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 some of the first things FDA investigators will look at during an inspection.  Yet, in 2015, "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?

Join Susan Schniepp — a quality assurance thought leader veteran of 35 years —for a 1-hour session.

She’ll tell you what an SOP needs to be deemed “adequate” by the FDA — and she’ll tell you how to make SOPs so clear your employees will follow the plan the same way, each and every time.

Here’s what else you’ll learn:

  • 7 things to include in SOPs
  • 7 things — besides the procedure itself — that must be included
  • How to balance between streamlined efficiency and in-depth understanding
  • How good SOPs work together seamlessly
  • How to track evolution of SOPs
  • How to define SOPs roles for supervisors and operators
  • How to write SOPs for equipment, tools and calibration
  • Documentation output and the importance of evidence
  • Steps for when to involve quality assurance
  • When to initiate a formal investigation

Register today for SOPs advice from a proven industry leader.

  • 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

Susan J. Schniepp is a fellow at Regulatory Compliance Associates, Inc.  As a pharmaceutical quality assurance thought leader with 35 years’ experience, Sue has held leadership roles in industry at Allergy Laboratories, Inc., OsoBio Pharmaceuticals, LLC, Searle, Abbott and Hospira.  She has served as a member of PDA’s Board of Directors, PDA / FDA Joint Regulatory Affairs Conference Chair, conference presenter, and Chair of the PDA’s Regulatory Affairs / Quality Advisory Board, and was awarded PDA’s Distinguished Service Award in 2008.