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
Course details and registration information
- Define the elements of current Good Manufacturing Practices (CGMP) for biomanufacturing and pharmaceutical production.
- Explain how CGMP helps regulated companies comply with the law: Part 21 of the Code of Federal Regulations (21 CFR 211).
- Understand the importance of current Good Documentation Practices (CGDP) for pharmaceuticals and Part 11 of the Code of Federal Regulations (Electronic Record Keeping).
- Recognize the consequences of failing to comply with CGMP.
- The mission of the FDA
- The quality assurance role
- Personnel and organization
- Buildings and facilities
- Control of components, drug product containers, and closures
- Production and process controls
- Packaging and labeling
- Holding and distribution
- Laboratory controls
- Records and reports
- Return and salvaged drug products
- Complaints and recalls
- Good Documentation Practices (GDP)
- Computer systems (Part 11)
- Regulatory enforcement
- Attendance 100%
- Manufacturing Technicians
- Team Leaders and Supervisors
- Quality Control Personnel
- Quality Assurance Personnel
- Medical Devices, CGMPs and ISO Overview - SEF-414CL
- Elements of Current Good Manufacturing Practices in Biomanufacturing Processes - SEF-79524