Secrets for Writing Excellent SOPs (Standard Operating Procedures)

Duration: 90 Minutes
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 structure your QMS and develop accurate, clear, unambiguous SOPs.
Quality System Management
Instructor: Susanne Manz
Product ID: 501292
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.

Areas Covered
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
Who can Benefit
  • 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
$375
Recorded Session for one participant
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How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
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.
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