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
- Define and distinguish pharmaceutical documents and records.
- Detail the regulatory requirements, functional purpose, and typical industrial uses of each document type.
- Review 21 CFR 11 requirements and resultant impacts on electronic signatures and record keeping.
- Recognize emerging regulatory expectations for data handling and data integrity assurance.
- GMP documents
- GMP records
- Document control
- Good documentation practices
- 21 CFR Part 211
- Electronic records
- Qualifying Excel spreadsheets
- Data integrity
- Medicines & healthcare products regulatory agency
- Attendance 100%
- Pharmaceutical Production Associates
- Production Managers
- Quality Managers
- Medical Devices, CGMPs and ISO Overview - SEF-414CL
- Elements of Current Good Manufacturing Practices in Biomanufacturing Processes - SEF-79524