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Jeremiah Genest

@jeremiahgenest

Bostonian. Pharmaceutical QA. Worrier.

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Latest posts by Jeremiah Genest @jeremiahgenest

I always wonder if Luft and Ingham found as much humor in their matrix as many of us who use the concepts do. But this joke is beautiful

06.03.2026 02:49 👍 2 🔁 0 💬 0 📌 0
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Why We Must Fight to Stop HR 7661 Before It Destroys the Lives of American Children Lately I’ve been calling my House rep and screaming about one zillion things, and maybe you have too. But today I want to talk about one thing in particular you should add to your list: H.R. 7661 i…

I wrote about the first national book banning bill, which effectively seeks to erase trans people. At the end I include a link to let your reps know that you oppose this bill and all it stands for. lithub.com/why-we-must-...

05.03.2026 13:45 👍 642 🔁 440 💬 8 📌 12

For quality and systems folks, Laloux is a useful irritant. He asks what happens if you design everything—governance, HR, budgeting—to be congruent with your stated values, not just your latest continuous improvement project.

02.03.2026 02:34 👍 1 🔁 0 💬 3 📌 0

Frederic Laloux is interesting because he treats org design as an evolutionary question, not a reorg exercise. “Reinventing Organizations” asks: what structures become possible if we actually trust people and design for wholeness and purpose, not just control?

02.03.2026 02:32 👍 1 🔁 0 💬 0 📌 1
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Dear Raz: Building Technical Depth from a Compliance Foundation — A Certification Roadmap for Pharma Professionals A Reader Writes In A long-time reader of this blog, Raz, recently left a comment that I think resonates with a lot of people in our industry: “As a compliance lead with 10+ years of experienc…

investigationsquality.com/2026/03/01/d...

01.03.2026 16:34 👍 2 🔁 0 💬 0 📌 0

All three feel very compatible with Deming → Senge → Baldrige, but they force you to confront how messy the real system is.

01.03.2026 16:10 👍 1 🔁 0 💬 0 📌 0

Gerd Gigerenzer on heuristics and the “adaptive toolbox” in real decision-making

Amy Edmondson on psychological safety and failure as learning

Dave Snowden on complexity, sense-making, and why linear playbooks keep breaking in nonlinear systems

01.03.2026 16:10 👍 0 🔁 0 💬 1 📌 0

Love how you put that — the best frameworks surface how work actually flows instead of adding another layer of theater.

From the last decade, I’d add people pushing on uncertainty and learning:

01.03.2026 16:10 👍 0 🔁 0 💬 1 📌 0

Picking one more recent author from that list who leaders almost never actually read, I’d go with Gerd Gigerenzer. His work on heuristics and bounded rationality is a badly needed antidote to spreadsheet‑driven fantasy decision‑making.

01.03.2026 16:08 👍 3 🔁 0 💬 1 📌 0

Really appreciate this. That Deming → Senge line feels like one continuous argument about variation, learning, and responsibility that we’ve chopped into separate “methods.”

01.03.2026 16:08 👍 1 🔁 0 💬 1 📌 0

Totally agree — Deming→Senge is one continuous thread that gets treated like separate tribes. Most overdue to *really* read: Follett on power, Dewey on inquiry, Beer on viable systems. Schein on culture right after that. Who’s on your list?

01.03.2026 16:08 👍 1 🔁 0 💬 1 📌 0
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Campaign Design Night's Black Agents: Burn Stakes OK, last post for this series. Let's talk about the opening scenario and what it means to play Burn Stakes. I'm going to try to avoid scenar...

Trying very hard not to drop everything and spin up a Nights Black Agents Burn-mode mini-campaign about Dionysian, riot-stoking Maenad vamps and their broken ritual sites now. (karloff-shelf.blogspot.com/2026/02/camp...)

01.03.2026 16:01 👍 3 🔁 0 💬 0 📌 0
My dog Ollie, a black and tan colored beagle chihuahua mix, sniffing the ground next to an enormous snow bank in our front yard

My dog Ollie, a black and tan colored beagle chihuahua mix, sniffing the ground next to an enormous snow bank in our front yard

My dog Ollie, a black and tan colored beagle chihuahua mix, resting on our couch with his chin resting on a pillow

My dog Ollie, a black and tan colored beagle chihuahua mix, resting on our couch with his chin resting on a pillow

Took a photo of one of the snow banks in our front yard, with Ollie for scale. Then I took a photo of him napping, because it was cute

25.02.2026 18:46 👍 9 🔁 2 💬 0 📌 0
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Rokuro Pottery Custom ceramics creation and one time lessons

A link to Andrew’s website: rokuropottery.com He teaches classes, but he also sells his work, and is sometimes available for commissions

21.02.2026 19:38 👍 3 🔁 2 💬 0 📌 0
A round terracotta casserole dish with a wide mouth and narrow base, perfect for making cassoulet. It is glazed a mustard yellow with some lighter yellow. It has a spout in front, and handles on either side.

A round terracotta casserole dish with a wide mouth and narrow base, perfect for making cassoulet. It is glazed a mustard yellow with some lighter yellow. It has a spout in front, and handles on either side.

The same dish (A round terracotta casserole dish with a wide mouth and narrow base, perfect for making cassoulet. It is glazed a mustard yellow with some lighter yellow. It has a spout in front, and handles on either side.) as viewed from the side.

The same dish (A round terracotta casserole dish with a wide mouth and narrow base, perfect for making cassoulet. It is glazed a mustard yellow with some lighter yellow. It has a spout in front, and handles on either side.) as viewed from the side.

The same dish (A round terracotta casserole dish with a wide mouth and narrow base, perfect for making cassoulet. It is glazed a mustard yellow with some lighter yellow. It has a spout in front, and handles on either side.) as viewed from the top, so you can see the interior, which has irregular streaks of lighter color

The same dish (A round terracotta casserole dish with a wide mouth and narrow base, perfect for making cassoulet. It is glazed a mustard yellow with some lighter yellow. It has a spout in front, and handles on either side.) as viewed from the top, so you can see the interior, which has irregular streaks of lighter color

The same dish again (A round terracotta casserole dish with a wide mouth and narrow base, perfect for making cassoulet. It is glazed a mustard yellow with some lighter yellow. It has a spout in front, and handles on either side.) but a close up of one of the handles, next to an Imbolc oracle card called Casserole, which features an illustration of individual dishes of casserole

The same dish again (A round terracotta casserole dish with a wide mouth and narrow base, perfect for making cassoulet. It is glazed a mustard yellow with some lighter yellow. It has a spout in front, and handles on either side.) but a close up of one of the handles, next to an Imbolc oracle card called Casserole, which features an illustration of individual dishes of casserole

After making cassoulet and reading that it’s traditionally made in a clay pot, I had the brilliant idea to commission one from our pottery teacher, Andrew Jacoff of Rokuro Pottery! It’s frankly gorgeous, and I can’t wait to try it out in the oven!

21.02.2026 19:34 👍 43 🔁 6 💬 4 📌 0

Manufactured doubt on the safety of vaccines has led to trying to fast track a “study” in Guinea-Bissau “testing” their efficacy by depriving infants of access to the Hep B vaccine.

the Tuskegee experiment is not just a historical monstrosity, it’s a warning.

21.02.2026 14:24 👍 169 🔁 63 💬 3 📌 2
A red hand knit hat with a ribbed brim, pointed top, and a tassel.

A red hand knit hat with a ribbed brim, pointed top, and a tassel.

My husband (a white, middle aged man with greying hair and beard, and glasses) wearing the Melt the ICE hat. He’s also wearing a green sweater, so it looks rather Christmassy

My husband (a white, middle aged man with greying hair and beard, and glasses) wearing the Melt the ICE hat. He’s also wearing a green sweater, so it looks rather Christmassy

Started a Melt the ICE hat, then realized I had a book (Norwegian Handknits by Sue Flanders and Janine Kosel) with a pattern for Nisse hats, so this is kind of an amalgamation of the two. 🧶 Thanks to @jeremiahgenest.bsky.social for modeling

08.02.2026 15:20 👍 37 🔁 5 💬 0 📌 0
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Rumor: Are Margaret Qualley and Callum Turner the stars of Paramount's Possession remake? A rumor suggests that Margaret Qualley and Callum Turner could star in Parker Finn's remake of Andrzej Żuławski's Possession.

I love The Possession, it's an amazing movie. But I also think a remake is a bad idea. One can hit all the same themes without doing a 'remake' www.joblo.com/possession-m...

01.02.2026 17:07 👍 2 🔁 0 💬 0 📌 0
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A red hat, inspired by a symbol of resistance to Nazi occupation, gains traction in Minnesota A Minneapolis knitting shop has resurrected the design of a Norwegian cap worn to protest Nazi occupation. Its owner says the money raised from hat pattern sales will support the local immigrant commu...

There has been some discourse about performativity among people who don't appreciate the importance of aesthetics in social movements.

31.01.2026 21:51 👍 89 🔁 15 💬 4 📌 2

No need to imagine. The country incarcerates children as young as 9 years old daily in youth prisons and jails. Those children are routinely sexually and physically assaulted and also emotionally tortured. They are fed terrible food and given barely any education. This country has done this for yrs.

01.02.2026 02:23 👍 2784 🔁 896 💬 19 📌 0
BILLY BRAGG - CITY OF HEROES
BILLY BRAGG - CITY OF HEROES YouTube video by Billy Bragg

Bill Bragg continuing to demonstrate why I've listened to him for 4 decades youtu.be/IKOW2ZikGW8?...

31.01.2026 19:44 👍 2 🔁 0 💬 0 📌 0
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Why won’t anyone stop ICE from masking? Americans do not like masked secret police.

“The masks aren’t normal. Americans don’t like them. The fact that California’s attempt to ban them is in dicey legal territory is a strong indicator that things have gone seriously sideways.”

25.01.2026 15:56 👍 52 🔁 11 💬 2 📌 4

Katherine Eban is one of my favorite reporters. But then i’m a sucker for someone who makes such a big part of their reporting my industry

18.01.2026 16:36 👍 3 🔁 0 💬 0 📌 0

We all fell in love with cassoulet when we were in Toulouse so i’m very excited we are making out own

17.01.2026 15:09 👍 2 🔁 0 💬 0 📌 0
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2026’s New Horror Books All the new horror books coming in 2026, featuring all manner of hauntings, murderers, vampires, monsters, cults, ghosts, and all kinds of nebulous eldritch terrors.

2025 was a great year for horror fiction and 2026 is shaping up to top it! The 🧵 below lists my most anticipated books by authors of horror & weird lit, but MANY more are coming out this year! @emilyhughes.bsky.social maintains the master list at readjumpscares.com/2026-new-hor...

11.01.2026 00:14 👍 23 🔁 6 💬 1 📌 0
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Hundreds of Mysterious Victorian-Era Shoes Are Washing Up on a Beach in Wales. Nobody Knows Where They Came From The leading theory is that the black leather boots, which were discovered by volunteers, were traveling on a cargo ship that sank nearby roughly 150 years ago

www.smithsonianmag.com/smart-news/h...

10.01.2026 21:35 👍 2 🔁 1 💬 0 📌 0
Mentorship as Missing Infrastructure in Quality Culture The gap between quality-as-imagined and quality-as-done doesn't emerge from inadequate procedures or insufficient training budgets. It emerges from a fundamental failure to transfer the reasoning, judgment, and adaptive capacity that expert quality professionals deploy every day but rarely articulate explicitly. This knowledge—how to navigate the tension between regulatory compliance and operational reality, how to distinguish signal from noise in deviation trends, how to conduct investigations that identify causal mechanisms rather than document procedural failures—doesn't transmit effectively through classroom training or SOP review.

Mentorship as Missing Infrastructure in Quality Culture

The gap between quality-as-imagined and quality-as-done doesn't emerge from inadequate procedures or insufficient training budgets. It emerges from a fundamental failure to transfer the reasoning, judgment, and adaptive capacity that expert…

10.01.2026 15:28 👍 1 🔁 0 💬 0 📌 0
The Hidden Contamination Hazards: What the Catalent Warning Letter Reveals About Systemic Aseptic Processing Failures The November 2025 FDA Warning Letter to Catalent Indiana, LLC reads like an autopsy report—a detailed dissection of how contamination hazards aren't discovered but rather engineered into aseptic operations through a constellation of decisions that individually appear defensible yet collectively create what I've previously termed the "zemblanity field" in pharmaceutical quality. Section 2, addressing failures under 21 CFR 211.113(b), exposes contamination hazards that didn't emerge from random misfortune but from deliberate choices about decontamination strategies, sampling methodologies, intervention protocols, and investigation rigor.​

The Hidden Contamination Hazards: What the Catalent Warning Letter Reveals About Systemic Aseptic Processing Failures

The November 2025 FDA Warning Letter to Catalent Indiana, LLC reads like an autopsy report—a detailed dissection of how contamination hazards aren't discovered but rather…

09.01.2026 18:26 👍 1 🔁 1 💬 0 📌 0
FDA PreCheck and the Geography of Regulatory Trust On August 7, 2025, FDA Commissioner Marty Makary announced a program that, on its surface, appears to be a straightforward effort to strengthen domestic pharmaceutical manufacturing. The FDA PreCheck initiative promises "regulatory predictability" and "streamlined review" for companies building new U.S. drug manufacturing facilities. It arrives wrapped in the language of national security—reducing dependence on foreign manufacturing, securing critical supply chains, ensuring Americans have access to domestically-produced medicines.

FDA PreCheck and the Geography of Regulatory Trust

On August 7, 2025, FDA Commissioner Marty Makary announced a program that, on its surface, appears to be a straightforward effort to strengthen domestic pharmaceutical manufacturing. The FDA PreCheck initiative promises "regulatory predictability"…

08.01.2026 15:13 👍 1 🔁 0 💬 0 📌 0