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Archive: Preparing for SOP Inspection: An Auditor's Perspective

December 5, 2013
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Course Description

Standard Operating Procedures (SOPs) are defined as detailed, written instructions that permit processes to be executed uniformly. In an effort to ensure compliance with regulations and guidelines, many sponsors, CROs, and clinical research sites have developed and incorporated SOPs into their operations. Too often, however, these documents are not reviewed critically and with enough frequency to make certain the information they convey is accurate and acceptable. Although training of staff and assessment of comprehension and compliance are crucial to implementation, the content and structure of SOPs should be routinely audited to take full advantage of their purpose. In this web seminar, we will discuss approaches to evaluating SOPs to ensure they are current and compliant.

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Learning Objectives

  • Examine the true purpose of SOPs and systems for compliant development, implementation, and management
  • Discuss the FDA’s new expectations for Sponsor/ CRO and Clinical Investigator SOPs
  • Review recent case studies concerning issues in SOP documentation and implementation practices

Who Should Attend

  • SOP Authors/Reviewers
  • Quality Assurance Auditors
  • Clinical Monitors
  • Site Managers
  • Line Function Heads
  • Project Managers

Instructor

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

Elizabeth Ronk Nelson, M.P.H.

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