Write it Right - Excellent SOPs for Improved Quality and Compliance

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.

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.

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

Areas Covered in the Webinar:

This 90-minute webinar will include:

• 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

Frequently Asked Questions:

1. What is FDA’s Advice for SOP Distribution and Comprehension?
2. What happens to workers’ intrinsic task motivation and creativity when employees are required to follow SOPs in completing their tasks?

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

Susanne Manz
President and Principal Consultant, Manz Consulting Inc

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, Worldwide Director of Quality Engineering, Design Quality, and Director of Corporate Compliance. She has traveled extensively throughout the world helping companies understand and improve their Quality Management Systems. 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, Manz Consulting LLC, with a mission to provide services to help medical device companies achieve world-class quality and compliance.Susanne’s new book on Medical Device Quality Management Systems – Strategies and Techniques for Improved Efficiency and Effectiveness, is now available on Elsevier and Amazon.

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