Course Description

No one really likes reading SOPs. Whether this is a true “necessary evil” or not, this, in itself, makes it important that the associated pain is minimized. More often than not, the contents of the SOPs are simply “tossed” into a document with little ado. Such an approach perpetuates a vicious circle: First, the user, not being able to fully comprehend what they are reading, simply stops reading; then, authors, knowing the document won’t be read, don’t put effort into writing it. The by-product of these events is that compliance suffers. Fortunately, there is a way to break out of this circle: (1) develop documents that SOP users can understand; and (2) present the contents in an easy to view way. Regardless of the content, the better its presentation, the more likely the document is to be read and used. In this web seminar, we will touch upon the approaches to creating more usable SOPs through:

• Improving their readability, including the use of words and expressions that help avoid noncompliance without compromising the contents.
• Presentation of the contents (through layout, formatting, and templates).

We will also consider how to maintain the usability of globally applicable documents across all geographic regions.

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Learning Objectives

• Review approaches to translating the process into readable and usable text, while minimizing regulatory compliance risk
• Implement templates as a tool in improving quality of procedural documents
• Discuss the impact of documents’ global applicability on their readability

Who Should Attend

• SOP Authors/Reviewers
• Quality Assurance Auditors and other Quality Management Professionals
• Clinical Research Associates
• Site Managers
• Line Function Heads
• Project Managers

Instructor

The course will be led by one of the following instructors:

Irina Colligon

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Hold this course at your company! For more information, contact Naila Ganatra at +1 215.413.2471.