Using Quality Management Software Tools to Manage Recalls

[fa icon="calendar'] Fri, Jul 13, 2012 / by Tim Lozier

There is a saying, “plan for the worst, and hope for the best." This is the general tone I always take when discussing Recall Management. Let's face it—no one likes talking about recalls; there is no positive side to recalls, and certainly no one "wins" when a product is recalled. This is a double whammy when you are a medical device manufacturer—not only are you recalling a defective product, but you are also facing regulatory scrutiny and potential customer endangerment. So when I speak about medical device recalls, many are apt to have a system in place to manage processes in the unfortunate event of a recall. The critical factor in this case is what system is best suited to effectively and efficiently manage the recall process?

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Quality Management FDA Compliance Medical Devices

Sneak Preview: Complaint Handling and the Risk-Based QMS - Seminar

[fa icon="calendar'] Thu, Apr 19, 2012 / by Tim Lozier

Next week (April 24, 2012 at 8:30am ET to be more specific) we will be hosting our 3rd Annual Life Science Seminar in lovely Waltham Woods in Waltham, MA (wicked lovely).  This will be our third year doing this great event, and with each year, we hope to provide a venue to learn and share about the various topics in the Life Science community.  This year we have speakers from EtQ, Kimberly-Clark Corporation, and Celgene Corporation.

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Quality Management FDA Compliance Medical Devices eMDR MedWatch 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

eMDR: Why Start Now, and How your QMS will Help

[fa icon="calendar'] Fri, Jul 02, 2010 / by Tim Lozier

In the past few weeks, I have seen some further interest in customers asking about eMDR (or as it's called now, MedWatchPlus).  This is not to say that they are ready to implement, they are just interested.  Which, over the past year, has been the case - "We're interested in eMDR, but we're just looking right now."  This is fine - it's not yet mandatory, and the general theme is that customers have so much on their plate right now, ANOTHER system is not going to make life easier.

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Quality Management FDA Compliance Medical Devices eMDR MedWatch MedWatch Plus

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