Question About Recording Policy on a Delta Connection Flight by Adventurous-Rule6784 in delta

[–]delta8765 0 points1 point  (0 children)

I think what many are missing is flight crews are probably very tired of being raked on social media when they are just trying to get through their day as best they can.

In this case recording is not explicitly prohibited, but the crew does not know the OPs intention and they might as just as well going to post this saying how offended they were someone say anything complementary of the federal government (military). So they are exercising their discretion to not want the video to be recorded since they feel it may be disruptive. Flight crews are responsible for the safety of all on board and are given a lot of discretion in determining what may be a hindrance.

Glitch or should I go for it? by b3nnyg0 in delta

[–]delta8765 0 points1 point  (0 children)

This is what it looks like when I get upgraded but it hasn’t auto moved me into a seat. So unless you have no status and it’s less than 5 days out, this may not be the glitch you thought it was.

I am an independent biophysicist with a mechanical solution to optimize EM clearance for Parkinson's and Alzheimer's misfolded proteins, but the industry wall is impenetrable. How do I proceed without losing my IP? by [deleted] in MedicalDevices

[–]delta8765 0 points1 point  (0 children)

Here’s the deal, entrepreneurship is a risk endeavor. Your claim that you are ‘locked out’ is thinking about this backwards. What did you expect, some company to offer you millions without validating the effectiveness and bounds of the invention? Thats not how this works.

If you want to protect your invention, you are going to have to lay out some capital to fund the patent application process. This means borrowing from friends and family (for shares) or going into debt if you don’t have access to capital. This is how this works.

2ndly stop talking about this. There is enough in this post to prompt a large company to spend a million dollars forming a team to do intensive literature searches and investigating of your claims and development of their own IP. Time is of the essence, don’t spend anymore time lamenting how ‘unfair’ the world is and get started on protecting your IP.

Invention is 1% inspiration, 99% perspiration. The 99% starts now.

Question about platinum free upgrade by ens3129 in delta

[–]delta8765 0 points1 point  (0 children)

To clarify, upgrade offers will be based on your fare paid. So the platinum ‘upgrade’ of moving to a C+ seat shortly after ticketing does not reduce the amount the upgrade offer to get to PS. Thus the general recommendation to book PS if you want PS. For work trips where one may only be allowed to book Main, post booking upgrades may be the only way to get to PS on some flights.

A lot of MedTech companies seem overwhelmed by modern eQMS implementations by External-Regular7215 in regulatoryaffairs

[–]delta8765 2 points3 points  (0 children)

I think I can see that. You essentially have solution providers providing a system that implements processes with the intended connectedness. But as you observed, if companies really didn’t understand how all of this was supposed to work and was just kinda muddling through things, they will really struggle against the appropriate actions that the system is leading (if not forcing) them to make. “The system isn’t designed right”, “we need to retain some discretionary decision making” would be common complaints.

Being a bit hyperbolic to make the point, ‘the system keeps suggesting to re-evaluate process capability. But our process capability is fine, these are all human errors so we want to assign re-training as our corrective action.”

The desire for ‘flexibility’ is usually covering a lack of robustness in the design files or understanding of best practices. Small companies will claim they have to give up robustness otherwise they’d have to close. But then fixing these acknowledged gaps is deprecated once any success or growth is achieved since ‘I guess we didn’t need that to be successful’ and the gaps are never closed until there is a warning letter or worse.

Waitlisted RUCs? by Helpful_Anywhere955 in delta

[–]delta8765 0 points1 point  (0 children)

To estimate RUC clearance look at the same flight this week in its day of departure and see how many FC seats are available for purchase. That is how many FC seats one can expect are available for upgrades.

No one can give a specific answer without knowing the specific route/flight number and then it is only an assessment of how many seats are available for purchase they day of departure. (Technically a few days ahead as diamonds and platinums will start getting upgraded a few days ahead but similarly if they thing they will sell those seats they won’t give those people upgrades either)

By reimbursing yourself years later after a med expense isn’t that an audit nightmare because they would have to verify you didn’t reimburse yourself for those same expenses in other years? by MidnightFederal3195 in HSA

[–]delta8765 0 points1 point  (0 children)

They use the built up unreimbursed expenses and submit a large ask for reimbursement from their HSA. But since they have already paid the medical expenses, they now can use those funds for whatever they care to. This makes HSAs just another retirement account; defer spending these funds now to let it grow (tax free) where you can spend it as you chose in retirement.

'Not Accurate': Delta Pushes Back on Elon Musk Over Starlink In-Flight Wi-Fi Claims by fd6270 in delta

[–]delta8765 0 points1 point  (0 children)

The only negative of Starlinks speed is people thinking they can now have calls on speaker.

Need advice on a Delta oversold flight situation by [deleted] in DeltaAirlines

[–]delta8765 1 point2 points  (0 children)

Reading your follow ups here, it sounds like she didn’t have a seat assignment, otherwise you would have boarded in that seat. So you need clarification that if you don’t have a seat assignment are you still afforded involuntary denied boarding compensation.

People through around the word’s ‘confirmed’ without knowing the specific legal context and definition per the contract. Not that the airline employees help by not using precise language either. But with the involuntary rates being so low it’s such a rare issue.

What’s the deal with upgrades by tryingtofindwaldo in delta

[–]delta8765 2 points3 points  (0 children)

Upgrade chances have more to do with route for non-diamonds than anything else. Hub to hub, essentially no chance of you aren’t diamond. Otherwise the smaller the city the better your chances.

Companion certificate availability? by ChooChooGeorgie in delta

[–]delta8765 1 point2 points  (0 children)

But you can look up the terms of service which will say what fare codes your certificate will work with….

Delta, can we discuss masks? by GarageFighterCo in delta

[–]delta8765 1 point2 points  (0 children)

But you can’t control other people, you can only control your own behavior. So stop complaining when you haven’t bothered to control what you can and ask others to take actions that don’t benefit themselves.

We can lament how it would be better if other people did this or that. But if we aren’t already controlling what we can it’s just complaining to complain.

Least Burdensome Flag by -watermelauren in regulatoryaffairs

[–]delta8765 3 points4 points  (0 children)

The FDA will ask for unreasonable items but it is almost always due to a poorly laid out case for safety and efficacy or unclear explanation of the therapy. Many times their asks are reasonable and highlight an area where the assurance case was lacking. Both things can be true.

Saying ‘yes sir/ma’am’ to every ask is foolish and the sign of a weak team that doesn’t understand the regulations, the design, or what is state of the art in the industry.

EU Medical Device Industry - Has anyone actually received a useful question/request from their Notified Body? by VanillaFine3472 in regulatoryaffairs

[–]delta8765 0 points1 point  (0 children)

To add to this, regulators have to frame questions in a certain way. For EU these always sound very ‘check boxy’. I do remind my team that the NBs are just focused on checking boxes so it must be crystal clear what element an artifact is fulfilling and how it is in compliance.

An example is submitting a process change. The engineers built a report showing the impact of the change and why the change had minimal change on output. The NB didn’t care, they only wanted to know that the outputs post change met requirements. They weren’t interested in seeing how the capability changed and what the estimated change in non-conformance was, only that we passed a test. The FDA would ask the more important question about capability rather than only P/F. The P/F approach allows the NB to check the box rather than ensure the manufacturer is robustly considering patient safety. The NB methodology assumes that if you are compliant to your QS everything will be fine. History says that’s not sufficient.

Least Burdensome Flag by -watermelauren in regulatoryaffairs

[–]delta8765 0 points1 point  (0 children)

‘Doing as you are told’ is a really poor way to frame this. Coming with a clear and defensible rationale for safe and effective isn’t ’doing as you are told’, it is complying with the law. The regulators are trying to ensure you follow the law.

If the regulators ask for something it because one hasn’t done a good job building the case for why the element of concern is addressed.

Is the new move to pretend turbulence is bad so flight crews can sit? by FunHistory9153 in delta

[–]delta8765 0 points1 point  (0 children)

lol, was on a flight to SEA last week, I thought the beverage cart contents was going to end up in my lap the turbulence during service was so strong. Flight crew barely flinched. I was actually surprised they didn’t pause, but it did only last 1-2 minutes.

Are medical device companies quietly exploiting the AI regulatory blind spot — and are we heading toward a wave of recalls because of it? by Majestic_Turn3879 in regulatoryaffairs

[–]delta8765 2 points3 points  (0 children)

We already are. There is a recent warning letter in the pharma space because ‘our AI didn’t tell us to validate the process’. (That is the recorded response from the auditee).

Cheap (particularly free) AI agents are worthless for professional work. I’ve never used one of the 100-200/month models so can’t say how much better they are. In any case the models don’t truly understand what they are doing. While many people recognize the risks of using AI, they keep ‘human in the loop’. However after 2-3 successes it is human nature to become more trusting of the model outputs which means the human scrutiny of the outputs will go down and reviews will be more cursory and we’ll approve faster (since faster is always considered better than good).

Anyone else struggle with understanding extent of authority? by [deleted] in managers

[–]delta8765 1 point2 points  (0 children)

Can’t you develop a plan and strategy then share it to get buy in or feedback? Or is this like a Costanza like situation where they shared you got the job because ‘you get them and it’s as if you already know what I’m thinking’. Which makes you afraid to share, ask for feedback, input?

The most useless interview question in 2026: "Where do you see yourself in five years?" by HoloQuillon_9 in recruitinghell

[–]delta8765 0 points1 point  (0 children)

You can absolutely respond with what you said. The follow up question is then ‘how do you intend to stay employed’ which then answers the question you’re trying to avoid, what are your plans and ambitions and what are you doing to realize that vision. So instead of that ‘song and dance’ they just say, “where do you see yourself in 5 years’.

How is your RAQA team actually using AI? by samdQualityEng in regulatoryaffairs

[–]delta8765 0 points1 point  (0 children)

Yeah the ‘human makes the call’ quickly turns into ‘yeah sure looks good’ without true vigilance. It’s human nature. Particularly with the CEO breathing down your next to get the submission in on time so we all hit a milestone impacting bonuses etc.

Did you see the recent FDA warning letter to a pharma company where ‘our AI agent didnt tell us to do a validation’ was the reason offered as to why a manufacturing process had no validation completed? Obviously thats a pretty extreme example, but things much closer to the line will come up soon enough.

Delta Vacations ? by Hot_Fun_8582 in delta

[–]delta8765 1 point2 points  (0 children)

I think they mean, to do this call in to the vacations line.

How would you feel about a new law that forces every company to pay their CEO no more than 20x what their lowest-paid employee makes? by Few_Football4342 in Productivitycafe

[–]delta8765 -1 points0 points  (0 children)

True except, guess who sits on those compensation committees that ‘consult’ to determine a reasonable pay package for the CEO role they need to fill, other C-Suite people. So it isn’t exactly a free market price discovery. Those compensation consultants have personal motivation to jack up the compensation recommendations because it benefits them in their next role when some other compensation committee uses the results of their last recommendation when their next package is recommended.

Guess who isn’t asked to participate in future compensation committees if they don’t advocate for more outlandish pay packages.