Almost every paragraph of the Quality System Regulation states that manufacturers shall 'establish' procedures.
Well-written SOPs that are easy to understand and follow are necessary to accomplish that objective. Excellent SOPs need more than just subject matter.
This webinar will help you to write complete, clear, unambiguous, and flexible SOPs. 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 outputs 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, quality work, and predictable results.
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.
Well-written SOPs that are easy to understand and follow are necessary to accomplish that objective. Excellent SOPs need more than just subject matter.
This webinar will help you to write complete, clear, unambiguous, and flexible SOPs. 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 outputs 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, quality work, and predictable results.
Why you should 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.
Areas Covered in the Session:
- 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
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
Speaker
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.
