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

The Top 10 QMS and EHS Management Articles of 2011

[fa icon="calendar'] Thu, Dec 22, 2011 / by Tim Lozier

As 2011 comes to a close, I thought this would be a good time to take a look back on some of the most popular topics that have been written about in our humble blog.  That, and I'm one foot out the door, egg nog in hand, so...

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EHS Management Quality Management GFSI eMDR MedWatch ISO Standards 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

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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