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