Writing Effective SOPs

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.

Audience

Biomanufacturing, Bioprocessing, Pharmaceutical, Medical Device, Cosmetics, and other FDA regulated industry sectors.

Topics Include

FDA Expectations
What SOPs Do We Need?
Document types
Process mapping to identify needed documents
What Makes an SOP Effective?
SOP Critique
SOP Format
SOP Language and Detail
SOP Numbering/Organization
SOP Review and Approval
SOP Distribution and Control
SOP Changes
Data Collection Forms (DCFs) and Batch Records
SOP Writing

Learning Objectives

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.