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Secrets for Writing Excellent SOPs (Standard Operating Procedures) Webinar  

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Online Compliance Panel   

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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, General Managers

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Seminar Summary:

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. (see full course description)

 

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Training Course Syllabus:


Secrets for Writing Excellent SOPs (Standard Operating Procedures)

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 will 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

Seminar Summary:

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. (see full course description)

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