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ComplianceQuest is the #1 AI-powered Quality, Risk, and Compliance (QRC) platform that connects Product, Quality, Manufacturing, People, Suppliers and Customers in a single system.
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If there’s one thing common across manufacturing industries that companies can agree on, they hate recalls.
There are so many internal quality, external market and unexpected supplier factors that can lead to the very difficult decision to pull back product from the market, or worse yet be told by the FDA to do so. A product recall is potentially the most risk-laden situation a company can face. At worst, recalled products are linked to injuries, illnesses and even deaths. For manufacturers, recalls batter brand reputations, bottom lines and share prices.
Yet businesses can often underestimate the impact of a recall, the negative effect it can have, and the great amount of money and resources needed to manage it. It’s backbreakingly hard work. So how do you avoid such a costly and disruptive situation within your own company? Knowledge is power. We will take a closer look at the latest FDA guidance and trends regarding these sometimes avoidable situations and review some of the best practices to help manage them.
The US FDA has retired its QSIT (Quality System Inspection Technique) requirements for medical devices…
Webinar Part 1 The regulatory foundation and rationale behind the QSMR role FAQs on QSMR…
FDA inspections aren't just routine checks – they're the linchpin of pharmaceutical success. FDA inspections directly impact public…
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