When I left my position as global head of information quality at Lonza, one of the parting gifts from my team was a bottle of 25 years old Laphroaig Single Malt Scotch Whisky, a couple of Cuban Romeo…
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Career Announcement5 months ago
LinkedIn Content Strategy & Writing Style
Global Quality & CSV/C&Q/DI Leader | AI/ML Validation | Inspection Readiness | Data Integrity & Governance | OT Quality | GxP | Inspection Readiness | Pharma | Biotech.
1 person tracking this creator on ViralBrain
Kurt In Albon positions himself as a pragmatic guardian of patient safety at the high-stakes intersection of GxP compliance and AI/ML validation. His content strategy centers on demystifying complex regulatory shifts, such as the EU AI Act and Annex 22, while providing a grounded counter-narrative to tech-optimist "hype" that ignores fundamental quality principles. He is notable for his principled skepticism toward AI autonomy, frequently using FDA warning letters and industry case studies to argue that "human-in-the-loop" oversight is a moral necessity rather than a bureaucratic hurdle. By blending high-level leadership insights with a commitment to peer education and professional endorsements, he creates a unique value proposition of regulatory advocacy rooted in technical realism, making him a vital voice for biotech firms navigating digital transformation.
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When I left my position as global head of information quality at Lonza, one of the parting gifts from my team was a bottle of 25 years old Laphroaig Single Malt Scotch Whisky, a couple of Cuban Romeo…
In recent days, I've seen a spike in the number of posts expressing everything from surprise over self-assumed righteousness to genuine outrage, regarding the Purolea FDA Warning Letter. For those not…
And by "those who get their hands dirty" I mean the front-line folks, not actual dirty people ;-) But seriously, a well-written URS will save you time, money, and headaches. Thanks to BGO Software -…
This is old - very old. (Or if you believe FDA, it will be posted on 12th of August 20008 (sic, see below). But it is also fricking hilarious! While a little disgusting (I hope they had no customers…
It was great presenting to such an amazing audience and team. Thank you, BGO Software - the digital health lab for the opportunity!
🤖 Is AI quietly redefining quality in your organization? Many quality teams are adopting AI and automation faster than they’re able to govern them. Decisions scale, risks propagate, and accountabilit…
2.5 posts/week
Posts / Week
4
Total Posts Analyzed
MEDIUM
Posting Frequency
25.8%
Avg Engagement Rate
STABLE
Performance Trend
250
Avg Length (Words)
HIGH
Depth Level
ADVANCED
Expertise Level
8/10
Uniqueness Score
YES
Question Usage
0.8%
Response Rate
Writing style breakdown
<start of post>
Another day, another "revolutionary" AI tool claiming to bypass the need for human oversight in GxP.
Before you hit the 'buy' button, think again.
I've spent the last week reviewing the latest draft guidance, and the message from the regulators is loud and clear: technology is not a substitute for accountability. (For those not in the know, check out the recent updates to Annex 11).
Interestingly, the loudest voices complaining about "innovation being stifled" are often the ones who haven't actually read the requirements. My question is: Seriously? Do you really want to bet your manufacturing license on an LLM that thinks 2+2 is 5?
Because here is the reality: the agencies aren't trying to stop you from using AI. They are trying to stop you from being reckless. By insisting on the Human-In-The-Loop, they ensure that when the technology inevitably trips up, a person is there to catch the fall before it reaches the patient. (And trust me, it will trip up).
A really cool point: the most effective compliance strategies I'm seeing right now aren't using new, flashy tools. They are sticking to the fundamentals of Data Integrity and applying them to new tech.
To those who still think "the old rules don't apply to us", read Sarah Moeller's latest breakdown here: https://lnkd.in/example and then tell me how "stifled" you feel.
Stick to the basics. It's cheaper than a Warning Letter.
Highly recommended!
<end of post>
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