Overview
Almost every paragraph of the Quality System Regulation for medical devices says that manufacturers shall “establish” procedures. This webinar will cover the expectations of the word “establish” and how to meet those expectations. This webinar will help you establish procedures by writing 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. Professionally 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.
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. And inadequate SOPs will result in non-compliance with regulatory requirements. Poorly written SOPs can and do impact your business.
Learning Objectives
- Overview of the Regulations
- FDA Expectations
- Lessons Learned and Common Mistakes
- Best Practices
- Preparing for an FDA Inspection
Webinar Takeaway
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
- SOP outlines and formats
- Should, Shall, May, Do Not, Guidance
- Tips for complete and concise
- Using process maps to make procedures clear
- Using diagrams and visuals
- Mistake proofing concepts
- Maintaining and controlling SOPs
- Ensuring adequate training to your SOPs
- Best Practices
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
Faculty Susanne Manz
Consultant | Educator | Author
Baltimore City County, Maryland, United States
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 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 is a certified Master Black Belt in Lean Six Sigma. 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.