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
- Attain an understanding of the importance of both internal and external audits.
- Describe the relationship between FDA auditing activities and CGMP compliance through the Code of Federal Regulations (CFR) for pharmaceuticals.
- Identify audit findings from real company inspections.
- Explain do’s and don’ts for FDA audits.
- Distinguish the roles of company representatives during an audit.
- Relate the importance of proper documentation to provide evidence of compliance with CGMP.
- Perform an audit of a document used in the biopharma industry.
- Reasons for and the importance of audits
- What is fair game during an audit
- Preparing for an audit
- Do’s and don’ts
- Company responsibilities
- Preparation activities and documentation
- Review of 483s and warning letters
- Things to know about an FDA audit
- What to expect
- Auditor roles & rights
- Auditor responsibilities
- Review of sample documentation
- Attendance 100%
- Team Leaders and Supervisors
- Regulatory Personnel
- Quality Control Personnel
- Quality Assurance Personnel
- Manufacturing Technicians
- Administrative Personnel (scribes)
- Elements of Current Good Manufacturing Practices in Biomanufacturing Processes - SEF-79524
- Medical Devices, CGMPs and ISO Overview - SEF-414CL
- Good Documentation Practices and Data Integrity - SEF-211CL
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