2019 - Secrets to Writing Effective SOPs for Medical Device QMS

Overview
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.
Why should you Attend
"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 and inspection. Most importantly, poorly written procedures make it difficult for your employees to understand and consistently follow procedures. This can lead to disastrous consequences including quality problems and even recalls. Poorly written SOPs can and do impact your business.
Areas Covered in the Session
FDA Expectations for SOPs
Lessons Learned from 483s and Warning Letters
Common Problems and Mistakes
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
Speaker Profile
Susanne Manz MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities.