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  • "Every 483 Observation Has A Training Component"

    “Every 483 observation has a training component.” Truer words have never been spoken—I only wish it was me who said them. An FDA inspector I heard at a conference almost 15 years ago made this statement, and it forever changed how I look at 483 observations. I’ll admit up front that I have a bias towards training—after all, it’s what I do.  Others don’t necessarily share that bias, being that often training isn’t done well, isn’t timely or effective, isn’t always meaningful. I’ve heard the arguments and can even agree with some of them. But let’s set that aside for now and look at what the inspector meant.

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EMC®  Documentum® Research And Development

EMC® Documentum® Research And Development

Streamlining the regulatory submission process is essential to getting products to market faster today. But you need to create, review and maintain essential submission-related documentation appropriately, even as regulatory rules and requirements vary and evolve by country and region. And if you’ve outsourced to contract research organizations (CROs), your submission process must enable reliable, seamless collaboration with these resources.

EZ BioPac™: Powder Transfer Process

EZ BioPac™: Powder Transfer Process

Advanced Powder Transfer for Media and Buffer preparation and Solids additions.

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