Objectives of the Presentation:
- Understand QMS structure
- Understand key elements of SOPs
- Understand FDA expectations
- Understand ways to make your SOPs more clear and easy to follow
- Understand common problems and areas for improvement
- Making your SOPs effective and efficient
Why Should you Attend?
‘Inadequate SOP’ is still one of the most frequently citied observations in FDA 483 and Warning Letter observations. Additionally, inaccurate, incorrect SOPs can lead to severe consequences and quality problems for your customers. This webinar will point out common errors in writing SOPs.
This 90-minute webinar will focus on how to write clear, concise SOPs that your employees can follow.
Topics to be covered include:
- 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
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
- 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