5 Things the FDA must do for Food Safety Management in 2012

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

The title of this blog really should be "5 Things the FDA Probably Won't do for Food Safety Management in 2012."

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FDA Compliance GFSI Food and Beverage Safety

eMDR Final Rule Date Still Unknown, but Submissions are on the Rise

[fa icon="calendar'] Thu, Oct 06, 2011 / by Tim Lozier

I have to admit, I was hoping to post a blog today announcing the final rule date for the Electronic Medical Device Reporting (eMDR).  Sadly, after much calling, emailing and searching, I came up with, "We don't know - hopefully the end of 2011".  This would sound encouraging, except I've heard that story before. 

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FDA Compliance 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

Quality Management Seminar Wrap-Up: Risk and Harmonization , Part 1

[fa icon="calendar'] Mon, Apr 18, 2011 / by Tim Lozier

This past week, we finished up a in-depth seminar in New Jersey.  The seminar, focused in the Life Sciences market, touched on the concepts of Global Harmonization and Standardization.  It also had a focus on Risk mitigation in Quality Management systems.  Overall, the seminar went well - great turnout, great speakers (great food), and overall a great response. 

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Quality Management Enterprise Risk Management FDA Compliance

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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