Writing Effective SOPs for Medical Device Quality Management Systems

The FDA expects Medical Device manufacturers to “establish and maintain procedures”. You will learn what this means and how to comply with expectations. This webinar will help you ensure that your SOPs (Standard Operating Procedures) are complete, concise, and easy to follow. Well written SOPs are can improve your quality and compliance results by being easier to read and follow consistently. Learn how to mistake-proof your procedures.

Standard Operating Procedures (SOPs) are a basic ingredient of an effective quality management system. Yet, “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. Well written SOPs send a message that your QMS is complete, accurate, and constantly followed.

This webinar will help you to write clear, unambiguous, yet 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.

Areas Covered in the Session : 

• FDA and NB expectations for SOPs
• Lessons Learned from 483s and warning letters
• Common problems with SOPs
• 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

Who Should Attend:

• Quality Systems Specialists
• Document Control Specialists
• Quality and Compliance Specialists
• Subject Matter Experts and others writing procedures
• Internal Auditors and Managers
• Training Specialists
• CAPA Specialists
• Supplier Quality Engineers and Auditors
• Quality/Compliance managers or directors for Medical Device companies
• General Managers wanting to learn how to understand Quality System requirements
• Directors, VPs, and others attending management review

Course Director: SUSANNE MANZ

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.