Writing Standard Operating Procedures (SOP) Online Course & Certificate

There’s a belief among regulatory bodies: “If you didn’t write it down, it didn’t happen,” and while the regulations tell companies what they need to do and document, they don’t tell them how. Standard Operating Procedures (SOPs) are often used as training tools, which means that they need to be easily understood by all those whom they affect. Effective SOPs are not only a regulatory requirement; they also make good business sense. Often, employees fail to follow SOPs because they can’t understand them, and often, procedures are being constantly revised. This leads to lengthy and expensive investigations and costly revisions.

Writing Standard Operating Procedures is a course that presents a comprehensive overview of process writing that the regulatory agencies require. This course presents high level process writing of controlled documentation and gives industry standards for delivering information.

After completing Writing Standard Operating Procedures, students will be equipped with a basic understanding of the following:

• Students will gain a better understanding the regulatory expectations for, and the proper design and maintenance of effective and compliant Standard Operating Procedures.
• Students will also learn how to create and review SOPs, and generate a system for training and implementation of effective and compliant written procedures
• Students will learn how to write documents that ensure consistency in operations. A workshop in process writing gives participants the opportunity to actually write about a process and then assess the results. 
• Students will learn how to tighten and refine the language to produce clear and comprehensive documents.

No prior experience or coursework required. 

 Students will be assigned 5 homework assignments, and 1 final exam. 

1. Introduction to SOPs/Overview
2. Purpose of SOPS – need and their benefits
3. Preparations of SOPs – writing style, technicality based on target audience, clear crisp, general format of SOPs
4. Implementation, review and revision of SOPs
5. SOP training
6. Documentation control – numbering systems, tracking archival
7. Regulatory requirements of SOPs – requirements by OSHA, FDA, ICH, ISO, etc.
8. Types pf SOPs – Technical SOPs (analytical SOPs, sanitation SOPs, instrument SOPs, quality assurance SOP) and administrative SOPs (complaint processing SOPs, etc.)

 This course is Instructor-led and delivered through our award-winning online Learning Management System.