Course Description

Standard Operating Procedures (SOPs) are detailed written instructions that allow one to execute a process uniformly. Many SOPs are not well defined or well written, and actually fall short of providing the details needed for one to complete the process. In fact, many who are assigned the task of creating SOPs lack the basic understanding of what constitutes a well written SOP. Often SOPs appear to be no more than a brief Note to File, leaving gaps in the proper execution of the task delegated. Poorly written SOPs also leave organizations vulnerable in the event of an audit. In this web seminar, FDA Warning Letters will be reviewed to demonstrate the consequences of poorly written SOPs. This course offers guidance to those who recognize they need SOPs, or more detailed SOPs, but do not know how or where to start. Participants will be provided with guidelines and templates that ensure that new and updated SOPs are uniform and user-friendly.

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Learning Objectives

• Describe the purpose of SOPs
• Identify the basic elements of well written SOPs
• Design an SOP from the templates provided
• Link the SOP to other activities such as performance evaluations

Who Should Attend

• SOP Authors/Reviewers
• Research Site Administrators
• Clinical Monitors
• Study Coordinators
• Quality Assurance Auditors
• Project Mangers

Instructor

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

Jackie Stader, C.O.T., C.C.R.C.

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