Writing Standard Operating Procedures (SOP) for FDA-Regulated Industry

Standard Operating Procedures Course Description

Writing and enforcing effective standard operating procedures (SOPs) can be challenging. Poorly written SOPs are one of the most common causes of deficiencies and observations cited in 483s and warning letters from the FDA. Companies in regulated industries must know how to organize and deliver information for the intended audience and the intended purpose.

Participants will learn how to organize and deliver information for the intended audience and purpose. They will learn how to write clear and readable documents, and how to revise and refine their own and others’ writing.

This 12-hour accredited training will cover practical guidance on the purpose of Standard Operating Procedures as well as the requirements from regulators for SOPs. Guidance will be provided on how to write from the reader’s perspective, and how to structure SOPs so that they are accurate, concise, and to the point. Tips on formatting SOPs will be given. Examples of current FDA finding for SOP deficiencies will be given and discussed. Practical and effective SOPs templates will be shared with the participants. This course will provide guidance for team writing of SOPs, as well as best practices for SOP distribution. Good documentation practices will also be discussed.

Training Agenda

Review of Learning Objectives

Purpose of Standard Operating Procedures

• 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

How to Develop/Write effective written correspondence

• Use of specific words when writing instruction

How to write to the audience

• Know how to organize and deliver information based on the message
• Understand how to structure SOPs

Understand the innate structures of English grammar

• How to create grammatically sound passages
• How the active and passive voices work and how to choose the most appropriate one for the type of writing you are doing

Team writing SOPs

• Advantages
• Creating buy in
• Training the Trainer

SOP writing for Participants

• Participants will be given a topic and asked to write a short SOP, they will have time to discuss how they would approach the writing with a team.

Reviewing and Revising SOPs

Final Questions/Comments/ Discussion

Understanding writing Patterns

• Knowing the answers to questions about the English language

Confidence in writing and revising SOPs

• Practice writing and revising

SOP Distribution

• Routing SOPs for approval
• Role of document control
• Training
• Effective dates

Enforcing SOPs

• Management’s role
• Quality Assurance’s role
• Personnel’s role

Good Documentation Practices

• General requirements
• GDP basics
• Record control
• Modifying records in a compliant manner
• Attachments and printouts
• Examples of documentation errors with attendee participation

Final questions/Answers/Comments

Assessment Opportunity

Who Should Attend?

This course is intended for all personnel directly involved in the development of standard operating procedures including those responsible for writing validation protocols or execution activities. Beginning or seasoned operational personnel who will participate in team writing and individuals in management who communicate with regulatory agency inspectors will also benefit from attending this course.

There are no prerequisites for attending, but a basic knowledge of good manufacturing practices is helpful.

The course will be especially beneficial to:

• Quality managers, engineers and auditors
• Quality Assurance and Control professionals
• Process and production supervisors
• Validation engineers