Writing and Enforcing SOPs: Best Practices for Regulated Industries

Duration: 12 Hours
Course Instructor

Louis Angelucci

$ 2330
Discounts: We offer a 10% group discount when you register 2 or more attendees (up to 10). Contact us for groups over 10.

Course description

View Course Outline

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
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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.

Beginner 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 Manager, Engineers and Auditors
  • Process and Production Supervisors
  • Quality Assurance and Control Professionals
  • Validation Engineers

Course Instructor


Louis Angelucci

Consultant for the Pharmaceutical Industry

Louis Angelucci’s Courses


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Individual courses are remarkably effective. But sometimes when you have a specific need, it helps to have expert guidance right in the room with you and your team.

In that case, we’re happy to design a custom training for your entire team, whether online—or on-site.

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