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How to write a blog every day–without getting lost.

I recently received a comment regarding one of my older posts. The person asked a question that has nothing to do with QA/RA, but I thought some of you might enjoy my response. Here are the question...

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What is the future of reprocessed, single-use devices?

In 1999 the FDA conducted a meeting to discuss reprocessing of single-use devices (SUDs). In August 2000, a guidance document was published to communicate the FDA’s enforcement policy for 3rd parties...

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GHTF Just Released New and Updated Documents

GHTF Just Released New & Updated Documents. Leonard Eisner recently posted these links to new guidance documents that were released on November 2, 2012 by GHTF. These are definitely worth reading...

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What really matters…A more important kind of New Year’s Resolution

I took a second tonight to check-up on my blogs to see if any of you had questions for me. To my delight, there was a great question–that will be the topic of the next posting. I also noticed that you...

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Where can I learn about this Quality Management System (QMS) stuff?

A blog follower from Jon Speer’s website, Creo Quality, recently sent me a message asking for sources of good guidance on this Quality Management System (QMS) Stuff. There are a bunch of links below...

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Great Instructors and the Power of a SNICKERS

I guess there are still some instructors out there that need to be reminded that we can all read the regulations on our own. We don’t need to pay $1,000+ per day in order to have someone read stuff for...

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FDA Approval is NOT a Coverage Guarantee

After years of product development and clinical studies, Eli Lilly has finally received US FDA approval for its Amyvid PET Scan Imaging Agent. Unfortunately, the regulatory approval fight has just...

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What should governments do when technology changes faster than regulations?

The original spark of of an idea for this posting came from an article I saw about a new Smartphone App to help people hail a taxi in NYC. This new App is illegal (of course). The argument goes that...

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Trying something new…

Typically I have more to say, but I thought I would send something a little shorter “into the void” today. I thought I would share a few links with you: 1. I read a short blog posting about the need to...

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Just finished my second webinar!

If you missed it, I am performing another one LIVE with FXConferences next Wednesday, November 28 @ 11:30am EST. You can register for it by clicking here. I will not be reading my slides or walking you...

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How do you shadow an auditor? Did you learn anything?

If you are shadowing, you are taking notes so you can discuss your observations with the person you are shadowing later. Somewhere in your procedure for “Quality Audits”, I’ll bet there is a section on...

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How to finish your audit schedule by December 31st

There are 34 days until the end of 2012. You have four supplier audits and three internal audits to complete. Of course all but two of these audits are overdue. What should you do? Well if I were...

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How do you audit for compliance with ISO 14971:2012?

Let’s say that you went ahead and purchased ISO 14971:2012, read Annex ZA, and you identified a couple of gaps in your procedure. After you revised your Risk Management Procedure to be compliant with...

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How do you prepare for ISO 13485 registration?

A LinkedIn connection of mine recently asked for sources of good guidance on ISO 13485 registration. I wrote a blog recently about Quality Management Systems in General, but I had trouble finding...

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Special Request for German-Speaking Supplier Quality Person

A friend of mine is looking for someone to work on a short-term project (i.e. – approx. 2 weeks). The person should be an experienced supplier quality engineer. The person must be fluent in German...

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How to recruit, hire and train an auditor

Part 1: Recruiting Stop begging people to help you audit. Learn how to recruit auditors more effectively. Nearly 100% of the people I train as auditors were not hired specifically to be auditors....

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How to recruit, hire and train an auditor

Part 2: Hiring If you are an audit program manager that is training a new auditor from another department, treat them like a new hire! Once you have identified someone that you want to “hire” as an...

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How to recruit, hire and train an auditor

Part 3: Training Passing a webinar on auditing does not make you competent. Does your company ask incoming inspectors to update CAD drawings when there is a design change? Of course not. Your company...

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3 Tools for Qualifying Suppliers

For every task you have a choice of tools that you can use. For qualifying your suppliers, are you using the right tools? It’s been three years, but I’m sure most of you will remember this performance…...

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Learn the Process Approach & How to Use Turtle Diagrams

Example of Turtle Diagram provided by Jan Roovers Checklists are great for making sure that all aspects of the regulations are covered, but is there a way to get more out of your audits? Imagine how...

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