ( 21 CFR 820, Guidance documents, ISO 13485, inspections).
- Activity: Navigating and utilizing the FDA's website and resources.
- Requirements of 21 CFR 820 (part one).
- Activity: The application of design, verification and validation concepts.
- Requirements of 21 CFR 820 (part two).
- Activities: Reviewing and utilizing existing warning letters; root cause analysis and corrections.
- Corrective and preventive action.
- Documents and records.
- ISO standards.
- Attendance 90% or above