FDA Compliance 2020 - Writing Excellent SOPs

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 and 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
Susanne Manz ,MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. While at GE, J&J, and Medtronic, Susanne worked in various world-wide roles including Executive Business Consultant, WW Director of Quality Engineering and, Design Quality, and Director of Corporate Compliance. Susanne has a BS in Biomedical Engineering and an MBA from the University of NM.