FDAnews Announces — Writing Effective Standard Operating Procedures: Ensure Quality and Compliance From Step One Webinar, Aug. 13, 2015

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Standard operating procedures are one of the first things FDA investigators will look at during an inspection. This webinar, led by industry expert Andrew Harrison, will teach attendees how to effectively write SOPs that remove ambiguity for employees so that procedures can be followed exactly the same way, every time.

Writing Effective Standard Operating Procedures:
Ensure Quality and Compliance From Step One
**FDAnews Webinar**
Aug. 13, 2015 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/writingeffectivesops

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 demonstrate compliance and says to inspectors: “The manufacturers know what they are doing — and why.”

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

This webinar, led by industry expert Andrew Harrison, will teach attendees 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 attendees will learn how to avoid costly errors in processes that result in liability and FDA scrutiny. Attendees will also learn how to increase profits by running the operation more efficiently.

Specifically attendees 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.

Meet the Presenter:
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.

Who Will 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

Conference Details:
Writing Effective Standard Operating Procedures:
Ensure Quality and Compliance From Step One
**FDAnews Webinar**
Aug. 13, 2015 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/writingeffectivesops

Tuition:
$287 per site
Easy Ways to Register:
Online:     http://www.fdanews.com/writingeffectivesops
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
+1 (703) 538-7665
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