Lean Pharma: Is Your Company Missing the Big Picture?

[fa icon="calendar'] Thu, Dec 03, 2015 / by Rachel Beavins Tracy

Lean Manufacturing, Six Sigma, Lean Sigma—all of these practices have the potential to create significant cost savings, increased efficiency and better performance overall. The problem is, many companies miss the big picture by focusing exclusively on elimination of waste, instead of examining how wasteful practices impact the bottom line.

So how can you tell if your company isn’t fully leveraging the power of Lean, and how can you tap into its full scope for better results? This post will talk about some of the areas companies commonly overlook, with tips on how to strengthen Lean practices in your organization.

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Pharmaceuticals Life Sciences

3 Reasons to Adopt Automated Validation in Quality Management Systems

[fa icon="calendar'] Wed, May 04, 2011 / by Tim Lozier

My daughter has been learning how to ride a bike for the past year.  She's actually become quite adept at it, and for someone who loves to cycle, I am certainly proud.  But there were certain obstacles to overcome to get to this point.  We started simply with the tricycle - learning to pedal.  Then we switched to a "run-bike" to help learn balance.  Now we are on a two-wheeled bike with training wheels, and slowly beginning to take the training wheels off.  With each step forward, my daughter expressed a certain degree of fear - "will I be able to do this?," she intimated. Once she made the leap to the next level, she realized how much easier biking can become.  Leaving the training wheels can be scary, but the freedom of two wheels is much better.

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Quality Management FDA Compliance Medical Devices Pharmaceuticals Validation

Quality Management Seminar Wrap-Up: Risk and Harmonization, Part 2

[fa icon="calendar'] Mon, Apr 25, 2011 / by Tim Lozier

In the last post, I began my in-depth retelling of EtQ's Life Sciences Seminar on Risk Mitigation and Global Harmonization in Quality Management Systems. Overall the seminar was a great success, and we managed to keep everyone's attention for a few hours.

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Quality Management Enterprise Risk Management FDA Compliance Medical Devices Pharmaceuticals

HACCP for Medical Device and Pharmaceuticals

[fa icon="calendar'] Mon, Dec 20, 2010 / by Tim Lozier

I recently was speaking to a group of folks on the different ways to mitigate risk.  While this may not seem like "exciting" dialogue, it actually provoked an interesting thought - while many organizations interpret Risk factors differently, it seems that from one industry to the next, they tend to use a singular method.  One group uses FMEA exclusively, another uses HFACS or some human error risk, another uses HACCP, and so forth.

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FDA Compliance Medical Devices Pharmaceuticals HACCP Life Sciences

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