Write It Right – Well Written Procedures Are Essential For QMS Effectiveness
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 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 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.
The webinar will help you to write clear, unambiguous, and flexible SOPs. You will learn techniques for creating easy to read and understand SOPs that your employees can consistently follow.
Well written procedures are a critical ingredient in an effective and efficient quality management system. They are an essential part of meeting the regulatory requirement to “establish and maintain” a suitable and effective quality management system. SOPs are typically one of the first things an investigator asks for during an FDA inspection. Well written procedures send a message to the FDA and Notified Bodies that your QMS is complete, accurate, and establishes regulatory requirements. More importantly, well-written procedures are the very means to ensure that your personnel can accurately and consistently follow your processes resulting in correct outcomes and quality work.
- 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
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 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.