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2016 - Webinar on Writing Effective SOPs for Medical Device Quality Management Systems
Date2016-07-22
Deadline2016-07-22
VenueOnline, Canada 
KeywordsEffective SOPs; FDA Warning Letter observation; Medical Device QMS
Topics/Call fo Papers
Description :
The FDA expects Medical Device manufacturers to “establish and maintain procedures”. You will learn what this means and how to comply with expectations. This webinar will help you ensure that your SOPs (Standard Operating Procedures) are complete, concise, and easy to follow. Well written SOPs are can improve your quality and compliance results by being easier to read and follow consistently. Learn how to mistake-proof your procedures.
Standard Operating Procedures (SOPs) are a basic ingredient of an effective quality management system. Yet, “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 an inspection. Well written SOPs send a message that your QMS is complete, accurate, and constantly followed.
This webinar will help you to write clear, unambiguous, yet flexible SOPs. You will learn techniques for creating easy to read, clear, and concise SOPs that your employees can easily follow. Well written SOPs ensure that your employees understand and consistently follow processes.
Areas Covered in the Session :
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
Subject Matter Experts and others writing procedures
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
Directors, VPs, and others attending management review
The FDA expects Medical Device manufacturers to “establish and maintain procedures”. You will learn what this means and how to comply with expectations. This webinar will help you ensure that your SOPs (Standard Operating Procedures) are complete, concise, and easy to follow. Well written SOPs are can improve your quality and compliance results by being easier to read and follow consistently. Learn how to mistake-proof your procedures.
Standard Operating Procedures (SOPs) are a basic ingredient of an effective quality management system. Yet, “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 an inspection. Well written SOPs send a message that your QMS is complete, accurate, and constantly followed.
This webinar will help you to write clear, unambiguous, yet flexible SOPs. You will learn techniques for creating easy to read, clear, and concise SOPs that your employees can easily follow. Well written SOPs ensure that your employees understand and consistently follow processes.
Areas Covered in the Session :
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
Subject Matter Experts and others writing procedures
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
Directors, VPs, and others attending management review
Other CFPs
Last modified: 2016-07-04 18:14:01