Writing SOPs to Enhance Understanding and Compliance
Susanne Manz, MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with an emphasis on quality, compliance, and Six Sigma. She has worked at industry-leading companies such as GE, J&J, and Medtronic with an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. She is a Presidential Scholar with a BS in Biomedical Engineering and an MBA from the University of New Mexico. She earned her Black Belt and Master Black Belt certifications in Six Sigma while at Johnson and Johnson. Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and is a CQA (Certified Quality Auditor) 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.
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.
Almost every paragraph of the Quality System Regulation states that manufacturers shall “establish” procedures. This webinar will help you to write complete, clear, unambiguous, and flexible SOPs that accomplish that objective. You will learn techniques for creating concise and easy-to-read SOPs that your employees can understand and will follow. Well-written SOPs result in more consistent process output and quality results.
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.
- Overview of the Regulations
- How to “establish” procedures
- Lessons Learned and Common Mistakes
- Best Practices
- Preparing for an FDA Inspection
- FDA expectations for SOPs
- Lessons Learned from 483s and warning letters
- How to structure your QMS and SOPs
- How to outline and format your SOPs
- Use of Should, Shall, May, Do Not, Guidance
- 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
Course Level - Intermediate
Who Should Attend
- 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
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 an 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.