Secrets for Writing Excellent SOPs (Standard Operating Procedures)

01:00 PM ET | 10:00 AM PT | 12:00 PM CT Duration 90 Minutes

Webinar Includes : All the training handouts , certificate ,Q/A and 90 mins Live Webinar

" Susanne Manz MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma"

Structure your QMS and develop accurate

Description

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.

Why Should you Attend

"Inadequate SOP" is still one of the most frequently citied observations in FDA 483 and Warning Letter observations. Additionally, inaccurate, incorrect SOPs can lead to severe consequences and quality problems for your customers. This webinar will point out common errors in writing SOPs.

Areas Covered

This 90-minute webinar will focus on how to write clear, concise SOPs that your employees can follow. Topics to be covered include:

•     FDA and NB expectations for SOPs
•     Lessons Learned from 483s and warning letters
•     Common problems with SOPs
•     How to structure your QMS and SOPs
•     How to outline and format your SOPs
•     Using process maps to make procedures clear
•     Using diagrams and visuals
•     Maintaining and controlling SOPs
•     Ensuring adequate training to your SOPs
•     Best Practices

Who will Benefit

•     Understand QMS structure
•     Understand key elements of SOPs
•     Understand FDA expectations
•     Understand ways to make your SOPs more clear and easy to follow
•     Understand common problems and areas for improvement
•     Making your SOPs effective and efficient

Industries who can attend

•     Quality Systems Specialists
•     Document Control Specialists
•     Quality and Compliance Specialists
•     Internal Auditors and Managers
•     Training Specialists
•     CAPA Specialists
•     Supplier Quality Engineers and Auditors
•     Quality/Compliance managers or directors for Medical Device companies
•     General Managers wanting to learn how to understand Quality System requirements


Speaker Profile

Susanne Manz

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 is a Presidential Scholar and 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 is a Certified Quality Auditor by the American Society for Quality. She has also served as a judge for the ASQ ITEA awards. Susanne has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance. 

Specialties: Quality, Compliance, Six Sigma, Lean Sigma, Quality Systems Development, ISO13485, ISO14971, GMP, QSR, CFR820, Quality Systems Auditing, Supplier Audits, Due Diligence, Predictive Compliance,Training and Education, FDA and Notified Body Inspection Readiness, Risk Management and Mitigation, Management Review, Quality Improvement, Supplier Management, Supplier Auditing, Process Validation, Problem Resolution, 483 / Warning Letter responses and mitigation.

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