Root cause and corrective and prevent actions (referred to as CAPAs) are widely used across all companies when investigating an excursion, be it for customer complaints, downtime studies, safety incidents, or many other improvement opportunities. We find that many of...
This webinar is hosted by FDA News and sponsored by ComplianceQuest. Our guest speaker, Tim Fischer has over 30 years’ experience in lab operations, manufacturing, auditing, implementing GMP quality systems, FDA/Supplier remediation and more. Joining Tim is...
This webinar about complaints management is presented by Deb Kacera with over 20 years’ experience in quality, post-market complaints, risk and compliance in the medical device and manufacturing industries. She is a recognized leader in FDAs eMDR program and was...
Join us to understand the regulations and expectation for complaint investigations and reporting and learn how to use next generation technology to automate the complaints management system end to end by enabling intelligent data driven quality, productivity, and...
Environment, Health & Safety (EHS) are subjects that have been in existence for a long time now; and have paved their entry into almost every organization – regardless of size, industry or geography. Traditionally, EHS management systems were designed to help...
Since the publication of EU MEDDEV 2.12-1, there should be no surprise that the vigilance requirements in the new EU MDR share a lot of similarities. However, there are a few important changes, not really new, but rather bringing the EU legislation up to date....
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