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 and quality work. This webinar will help you structure your QMS and develop accurate, clear, unambiguous SOPs.
Almost every paragraph of the Quality System Regulation for medical devices says that manufacturers shall “establish” procedures. This webinar will help you establish procedures by writing 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. Professionally written SOPs result in more consistent process output and quality results.
Why should you 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. This webinar will point out common errors in writing SOPs.
This SOPs webinar can help companies use develop and implement SOPs that are a competitive strength in creating and maintaining an effective and efficient Quality System.Learning Objectives
Who will benefit?
This SOPs webcast will be of a valuable assistance to the below audience.
Writing Excellent Standard Operating Procedures (SOPs), Writing SOPs, FDA Expectations & Best practices for SOPs, Writing SOPs, Standard Operating Procedures, SOPs
Susanne Manz, MBA, MBB, RAC, CQA has a BS in Biomedical Engineering and an MBA from the University of NM. She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson. Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and Certified Quality Auditor (CQA) certification from the American Society for Quality. Susanne has now established a consulting business with a mission to provide services to help
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