At ComplianceQuest, we recently organized a webinar on – How Will FDA’s New Approach to CSV Make Implementations Easier? In this webinar, Tim Fischer of Great Solutions Inc., gave us a detailed perspective of why the FDA is moving to a risk-based approach for...
Personal Protective Equipment (PPE) is not a new term in many industries with high risk of hazards. In fact, OSHA has codified the standards for PPE in Title 29 of the Code of Federal Regulations (CFR), Part 1910 Subpart I, as part of the General Industry Standards...
Would you like to guess what was declared ‘word of the year’ in 2020? It’s an easy one! Okay, here you go. Merriam-Webster Dictionary announced ‘pandemic’ as the word of 2020. No surprises there! It has been one of the most challenging years for people, enterprises,...
With manufacturing and supply chain processes becoming more complex, critical aspects of a product are being outsourced to external global suppliers or product parts have become commodity purchases. It has become imperative that the quality of these products also meet...
The pandemic has accelerated the adoption of remote audits, even in highly regulated industries like manufacturing and medical devices. With the COVID-19 virus lurking around and a wide variety of disruptions affecting enterprises – the role of audits has become more...
I am lying here cooling off from the oven with my new companion Grace. We are both gingerbread ‘persons’ to be politically correct. I am George, and we were just freshly baked from the kitchen of Ms. Nickolas. And yes, we have gum drop buttons. So what does this have...
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