Food & Drug Regulation

Save Our Procedures! How to Effectively Write and Evaluate Standard Operating Procedures

Presented by Kristina Barkhouser
Recorded On: Tuesday, October 23, 2012
Duration: 90 minutes
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SOP - those three little letters can wreak havoc on organizations and are involved in numerous observations by regulators.  Having a good understanding of what should and should not be in a "written procedure", and how to author and manage them effectively, is a key skill for which few people have ever received training.  Is your organization bogged down in an SOP writing and management style developed by employees who are long gone?  You don't have to start from scratch, but the concepts gained from this training could certainly help you begin the process of saving your procedures.

This webinar will equip you with the information you need to effectively write and evaluate your organization's SOPs.  From determining the need, scope and purpose of the SOP to maintaining and applying your SOPs in an effective and compliant manner, you'll gain practical insight on each step of the process. 

Whether you are an SOP end user, author, approver, or member of the Quality department, understanding the key features of effective AND ineffective SOPs could save your organization from tragic mistakes and regulatory action. 

Key Learning Points:

  • To put it in writing, or not to put it in writing...that is the question.  The answer will surprise you!
  • The lifecycle of an SOP.  Are yours on death row?
  • The essential elements and structure of a compliant and useful SOP, from everyone's perspective, not just the author's.
  • What is the "meat" and what are the "potatoes" of a well written SOP?  Following the right recipe ensures a successful end result.
  • When to use "bells and whistles" in an SOP and when to avoid them.
  • The role of the author, the approver and the Quality department in the SOP process - a partnering perspective.
  • Evaluating the effectiveness of the SOP and the transfer to on the job behavior.
  • SOP maintenance - the good, the bad and the ugly.  How to get them right and keep them right!

If you are worried about drowning in a sea of badly written SOPs, this is your S.O.S. call, and your opportunity to take steps toward safe, useful and compliant Standard Operating Procedures.

Kristina Barkhouser
Kristina Barkhouser has over 20 years of experience in technical and interpersonal skills development, with a background in presentation skills and instructional design, QA, regulatory compliance, and active learning techniques. With nearly 10 years of direct training experience in the Pharmaceutical industry, she specializes in designing training to meet the needs of a variety of educational levels and learning styles, while ensuring regulatory compliance. Kristina has earned the American Society for Training and Development (ASTD) Certified Professional in Learning and Performance (CPLP®) credential and is a well respected speaker at events sponsored by GMPTEA, PDA, ISPE, DIA, ASTD and more!  Kristina has a talent for designing interactive learning experiences to improve employee effectiveness and increase organizational performance, as well as inspire other training professionals.