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:
• What do you think of Ginger’s old manager’s perspective on Warning Letters?
• Is there a viable business case to be made for it or is a “viable business case” beside the point?

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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.

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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

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Make it a great week.

Joe Hage
Medical Devices Group Leader

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Neil Thompson
Founder at Teach the Geek
Besides the cost of having to address warning letters, what other consequences are there? I can think of one: team morale and employee turnover. I doubt most people want to work for an organization that is known for receiving warning letters. Any other consequences to a laissez-faire attitude toward warning letters?

Julie Omohundro
Principal Consultant at Class Three, LLC
John Rohe, How do you see CAPA citations proving that? I don’t think they prove much of anything.

Julie Omohundro
Principal Consultant at Class Three, LLC
Gabe, how is it Ginger?

Dorothy Erlanger
Healthcare Industry Expert|Compliance Metrics Master|Meditation Teacher|Ironman Triathlete|International Speaker
One of Jon’s issues was ‘lack of cross functionality’, seeing CAPA as QA’s problem. Beyond that, a key problem is that each group involved is driven by different priorities and tends to see CAPA as a hold-back on achieving their specific goals.

Ginger Cantor
Founder/Principal Consultant at Centaur Consulting LLC
I agree how is it me? I didn’t agree with it! I found it quite alarming..

Gabe Turner, MBA
Contracts, Pricing & Compliance
It’s Ginger, her manager, but more importantly the senior management at the company. Isn’t that where the responsibility lies? What about those who maintain that compliance is an unnecessary expense? Are the messages coming from one voice? And, as far as messaging and performing, shouldn’t compliance be considered a cost of doing business or, better yet, a competitive advantage?

Mark Proulx, CQA, cSSBB, MS-GSD
Quality and Remediation Rock Star
Joe Hage as a Quality consultant, I have to call BS on Ginger’s manager’s comment. This is a traditional attitude I’ve seen rampant in the industry where managers put the bottom line above risk and quality. I’ve actually been party to medical device companies who get rid of the quality department citing “unnecessary expense.” I’ve also seen very compliant companies become very successful because they have all but eliminated CAPAs due to strict quality compliance and culture change. For the most part (and in my personal opinion), managers who would speak to it being normal to receive CAPAs, Warning Letters, 483s, etc. don’t understand the bigger macroeconomics picture even though they are talking bottom line thinking. If they only knew they could affect bottom line MORE by being compliant…

Robert Christensen
Medical Consultant
For your readers who wish to see what risk looks like, I think they would enjoy my book, David vs Goliath. I have attached a free link.

http://www.covenantmarriages.com/david-vs-goliath

Gary Chuven
Director of Regulatory Affairs at Cosmedent, Inc.
I would modify Ginger’s manager’s statement to refer to 483s, not Warning Letters. A Warning Letter indicates that you were given an opportunity to fix things, but did not do so to the Agency’s satisfaction.

Pinky Kirschner
Continual Improvements: Pharmaceuticals @ PharMEDium – an AmerisourceBergen company
Ginger’s old manager seems to believe that:
a. Taking bigger or more risks mean bigger rewards, and
b. Regulatory observations and warning letters are indications of taking risks
Healthcare laws are meant to protect public health. Regulatory observations or warning letters are indications that companies do not meet the laws. By implying that it is okay to break the laws that protect public health for greater reward is unethical if not criminal.
I am glad that I have not heard this argument before. I still have faith in humanity. Perhaps Ginger’s manager made that statement to justify a good rating for herself during a performance review which makes her very talented at turd polishing!

Gunther Reinhardt
Business Manager at Hearing Guard
Warning letters, if not constructive, then its time to move.

Ivan Liljegren
Director QA&RA at Breas Medical AB
Stupid thinking, as FDA CAPA are risk taking without reward. anyone who has done them know the significant additional cost of horizontal analysis (found issue w 1 product – need to check all similar products), formal correspondence, enforced timelines etc. Way less costly to comply.

John Rohe
(Marketing + Sales + Operations)Training = Commercialization Plus CLIA FDA CMS (Approvals, Clearances, Payments)
Solid companies don’t have to skate the edge. The rise of the non-technical CEO without technical Senior Management or frightened Senior Management has led to the situation we are in. CAPA citations prove it.

RAKESH SRIVASTAVA, CRC, MD
Clinical Researcher | Clinical Trials Manager | Apheresis | Immunology
Great education and device insight for CAPA.

Jeff Newcombe
General Manager at STERIS Instrument Management Services
Unfortunately you are assuming a completely consistent audit each time with no variation in auditor, auditor mindset or detail of regulation. Only if these hold true will you get the theoretical downward curve in CAPA .