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Recent Posts by admin_cq

COMMUNITY: What does this mean to CQ?

comâ‹…muâ‹…niâ‹…ty [kuh-myoo-ni-tee]:

  1. a social group of any size whose members reside in a specific locality, share government, and often have a common cultural and historical heritage.
  2. a locality inhabited by such a group.
  3. a social, religious, occupational, or other group sharing common characteristics or interests and perceived or perceiving itself as distinct in some respect from the larger society within which is exists.
  4. a group of associated nations sharing common interests or a common heritage.
When we hear the term "COMMUNITY", we usually think about our city, town, or maybe our neighborhood. Community is important to the business world, although we rarely consider this notion. I'd like you to consider the role community could play for your business: httpv://www.youtube.com/watch?v=xr1WkANMkT4

Is Now A Good Time to Start A Business?

Last week, I attended the Indiana Biomedical Entrepreneur Network where we discussed whether the current economy provided a good platform for starting new businesses. There are definite strengths in starting a business, for example:
  • cost of doing business is lower in Indiana
  • the economy presents new opportunities to reset your priorities and gain access to new resources
  • the economy brings potential customers with new problems that need new solution

In reality, anyone can submit the necessary paperwork to "start" an Indiana business. In fact, there seems to be a direct relationship between business layoffs/cut backs and an influx of new start-ups. But, being out of work is not a good enough reason to start a business and starting a business is not the same as sustaining a business. As the stats for small...

FDA and Outsourcing

Outsourcing seems to be a popular topic these days for medical device companies. There are publications devoted to the topic. Outsourcing certainly has its place. A recent post at MD&DI reminds readers that FDA regulations apply to outsourcing relationships. This should come as no surprise. Companies need to properly evaluate, qualify, and monitor suppliers. Typically these activities should coincide with the risk the supplier represents. The concept of outsourcing certainly isn't new. However, many companies are outsourcing more and more. And the types of activities and services being outsourced today are activities and services that a company would have held tightly just a few years ago. An established medical device company likely is aware of supplier and purchasing controls and associated regulations. Chances are these companies have quality procedures in place too....

Survey Says . . .

Thanks to all 5/24 MWDG attendees for completing the questionaire. Some great feedback and comments! Here is the summary: Did the discussion activity meet your expectation?
  • Approval >80%
  • Comments include:
    • More interesting with Discussion Group [format].
    • Low expectations but was pleasantly surprised.
    • No but keep plugging away it's getting better.
  • Chair comments: Achieving this approval rating time and time again will definitely be a challenge. Expectations for June's meeting are higher. We will always have our work cut out for us.
Did you like the format of the MWDG?
  • Approval >80%
  • Comments include:
    • Way better than a lecture.
    • Could have covered more ground. Did not feel like we did much.
    • Focus too brief. Found this meeting (CAPA) still not as value added as I would like.
  • Chair comments: The format seems to be popular and a better way to engage and encourage discussion.
Was the facility and...

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