Medical Device 2020 - 10 facts about Secrets for Writing Excellent SOPs for Medical Device QMS Live Webinar

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
"Inadequate SOP" is still one of the most frequently citied observations in FDA 483 and Warning Letter observations. Additionally, inaccurate, incorrect SOPs can lead to severe consequences and quality problems for your customers.
FDA and NB expectations for SOPs
Lessons Learned from 483s and warning letters
Speaker:
Susanne Manz MBA, MBB, RAC, CQA is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma.