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
- Explain the regulatory and business rationale for SOPs.
- Identify FDA expectations.
- Define at least 2 approaches for determining what SOPs are needed.
- Identify factors that support SOP efficacy.
- Distinguish between methods of presenting SOP content.
- Analyze the structure and content of an SOP for adherence to the principles of effective SOP construction.
- Create an SOP utilizing the principles learned in class.
- Understand how to keep their SOPs current.
- Lecture - principles, philosophy, regulatory compliance.
- Examples - overview and analysis of SOP examples for effectiveness.
- Writing exercise - creation of an SOP per the principles discussed in class.
- Attendance 95% or above
- Good Documentation Practices and Data Integrity - SEF-211CL
- Elements of Current Good Manufacturing Practices in Biomanufacturing Processes - SEF-79524