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course topics, from R&D and clinical trials to manufacturing, global regulatory, and post-market concerns.

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instruction from the best Subject Matter Experts in pharma, biotech, and med device.

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content that provides you with practical solutions to the toughest challenges.

INTERACTIVE

features for the adult learner including polling, break-outs, and assessments.

LIFE SCIENCE TRAINING INSTITUTE

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INDUSTRY RESOURCES

10
Apr
Are You (Inadvertently) Teaching Your Personnel To NOT Think?

We control our processes through our SOPs, as we should. But where many of us have gone wrong is that we teach people to blindly follow the SOP.

Have we as an industry eroded — or worse, driven out — people’s ability and motivation to think?

Posted in: Training,
19
Sep
4 reasons your 510(k) submission will be rejected (and how to avoid them)

While a high percentage of FDA 510(k) submissions are rejected the first time (69%!), yours doesn’t have to be one of them.

Posted in: FDA,
Tags: 501(k), FDA,
01
Jul
Training Effectiveness – a Quality by Design Approach

Without an outcomes based approach where you are ensuring training effectiveness, your employees’ performance will continue to suffer and so will your quality.

Posted in: Training,
Tags: QbD,
26
May
FDA’S 3D printing draft guidance leaves much unresolved, even more unknown

An intro to the FDA’s new draft guidance for Technical Considerations for Additive Manufactured Devices.

Posted in: Device, FDA,
Tags: FDA, medical device,
15
Apr
Every 483 Observation Has a Training Component

Truer words have never been spoken—I only wish it was me who said them.

Posted in: FDA, Training,
Applying-Human-Performance-Models-In-FDA-Regulated-Environments
15
Apr
Applying Human Performance Models In FDA-Regulated Environments

This article will provide regulatory context, address confidentiality concerns, and walk through an application based on an actual FDA 483.

Posted in: FDA,
Tags: FDA,

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