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Secrets to Writing Standard Operating Procedures (SOP's) - Write it Right for an Effective Quality Management System!

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Course Description:

         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.

         Almost every paragraph of the Quality System Regulation for medical devices says that manufacturers shall “establish” procedures. This webinar will help you establish procedures by writing complete, clear, unambiguous, and flexible SOPs. You will learn techniques for creating concise and easy to read SOPs that your employees can understand and will follow. Professionally written SOPs result in more consistent process output and quality results.

Why should you 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 and 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. This webinar will point out common errors in writing SOPs.

         This SOPs webinar can help companies use develop and implement SOPs that are a competitive strength in creating and maintaining an effective and efficient Quality System.

Learning Objectives

  • • Overview of the Regulations
  • • FDA Expectations
  • • Lessons Learned and Common Mistakes
  • • Best Practices
  • • Preparing for an FDA Inspection

Areas Covered:

This 90-minute webinar on SOPs 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?
  • SOP outlines and formats
  • Should, Shall, May, Do Not, Guidance
  • Tips for complete and concise
  • Using process maps to make procedures clear
  • Using diagrams and visuals
  • Mistake proofing concepts
  • Maintaining and controlling SOPs
  • Ensuring adequate training to your SOPs
  • Best Practices

Who will benefit?

         This SOPs webcast will be of a valuable assistance to the below audience.

  • 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
  • Subject Matter Experts who write procedures

Registration Options



Max 5 participants from a single location with 1 Dial-in.


Max 10 participants from a single location with 2 Dial-in.


Avail 12 months unlimited access for a single user.


Material shipped within 15 days post webinar completion & get life time access for unlimited participants.



Avail recording + Attend live session for a single participant.


Unlimited participants for max 5 locations.


Tags


Writing Excellent Standard Operating Procedures (SOPs), Writing SOPs, FDA Expectations & Best practices for SOPs, Writing SOPs, Standard Operating Procedures, SOPs

Speaker Details

Susanne Manz

Susanne Manz

Medical Device Consultant

Susanne Manz, MBA, MBB, RAC, CQA 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

Refund Policy



Participants/Registrants for our live events, may cancel up to 72 hours prior to the start of the live session and ComplianceTrain will issue a letter of credit to be used towards any of ComplianceTrain's future events. The letter of credit will be valid for 12 months.

ComplianceTrain will process refund in cases where the event has been cancelled and is not rescheduled within 90 days from the original scheduled date of the webinar. In case if a live webinar is cancelled, participants/registrants may choose between recorded version of the course or a refund. Refunds will not be processed to participants who do not show up for the webinar. A webinar may be cancelled due to unavoidable circumstances, participants will be notified 24 hours before the scheduled start of the event. Contact us via email: admin@ComplianceTrain.com