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
- Determine risk assessments and test acceptance criteria based on guidance documents, the validation life cycle, requirements, and system specification documents.
- Develop test documentation for automated equipment and process control systems validation.
- Demonstrate capabilities in testing and accurately reporting discrepancies/deviations and conclusions to meet regulatory audit expectations including traceability of testing performed as needed for audits.
- Types of automated equipment/process control systems
- CGMPs and regulatory requirements
- Industry guidance documents/ documentation requirements
- Part 11- Electronic Records/Signatures
- GAMP 5 Life Cycle
- Risk and Impact Assessments
- Validation test plan and development
- Creating validation documentation
- Handling discrepancies/deviations during testing
- Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ)
- Maintaining the validated state
- Attendance 90% or above
- Introduction to Computer Validation - SEF-79534
- Computer Application Validation - SEF-79844
- Fundamentals of Validation - SEF-165CL