Developing Effective Standard Operating Procedures (SOPs)

SOPs represent your company’s interpretation of steps needed to comply with regulations. Companies face regulatory sanctions if they are lacking SOPs for critical processes, or if their SOPs are inadequate.

Failure to follow a company’s own procedures is one of the most common observations found during FDA inspections. This program targets personnel that are, or will be, responsible for the development, review and approval, document control, and training of your company’s SOPs. 

This course can be customized to meet your company’s specific needs. You can select from our listed topics or we can incorporate other relevant topics that you request. 

Examples of 483s, Warning Letters or other official action will be included, as appropriate.

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Suggested Topics

  • Purpose of having SOPs
  • FDA expectations
  • Needs Analysis
  • Developing and writing SOPs
  • Reviewing and approving
  • Document control
  • Conducting effective SOP training
  • Developing training assessments

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