Online Webinar 2019 - Secrets for Writing Excellent SOPs (Standard Operating Procedures) Live Webinar

Overview
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.
Session Highlights
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
Objectives of the Presentation
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
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.
Who will Benefit
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 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.
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 medical device companies achieve world-class quality and compliance.