Writing and Enforcing SOPs: Best Practices for Regulated Industries

Louis Angelucci

Course description

Organizations often face challenges when creating and enforcing effective standard operating procedures (SOPs). Poorly written SOPs are a common cause of deficiencies and observations mentioned in 483s and warning letters issued by the FDA. Therefore, companies operating in regulated industries must understand how to organize and present information for the intended audience and purpose. To address this issue, this training course offers guidance on how to write effective Standard Operating Procedures and Work Instructions to support company activities.

Throughout the course, participants will learn how to organize and present information for the intended audience and purpose, as well as how to write clear and readable documents while revising and refining their own and others’ writing.

The course provides practical guidance on the purpose and regulatory requirements for SOPs, with a focus on writing from the reader’s perspective. Participants will also learn how to structure SOPs to be accurate, concise, and to the point, as well as tips on formatting.

Additionally, the course includes discussions on current FDA findings regarding SOP deficiencies and offers practical and effective SOP templates. It also provides guidance for team writing of SOPs and best practices for SOP distribution while discussing good documentation practices.

Upon completion of this course, you will be able to:

• Explain the mandates for SOP documentation set forth by the regulators, such as the Food and Drug Administration (FDA), the International Organization for Standardization (ISO), and other governing bodies
• Produce effective written correspondence
• Assess and write to the audience
• Organize and deliver information based on the message
• Structure SOPs using proper English grammar including proper voice and punctuation
• Review and revise SOPs and Work Instructions
• Demonstrate skills in writing and revising documents
• Explain the basics of Good Documentation Practices