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:
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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:
When you need on-site attention, we’re not just here to help, we’re there to help—right by your side.
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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