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.
Financial assistance is available for some Biotechnology courses!
You may qualify for a scholarship through the WakeWorks Propel program, or through other grant and scholarship opportunities.
Course Details & 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