Who Will Benefit: This CD Webinar is a must-attend for medical device professionals, including: | Compliance officers | | QA/QC/RA | | Plant engineers | | Laboratory personnel | | Operations and Manufacturing | | General/corporate counsel | Course Description: If there’s a problem with a device, where do you draw the line between a routine servicing issue and a “risk to health” you must report to CDRH? With the FDA cracking down on so-called silent recalls, making the wrong decision can lead straight to 483s, warning letters and even product seizures. In fact, CDRH warns devicemakers that something as simple as sending out a patch to fix a software glitch can be viewed as a reportable event. If your medical device develops a problem, you need know how to determine if it’s a “risk to health” to avoid an already costly issue from escalating into a regulatory nightmare. Head off 483s, Warning Letters and Product Seizures Nearly every device maker eventually encounters a serious product problem — and FDA inspectors will be on the lookout for “silent recalls” as never before. View and listen to this CD Webinar with our quality and compliance expert and stay proactive, making good decisions as device problems arise and prepare effectively for FDA inspections. |