Author: Jeremiah Genest

Quality professional with over 20 years of experience. Gamer and storyteller with forty years of practice.

Semantic Meaning

Over on Squire to Giants, Steve Schefer, writes about the semantic drift of the word triage in business talk.

What’s in a word? Triage…

I think it can be a really valuable exercise to consider, and align on semantic meaning of words, even words that may seem to everyone to mean one particular thing, and triage is a great example of that. When we spend time agonizing over words in documents, arguing about glossaries, what we are doing is aligning over semantic usage for terms that may have drifted a lot.

And don’t even get started on cultural appropriation of words.

The technical nature of our work means that semantic change, which is already a natural and inevitable process in language evolution, is going to happen. Words that we regularly use acquire new meanings or shift in their usage over time. Look what we’ve done to the poor word leverage or pipeline for just to examples.

Like data, we need word stewards, the keeper of the glossary. This role is in service to the process owners to enforce them agreeing on terms and using them the same way as possible. This is why I strongly believe in central glossaries. The dangers of not doing this can be impaired communication, with the message being lost or misinterpreted. And that leads to inefficiencies, and errors, and history has shown us those errors can get pretty significant.

    Photo by Leeloo The First on Pexels.com

    FDA Draft Guidance on “Considerations for Complying with 21 CFR 211.110”

    Usually I expect the FDA to publish some basic primer material as a webinar, so I was a little surprised when “Considerations for Complying With 21 CFR 211.110” was recently published as a draft. I’ve been rereading it, looking for what is actually worthy of a guidance here, and quite frankly, struggling.

    It literally is a refresher course on 21CFR211.110. Maybe I should read it as “No we were serious about ICH Q8 and critical quality attributes.” Or maybe it is just the result of one too many bad Type C meetings lately.

    Anyway, good refresher on product quality, in-process controls and samples. Still I think this would be better as a webinar with some graphics. Maybe I’ll better understand why this was published based on what sort of crazy comments are made and I can scratch my head and wonder what shenanigans some of these companies are up to.

    Understanding Policies

    The article “Research: Do New Hires Really Understand Your Policies?” by Rachel Schlund and Vanessa Bohns in HBR does a great job discussing consent that I think have real ramifications on GMP training, especially of the read-and-understood variety. Really gets me thinking on GxP orientation and the building of informed consent.

    GxP New Hire Orientation

    Building Effective Consent

    1. Transparent Communication

    Provide clear, detailed information about the why’s.

    2. Staged Introduction

    Instead of overwhelming new hires with all that GxP training at once, introduce them gradually over time. This approach gives employees the opportunity to digest and comprehend each requirement individually.

    3. Interactive Training Sessions

    Conduct engaging training sessions that explain the rationale behind each major requirement set and allow employees to ask questions and voice concerns.

    4. Regular Policy Reviews

    Implement periodic reviews with employees to ensure ongoing understanding and address any evolving concerns or questions.

    5. Clear Benefits Communication

    Explain the benefits of each requirement to the employee and the organization, helping new hires understand the value and purpose behind the requirements.

    Dangers of De-Regulation

    Nothing makes me decide someone is an unserious thinker than the line “There are too many regulations” when discussing drug development and manufacturing. Okay, which one? Point to me the regulation you want to get rid of? Because frankly they all exist mostly as reactions to the crap some corporation got up to.

    I am going to be honest. I don’t trust corporations to do the right thing. Otherwise we wouldn’t have problems like we see in OTC and consumer goods. Just look at this recent article on cancer causing shampoos, sunscreens and tampons. And that is the tip of the iceberg if you ask me. Don’t even get me started on the risks in generics coming from China and India. Or the mess that is the supplement industry.

    So definitely put me in the category of regulations are a good thing. Are some poorly written? Sure. Are there some that need updating? Definitely. But as a whole 21CFR chapter 1 is a pretty decent set of regulations (don’t ask me about the other chapters, I rarely use them). The European Eudralex, pretty straightforward (okay I would get rid of QPs and RPs and all the rest but that is a cultural thing).

    I personally think we don’t go far enough. I want to write the regulation that requires every c-suite in every pharma, med device, OTC, consumer goods, supplement and food company to do an intense reading of the Jungle and then quarterly restorative justice sessions with victims of badly executed decision making. I want to see a regulation makes executives and board members truly accountable. I want to stop reading horror stories and seeing recalls.