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 to write clear, unambiguous, and flexible SOPs. You will learn techniques for creating easy to read, clear, and concise SOPs that your employees can easily follow. Well written SOPs ensure that your employees understand and consistently follow processes. Well written SOPs send a message that your QMS is complete, accurate, and followed.
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.
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
- Using Process Maps to Make Procedures Clear
- Using Diagrams and Visuals
- Maintaining and Controlling SOPs
- Ensuring Adequate Training to your SOPs
- Best Practices
President and Principal Consultant ,
Manz Consulting, Inc.
Susanne Manz 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 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.
- 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