Writing SOPs: Best Practices for Life Science Companies

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Writing SOPs
Best Practices for Life Science Companies

Your standard operating procedures are one of the first things FDA investigators will look at during an inspection. Yet, "inadequate SOPs" rank among the most-frequently cited Form 483 observations.

A well-written SOP helps you demonstrate your compliance and say to inspectors: “We know what we are doing — and why.”

But what exactly does an SOP need to contain to be “adequate?” What information, if any, should be omitted? How do you write them so that employees can easily understand and follow them, and when do they need to be changed?

This new management report will teach you the practical techniques you need for crafting well-written, fast-read, flexible and compliant SOPs — SOPs that will meet FDA requirements as well as today’s globalized expectations.

You’ll learn how to effectively write SOPs that remove ambiguity for employees so that procedures can be followed exactly the same way, every time. You will also learn:

  • Best practices for SOP development, including the characteristics of a good SOP;

  • Regulatory requirements for SOPs from the FDA and EMA;

  • Lessons from FDA warning letters;

  • The business costs of poor SOPs;

  • What a process map is and how to create one;

  • Why SOP metrics are important to a culture of compliance;

  • Which metrics matter to management, and to the FDA;

  • Advanced SOP strategies, including how to save time and reduce overhead in SOP development;

  • How to best use visuals in SOPs;

  • Cautions and frequent mistakes in SOPs;

  • How to maintain and control SOPs;

  • How to oversee and ensure self-compliance; and

  • How to make SOP training stick.

For your easy reference, the report also includes checklists and templates for your use in writing SOPs as well as examples of good SOPS.

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Table of Contents

  • Introduction
  • Regulatory Requirements for SOPs
  • Best Practices for SOP Development
  • Writing for the Right Audience
  • And More …

View the entire TOC

Who Will Benefit

  • Executive management
  • Regulatory Affairs officers
  • Quality Assurance/Quality Control managers
  • Legal and Compliance Officers
  • Clinical research directors
  • Consultants/service providers
  • CAPA specialists
  • Compliance information managers
  • GMP compliance officers
  • GMP training managers
  • Heads of internal audits
  • QA documentation managers
  • Quality systems managers
  • Systems analysts
  • Training personnel

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