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 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 ...

OVERVIEW This webinar will detail a step-by-step procedure on how to prepare a standard operating procedure (SOP) that is a practical, effective and compliant. Also learn how to review and revise SOPs and maintain compliance over the course of the SOP life-time. WHY SHOULD YOU ATTEND A large number of FDA's inspectional observations can be traced back to deficiencies in SOPs at an organization. SOPs are often inadequate, miss important elements, lack tools to increase compliance with the SOPs and, often are hard for the employees to understand them. They are frequently poorly written, communicated, monitored and enforced. This webinar will provide guidelines on how to write standard operating procedures and work instructions for FDA-regulated organizations. You will become familiar with the basics of how to generate a great SOP How to remain compliant and yet not restrict the course of action How to maintain the compliance over the course of the ...