Writing Effective SOPs (Standard Operating Procedures)
Duration : 90 Minutes
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. She has a BS in Biomedical Engineerin Read more
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.
Course Objectives:
• 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
Course Outline:
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
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
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
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
100% MONEY BACK GUARANTEED
Refund / Cancellation policyGet In Touch
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