For a limited time only you can subscribe to all three device related inspection products for $1,297, a savings of over $1,700.
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The GMP Letter
For 30 years, devicemakers have relied on The GMP Letter for the latest on the FDA's interpretation and enforcement of cGMPs and the Quality Systems Regulation — information you need to stay in compliance. Each monthly issue brings you updates on the FDA’s approach to facility inspections, changes to the EU’s unannounced inspections and the latest on joint inspections in these and other jurisdictions. You’ll also get the latest on cybersecurity, recalls, CAPAs, MDR reporting and more. And you’ll get links to Form 483s, warning letters, closeout letters, FDA policy notices and other reports to ensure your quality assurance efforts are a success. Monthly, 12 issues/year
FDAnews Inspection Insider
FDAnews Inspection Insider includes weekly news analysis. Plus you'll get access to more than 30 on-demand presentations on inspection preparation, a vast library of more than 105 global inspections guidance documents, expert advice on all facets of inspections, and the peace of mind that comes with knowing you’ll never miss a key development in inspection prep again.
483sOnline.com483sOnline.com is your own personal pre-investigation intelligence tool that identifies exactly what investigators are focusing on before they show up at your facility. It is more than just a library of more than 4,400 Form 483s, it’s a tool you can use every day to help you stay in compliance with FDA regulations. You can search by: Keyword or phrase, date, company and investigator name. 483sOnline.com is available 24 hours a day and 365 days a year and unlike other services it is updated weekly.
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