Remember – at checkout you can choose to take this course On-demand. We offer a 10% group discount when you register 2 of more attendees (up to 10). Contact us for larger groups.

“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.

This course will address how to write effective Standard Operating Procedures and Work Instructions in support of company activities. 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 ON DEMAND 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.”