+1-800-385-1627
support@recordedwebinars.com
Writing Excellent SOPs
Lynn Fountain
Access Recorded Version
Unlimited Viewing Recorded Version for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
Support
Call : +1-800-385-1627
Mailto : support@recordedwebinars.com
Overview:
Almost every paragraph of the Quality System Regulation states that manufacturers shall "establish" procedures.
Well-written SOPs that are easy to understand and follow are necessary to accomplish that objective. Excellent SOPs need more than just subject matter.
This webinar will help you to write complete, clear, unambiguous, and flexible SOPs. You will learn techniques for creating concise and easy-to-read SOPs that your employees can understand and will follow. Well-written SOPs result in more consistent process outputs and quality results.
Standard Operating Procedures (SOPs) are a critical ingredient in an effective and efficient Quality Management System. SOPs are typically one of the first things an investigator asks for in an inspection. Well-written SOPs send a message to the FDA and Notified Bodies that your QMS is complete, accurate, and followed.
More importantly, well-written SOPs ensure that your personnel can consistently and accurately follow your processes resulting in correct outcomes, quality work, and predictable results.
Why you should Attend:
"Inadequate SOP" observations still rank among the most frequently cited 483 and Warning Letter observations. SOPs are one of the first things an auditor/ investigator will review during an inspection.
Most importantly, poorly written procedures make it difficult for your employees to understand and consistently follow procedures. This can lead to disastrous consequences including quality problems and even recalls.Poorly written SOPs can and do impact your business.
Areas Covered in the Session:
- FDA expectations for SOPs
- Lessons Learned from 483s and warning letters
- Common problems and mistakes
- How to structure your QMS and SOPs
- How to outline and format your SOPs
- Use of Should, Shall, May, Do Not, Guidance
- How to be complete and concise
- Using process maps to make procedures clear
- Using diagrams and visuals
- Mistake proofing
- Maintaining and controlling SOPs
- Ensuring adequate training to your SOPs
- Best Practices
Learning Objectives
- Understand applicable regulations
- How to "establish" procedures
- Hallmarks of an effective SOP
- Lessons Learned and Common Mistakes
- Best Practices
- Preparing for an FDA Inspection
Who Will Benefit:
- Quality Systems Specialists
- Document Control Specialists
- Quality and Compliance Specialists
- Internal Auditors and Managers
- Training Specialists
- CAPA Specialists
- Quality/Compliance managers or directors for Medical Device companies
- General Managers wanting to learn how to understand Quality System requirements
- Subject Matter Experts who write procedures
Speaker Profile
Lynn Fountain has over 35 years of experience spanning public accounting, corporate accounting and consulting. 20 years of her experience has been working in the areas of internal and external auditing. She is a subject matter expert in multiple fields including internal audit, ethics, fraud evaluations, Sarbanes-Oxley, enterprise risk management, governance, financial management and compliance.
Ms. Fountain has held two Chief Audit Executive positions for international companies. She was a member of the senior leadership team for Aquila Inc. in Kansas City, MO, until the sale of the utility in 2008. At Aquila, she was responsible for Internal Audit, Enterprise Risk Management and Sarbanes-Oxley. She was an integral member of the senior leadership team that effectively executed the sale of the utility. Upon the close of Aquila, Ms. Fountain engaged in her own consulting and training business.
During this time, she worked with several organizations to establish ERM, Sarbanes-Oxley and governance frameworks. In addition, she has developed and delivered leading edge training sessions on COSO, internal audit, ERM, accounting, leadership, governance, compliance and ethics.
In 2011, Ms. Fountain was the Chief Audit Executive for an international construction and engineering firm in Kansas City. In this role she was involved in the active investigation of a joint venture fraud. The investigation included work with the FBI and ultimately led to indictment of the perpetrators and recovery of $13M.
In 2012, Ms. Fountain returned to her consulting and training business. Along with her risk management, internal controls and financial accounting consulting work, she
delivers training for the American Institute of Certified Public Accountants, Institute of Internal Auditors, and multiple seminar and training groups.
Ms. Fountain is the author of two separate technical books released in 2015, The first entitled "Raise the Red Flag - The Internal Auditors Guide to Fraud Evaluations" was published by the Institute of Internal Auditors Research Foundation and released in April 2015. Her second book "Leading The Internal Audit Function" was released in October 2015 by Auerbach Publications. This book serves as the initial launch for a series of leading practice internal audit and information technology publications. Her third book entitled “Ethics and the Internal Auditor’s Dilemma” is expected to be out in the Fall 2016. In addition, Ms. Fountain is a frequent blogger on the LinkedIn platform and has also had numerous articles published in professional and technical publications. She is currently authoring a third technical book on Corporate Ethics and the Internal Auditors Challenge.
She has performed as an adjunct instructor for the School of Business for Grantham University and developed the first internal audit curriculum for the School of Business at the University of Kansas. Ms. Fountain obtained her BSBA from Pittsburg State University and her MBA from Washburn University in Kansas. She has her CGMA, CRMA credentials and CPA certificate (non-active).