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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 (NBs) 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 structure your QMS and develop accurate, clear, unambiguous SOPs.

  • 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?

This 90-minute webinar will focus on how to write clear and concise SOPs that your employees can follow.

  • Understand QMS structure
  • Understand key elements of SOPs
  • Understand FDA expectations
  • Understand ways to make your SOPs clearer and easy to follow
  • Understand common problems and areas for improvement
  • Making your SOPs effective and efficient

  • Using process maps to make procedures clear
  • Using diagrams and visuals
  • Maintaining and controlling SOPs
  • Ensuring adequate training to your SOPs
  • Best practices

  • Quality systems specialists
  • Document control specialists
  • Quality and compliance specialists
  • Internal auditors and managers
  • Training specialists
  • CAPA specialists
  • Supplier quality engineers and auditors
  • Quality/compliance managers or directors for medical device companies

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.

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