Training Doyens

OVERVIEW Almost every paragraph of the Quality System Regulation for medical devices says that manufacturers shall “establish” procedures. This webinar will help you to write complete, clear, unambiguous, and flexible SOPs (standard operating procedures) that accomplish that objective. You will learn techniques for creating concise and easy to read SOPs that your employees can understand and will follow. Well-written SOPs ensure consistent process output and quality results. Standard Operating Procedures (SOPs) are acritical 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. WHY SHOULD YOU ATTEND ...

Well-written SOPs send a message to the FDA and notified bodies that your Quality Management System (QMS) is complete, accurate, and followed and more importantly, it ensures that your personnel can consistently and accurately follow your processes, which results in correct outcomes and quality work. Our upcoming webinar discusses how to write complete, clear, unambiguous, and flexible SOPs that accomplish the objective and which your employees can understand and follow. The webinar covers the following key areas: ·          FDA expectations for SOPs and lessons learned from 483s and warning letters ·          Using process maps to make procedures clear, and mistake proofing concepts ·          Maintaining and controlling SOPs LEARNING OBJECTIVES • Overview of the regulations • FDA expectations • Lessons learned and common mistakes • SOP best pr...

OVERVIEW Almost every paragraph of the Quality System Regulation for medical devices says that manufacturers shall “establish” procedures. This webinar will help you to write complete, clear, unambiguous, and flexible SOPs (standard operating procedures) that accomplish that objective. You will learn techniques for creating concise and easy to read SOPs that your employees can understand and will follow. Well-written SOPs ensure consistent process output and quality results. 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. WHY SHOULD YOU ATTEND ...