MedTech I.Q.

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Effective Ways to Prepare a Standard Operating Procedure (SOP)

Technically, all FDA inspections include a Standard Operating Procedures (SOPs) review. Deficiencies in the SOP constitute a large number of the FDA's inspectional observations of organizations. The reason for this occurrence is that although SOPs are required for companies in the regulated industries, there are no clear-cut guidelines laid out by the regulatory bodies on the ways of writing, maintaining, and updating SOPs.

In the absence of these guidelines, many organizations end up preparing SOPs in a manner that makes compliance difficult. Many a time, the poor manner of their writing, communication, monitoring and enforcement proves to be their undoing. More often than not, SOPs are either inadequate or they miss important elements, or they lack tools to increase compliance with the SOPs. All of these make it difficult for the employees to understand them. They contain many errors or delays that only get discovered during an audit.

The key to avoiding punitive actions from the FDA is to thus design and write SOPs in a way that makes them easy to maintain and update. How do organizations do this? This is the learning a webinar from will teach.

This webinar will instruct the participants how to write, maintain, and update SOPs to ensure compliance. At this webinar, Todd B. Graham, who is a clinical laboratory scientist for a large hospital system in the New York Tri-State Area, will be the speaker. Please visit to enroll for this session.


The main learning this webinar will offer is a set of guidelines on how to write SOPs and work instructions for FDA-regulated organizations. This learning will help participants with the following:

  • They will become familiar with the basics of how to generate a great SOP
  • They will understand how to remain compliant and yet not restrict the course of action
  • They will gain knowledge of how to maintain the compliance over the course of the SOP lifetime.

This is a comprehensive learning session at which Todd will cover all the areas relating to how to write SOPs and work instructions for FDA-regulated organizations. These include:

  • Record compliance with examples
  • What are SOPs?
  • Why are they important?
  • What are their benefits?
  • What are their limitations?
  • Important types of SOPs
  • Minimum number for SOPs, topics, and examples
  • SOPs and guidelines


Steps to develop an SOP


  • Process mapping
  • Authoring
  • Formatting and language
  • Editing
  • Authorizing
  • Training
  • Implementation
  • Revision / archiving (version control)
  • An SOP example and template

-------------------------------------------------------------------------------------------------------------- About the speaker: As a scientific consultant for Fortune 500 biotechnology firms, healthcare systems throughout the world and R1 Research Level Universities, Todd has improved sample workflow and improved laboratory quality and sample turnaround time while expanding laboratory services to vulnerable health populations in the New York area. He has also provided outreach to the local community by serving as a mentor to students training in clinical laboratory science, as well as the scientific community by serving as a technical resource for his peers in the laboratory.

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