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4 min reading time
A rather explosive conversation started in the group this week when @Richard Bollinger posted “FDA compliance crisis still a threat.”
His post, verbatim:
“New FDA data continues to show an industry in crisis. One third (1/3) of all site inspections still get CAPAs that are voluntary or official actions. This holds true going back to 2009. The percentage should decrease every year, heading for zero.
When I see bad numbers staying bad I suspect systemic flaws. So, I am starting a research campaign,” and you can participate in his seven-question poll at https://medgroup.biz/richards-poll.
The fireworks began with @Ginger Cantor’s comment, again, verbatim:
“Worked for a manager once who told me if you don’t get a Warning Letter every so often you are not taking enough risks.”
(Ginger clarified, this was never her position nor the philosophy of the company she was with at the time.)
So my questions for the week:
GOOD TIMING: CAPA WEBINAR NEXT TUESDAY
Register at https://medgroup.biz/capa (it’s free) and you’ll get the slides even if you can’t attend live.
As a bonus, all who attend the live event will get a $100 coupon off Jon Speer’s in-person workshop at the 10x Medical Device Conference in April (New Jersey). Learn more at https://medgroup.biz/10x.
FREE ADMISSION MONDAY JAN 8, 2018 at the Digital Medicine & Medtech Showcase.
This event takes place as part of the Biotech Showcase in San Francisco, during healthcare’s biggest week of the year. Monday’s program features a panel discussion, company presentations, and a networking reception.
For your free pass: https://medgroup.biz/digimed
Make it a great week.
Gabe Turner, MBA
Mark Proulx, CQA, cSSBB, MS-GSD
RAKESH SRIVASTAVA, CRC, MD
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