Writing Effective Standard Operating Procedures - Webinar CD/Transcript

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Writing Effective Standard Operating Procedures: Ensure Quality and Compliance From Step One

Your standard operating procedures are one of the first things FDA investigators will look at during an inspection.  Yet, in 2014, "inadequate SOPs" was once again a Top 5 most-frequently-cited Form 483 observation.

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 presentation led by industry expert Andrew Harrison will teach you how to effectively write SOPs that remove ambiguity for employees so that procedures can be followed exactly the same way, every time.

In 90 minutes you’ll learn how to avoid costly errors in your processes that result in liability and FDA scrutiny.  You’ll also learn how to increase your profits by running your operation more efficiently.

Specifically you will learn:

  • 7 things to include in SOPs;
  • 7 things besides the procedure itself that must be included;
  • The balance between streamlined efficiency versus in-depth understanding;
  • How good SOPs work together seamlessly;
  • Systems for tracking how SOPs evolve over time;
  • How to define roles in SOPs for supervisors and operators;
  • How to write SOPs for equipment, tools and calibration;
  • Understanding documentation output and the importance of evidence;
  • Steps for when to involve quality assurance; and
  • When to initiate a formal investigation.

This course will be of benefit:

  • Executive Management
  • Regulatory Affairs
  • Quality Assurance/Quality Control
  • 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
  • QA/QC Managers and Directors
  • Quality Systems Managers
  • Systems Analysts
  • Training Personnel

Andrew Harrison is the Chief Regulatory Affairs Officer & General Counsel at Regulatory Compliance Associates, Inc. Prior to that, he was Vice President, Global Quality Compliance & Audit at GE Healthcare where he won the Chief Quality Officer’s award in 2012. He has over fourteen years of experience as a highly-accomplished Quality & Regulatory compliance leader, attorney and competitive differentiator across the Medical Device, Pharmaceutical and Biotechnology sectors. He is an Illinois-licensed attorney and an industry speaker in key forums on various regulatory & legal topics.