Students will learn how to write an effective Standard Operating Procedure (SOP) as well as why these are a required and essential component of documentation systems in regulated industries. Discussion will include the functional areas in which SOPs are needed, the qualities that make them effective, and the importance of keeping these current. Students will learn how to structure an SOP and the content that should be included. Hands-on activities include reviewing and critiquing an SOP for completeness and effectiveness, as well as practice writing SOPs.
Biomanufacturing, Bioprocessing, Pharmaceutical, Medical Device, Cosmetics, and other FDA regulated industry sectors.
- 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.
- 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.
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