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Developing Standard Operating Procedures


How does a standard operating procedure (SOP) withstand US Food and Drug Administration (FDA) scrutiny? One of the best ways to ensure that an organization meets its business and regulatory obligations is to follow SOPs, which are standardized procedures and processes to ensure that similar tasks are done the same way every time. This online training course explores what SOPs are, their uses, how to write them, their importance to an organization, and how specific SOPs are used in various organizations. Course Level: Beginner

What you will learn

  • SOPs and the benefits of having SOPs
  • Outlining procedures for SOPs
  • Writing SOPs, including formats, administrative issues, and content
  • Organizational issues for SOPs
  • SOP training and implementation

Who should attend?

Professionals involved in:

  • Clinical research and development
  • Quality assurance
  • Regulatory affairs
  • Clinical supplies
  • Data management
  • SOP administration
  • Clinical site operations

Learning objectives

At the conclusion of this activity, participants should be able to:

  • Describe the role and function of SOPs and their importance to an organization
  • Discuss various formats of SOPs
  • Discuss SOPs for different functions
  • Recognize the importance of training with respect to SOPs