#CFR events

[togetherness23]

ok so railways can choose to straight up not replace an engine with another engine w/the former’s number… cool. cool. very calm and rational about this.

[darkmaga-returns]

WHAT RULES ARE THESE THEN?

In the EU, they are known as Rules and Guidance for Pharmaceutical Manufacturers and Distributors 2017 (The Orange Guide). The equivalent in the US is the Code of Federal Regulations, Title 21, otherwise referred to as 21 CFR.

They have been in place for decades, and have become increasingly stringent as incidents have occurred in the supply chain to threaten the safety of patients. In 2007, one such incident occurred, resulting in death and serious adverse events, see below:

Inside Pharma

PHARMACEUTICAL SUPPLY CHAINS IN THE NEWS, FOR THE WRONG REASONS

THE HEPARIN TRAGEDY In 2007/8, pharmaceutical supply chains became the subject of global debate among key stakeholders, but for the wrong reasons. A tragic event occurred that shocked the world into realizing that pharmaceutical supply chains had the potential to kill and maim unsuspecting patients…

Read more

3 years ago · 2 likes · Hedley Rees

This tragic incident lead to legislation being passed on either side of the pond. In the EU, it was the Falsified Medicines Directive, 2011. In the US it was the Drug Supply Chain Security Act (DSCSA), 2013.

The aim of the legislation was to prevent such an incident ever happening again.

RULES IN THE ORANGE GUIDE WERE TIGHTENED TOO

In the EU, major changes were also made to the Orange Guide, Chapter 5: PRODUCTION.

This was to protect patients further, by placing obligations on companies manufacturing medicines to trace right back to the upstream sources of all materials used, to ensure they were genuine. The obligations also required traceability records to be kept, and audits carried out to ensure those companies were working to the regulations.

LEGISLATION DID NOT GO FAR ENOUGH

Unfortunately, as the legislation passed (for a number of reasons we can’t go into here) it only applied, and still does, to finished products as they travel from the finished product manufacturer to wholesalers and pharmacies.

Prevention of upstream adulteration, as per heparin, is dependent on manufacturers complying with the Orange Guide, Chapter 5 provisions.

TRUST ME, THEY COULD NEVER HAVE DONE THAT!

The thing to remember is that Good Manufacturing Practice (cGMP) applies to clinical trials, as well as commercial supply. It would have to, wouldn’t it, as the drugs are being tested on humans.

I would have more chance of climbing Everest naked (not a pretty sight!) than the manufacturers would have had in securing full traceability AND applying the cGMP rules for clinical trial supplies.

Something for medical freedom fighters to ponder, questions welcome :)

Hedley

[plethoraworldatlas]

Current state of Vote Uncommitted

(Linked for data)

Only a few states have yet to hold primaries.

As of now, according to this data, over 794 Thousand primary votes have been uncommitted/uninstructed/none/etc

+794,000

+794k

And this isn't even counting all the people in states that lacked uncommitted options and had to vote write in, or vote for some random other democrat in protest, or left blank, etc. Since so many of those are also protest votes in line with vote uncommitted, I would add another 100-150k to the amount of protest votes Vote uncommitted has gotten so far.

The largest amounts of uncommitted votes are in crucial swing states, by margins that far exceed the tiny amount Biden won by in 2020.

And remember, these numbers are just people who go out to vote in primaries; It takes effort to do that.

Almost 4/5ths of a million Primary voting Democrats have gone out to tell Biden

1) fuck you

2) we are against your genocide

3) our votes for you are dependent on you changing course now and totally

4) We do not have faith in your ability to win while doing this and attacking your own supporters, so stop and change course now

And this is just the vote uncommitted campaign; There are also the many, many, many major dedicated lifelong democrat donors and fundraising organizations that have signed letters and statements telling him to change course because they either can't support this genocide or they know this will cost him the election if he doesn't change course now, as well as those who have cut of funding for the same reasons, and those who did both and more.

here's a fun little quote to keep in mind

When you look at the smallest popular vote shift needed to give Trump a victory, the 2020 election was close. Indeed, it was even closer than 2016. If Trump picked up the right mix of 42,921 votes in Arizona (10,457), Georgia (11,779), and Wisconsin (20,682), the Electoral College would have been tied at 269 all. The House would have then decided the election. Republicans will hold the majority of state delegations in the new Congress, and they undoubtedly would have chosen Trump. If Trump had also picked up the one electoral vote in Nebraska’s Second Congressional District, which he lost to Biden by 22,091 votes, he would have won the Electoral College outright.  -CFR

[thatscarletflycatcher]

(Disclaimer yes yes I have been reading Gaskell + MacIntyre too much for too long and too consistently, yada, yada)

The whole context and discourse surrounding the shooting of the United Healthcare CEO encapsulates so much of the issues of Morality as the morality of current western societies, it fascinates me.

MacIntyre has been arguing for several decades now that Morality, that is, the common basis of general moral rules and forms of moral reasoning that are treated as natural and self-evident in our context, are a Frankenstein of simplified Kantism and simplified Utilitarianism. This event illustrates this to a T because it highlights one of its points of collision. "There are actions that are strictly forbidden without exception and regardless of circumstances" and "the maximization of happiness for the biggest number of people is a primary principle of action" coexist uneasily in every day life, but stick out sharply in this situation. "Murder is always wrong and unjustifiable" and "the killing of a murderer as an attempt to reduce deadly harm by way of intimidation is a justifiable action" seem almost like textbook illustrations of those general systems of ethics.

The similarities between the current case and the plot of Gaskell's Mary Barton, on the other hand illustrate what has fascinated me about Gaskell's moral vision ever since I started reading her. She, like us, lives in the world of Morality. Mary Barton could have been a novel about the moral dilemma that the murder of Carson Jr. presents in isolation. But for Gaskell, the first error in the moral appraisal of such a situation (as would have been the murder of Thomas Ashton) is precisely that framing of the moral reasoning.

In Mary Barton Gaskell is interested in knowing what leads a man to murder another man, and in consequence presents a diagnosis of a diseased community in which greed (what MacIntyre in the Aristotelian tradition calls pleonexia, acquisitiveness) reigns supreme and all lines of dialogue in pursuit of the common good are broken down. The murder becomes an inevitability; the structure of sin breeds the personal sin (this is an idea that shows up again in the French Revolution chapters of My Lady Ludlow).

She's also interested in the "what now?". In Carson and John Barton's reconciliation, Gaskell essays a first answer of a theme that will recur later on in, for example, North and South, which is the recognition of the humanity of the other. Both men have lost their sons; Barton lost his to the actions of Carson's class, and Carson lost his to Barton's hand. They are identified in pain and grief and so humanized, and this humanization brings some modicum of hope for the future because it reopens in some way the conversation about the common good that is to be achieved by all humans in communities.

The sad implication here for the real life situation we are witnessing, is in the doubling down of the dehumanization of the other, more violently and more spitefully done by the side that has in its hands the power and money to control the media intended to shape public opinion. As the plea "he was a husband and a father too" is responded with what boils down to "why should I humanize someone who refused to humanize me and/or those who are like me?", the first side responds by doubling down in the dehumanization of both shooter (cfr. attempts to paint him as irrational, delusional, etc) and the people whose plight he meant to channel (the new CEO of United Healthcare declaring that the company seeks to reject even more claims in future), circling back and ending with the full blast celebration and exaltation of pleonexia in an op-ed that proposes and defends that Brian Thompson is actually the working class hero, the role model to be followed.

The picture this paints for the future, if MacIntyre and Gaskell are right, is bleak.

[ericleo108]

FarmingHumans.com 2023 American Inequality

05/19/2023 Click here for Spotify, Apple Music, or Youtube. “American Inequality” is my 44th official release. This song is edutainment, or educational entertainment which is music that teaches you. The song is intellectual rap about American economic inequality. The song was self-recorded, and mixed and mastered by Keyano. The beat is from Tantu, and the cover art is made by ArtworkGang from Fiverr.

Links:

FarmingHumans.com YouTube Shorts Playlist

2022 American Inequality YouTube video blog post monologue

2022 American Inequality Blog Post 

“American Inequality” rap song

“Had Enough” rap song

“The Villian” rap song

Intro

I made a post about American inequality last year and the blog post for it on EricLeo108.com was the demo of this song and then a treatise about the problem. I planned on updating it every year I’m in graduate school or write a book with the original post’s themes. You can find the latest edition of my take on American Inequality at FarmingHumans.com or click here for the 2022 edition.

This (release) is the 2023 edition. Since I’m not in graduate school yet I haven’t added much to the plot/details but the concept is still there. This will be an abridged version with new revelations. I will discuss the main points of the American Inequality 2022 post and give an explanation that will clarify the lyrics. The video shown immediately below is the FarmingHumsns.com 2023 American Inequality 2023 monologue

YouTube Shorts

You can get the information presented here through shortform video from various creators by watching my “FarmingHumans.com” YouTube shorts playlist which will better detail and explain the information presented here. Most of the points I make here and reference can be found and enunciated in the YouTube playlist. 

Qualifications 

Why should you listen to me? I graduated magna cum laude with a degree in sociology from Eastern Michigan University. I took a class and received an A in college on a course about writing history. I keep up with current events and I have a reputation to build and uphold. Even if I don’t make it to graduate school this year, I’ll keep trying and I need to stay correct, intuitive, and current to make an impression in academia. I really can’t wait to apply sociological theory to the issues I discuss here. I have been accepted to a masters program in sociology at Western, but it’s still unknown whether I’ll be able to afford to attend seeing as I don’t have housing and I need to be awarded my fasfa which hasn’t come in yet. I also self-published my book “108 The Story of Discovering Earth’s Consciousness” which is non-fiction and autobiographical.

Who Rules America?

First of all, have you ever wondered “Who rules America?” Well, that very question is answered by William G. Domhoff a leading social structure sociological researcher at the University of California Santa Cruz. His experience and conclusions are more valuable than mine and worth looking into. But to summarize, corporations rule. To be more specific, corporate CEOs wield immense power. I say it best in my song “Had Enough,” it’s a “CEO fraternity, the CFR (council on foreign relations) logistically.” Although America is a democratic republic it functions as an oligarchy where a group of wealthy individuals rule.

Basically how our government functions is a coporporation wants something done so they fund a politician and write bills. Those politicians are then sympathetic to corporate wishes because that’s where there donations and livelihood comes from. The corporation then writes a bill that is presented by their politician, they fund a public relations campaign to get support, and if it doesn’t work the first ten times, they’ll keep trying until they succeed.

Sure special interest groups and communities do get laws passed, but this is the exception and not the rule. If you look at 2022’s post you’ll find a graph showing the average individual, economic elites, and interests groups effectiveness on government policy. The average individual have a flat effect where the wealthy and special interest groups have kind of a linear effect where the more support you have the more likely it is to get passed. Like George Carlin said, it’s a group of powerful individuals working in their self interest which creates a conspiracy of interests. Adam Conover discusses this in his content talking about corporate consolidation and the power it gives to inidividual CEOs. 

It seems that the effects of corporate consolidation are being recognized, thwarted, and attacked. This can be seen with the protests in France right now which are happening because their government wanted to raise the retirement age. The French people have taken to ransaking Blackrock’s headquarters in France because the people are saying they are responsible for the policy change. Blackrock and Vanguard are the largest corporations in the world. 

Buckley v. Valeo

Ever since the court decision Buckley v. Valeo wages haven’t kept up with productivity and the minimum wage has remained stagnant while costs have skyrocketed. To recap, America is so entrenched in corporate rule healthcare is privatized and we spend ⅕ of all spending on defense because it makes corporations a whole lot of money. Corporations and the wealthy can buy elections because money is speech. There’s a direct relationship between how much marketing a candidate does and their likelihood for winning. Those that can pay to familirarize themselves with the public win, and corporations have the money to make that connection between the politician and the voter happen. Read Noam Chomsky’s “Manufacturing Consent” for more. 

Socialism 

Capitalist have to blame socialism for economic problems because recognizing how capitalism really functions would show it’s flawed, based on luck and inherited wealth, and not based on merit. Socialism is simple, it’s “workers right over production,” which capitalist snear at because it mimimizes their control and importance. Capitlaist claim it’s the poor who don’t work hard but it’s the exact opposite that is true. The wealthy don’t have to work period, let alone hard. All you have to do is make wise decisions with your money; and by that I’m mean decisions that will make you more money. Like I say in my song “The Villian” they “claim it’s hard work when it’s leverage and a mindset.”

This can be seen with Marx’s “surplus value.” For a business to work you need labor and capital. The capitalist purchases the labor and capital goods (i.e. employees to run the machines). The money the business makes minus labor and the cost of goods goes to the owner, that’s called surplus value, and the owner does not have to work for it, all he needs is money to buy the labor and capital goods.

If you watch a season of shark tank you’ll see how the capitalist really think and act. They say all the time “I make my money work for me,” because the truth is you don’t get wealthy from working. You can get rich from you’re labor, but Elon Musk and Jeff Bezos didn’t get where they are through “earned income.” They made their money through captial gains which the American government literally calls unearned income. You work to make a living, and America doesn’t have a labor shortage, it has a living wage shortage.

Real Capitalism 

Capitalist have to say that it’s socialism because otherwise it’s the reality that it’s the current capitalist system that doesn’t allow the individual to live (let alone thrive) and creates rampant inequality. The truth is from Adam West to Mark Cuban (as you will find in the Youtube shorts playlist) the reality is capitalism requires government intervention from wealth becoming too consolidated. 

It’s literally the job of the government to break up monopolies, and raise the minimum wage. But things like that don’t happen, and capitalism goes unchecked and out of control because corporations can basically control the government through lobbying and because money is speech. This is why we desperately need to get money out of politics. There’s hope, for example, AOC has recently introduced a bill to prevent congress from trading stocks.

The truth is what the right and Fox News calls socialism is really the opposite of what it means. First of all, they think socialism is giving poor people money, which it isn’t, it’s workers rights over production. As MLK said "This country has socialism for the rich, and rugged individualism for the poor.” And by the right’s explanation of socialism, giving money to the entitled, corporations and the wealthy are socialists. You the taxpayer, give way more to corporations in taxes than any wealthfare program. If this country want’s to be in a rage about people getting money that they don’t deserve and feel entitled, you should be mad about corporate welfare (which is considered socialism by the right’s wrong definition).

Corporate Rule: Examples and Results

Some examples of the result of corporate rule are human rights around abortion (otherwise known as women’s healthcare) and gun laws. It’s clear we have such a problem with mass shootings because America is a militaristic nation and the gun manufatures (again) want to make more money so they have lobbied the government through the NRA to make guns so available they are the leading cause of death in children. 

Another example is the East Palestine Ohio train derailment. The truth is this is endemic to the way the industry works. The union tried to warn Norfok Southern and other train companies that rails were unsafe and suggested new rail and braking system. Norfolk never upgrade their breaks or rails resulting in the derailment due to negligence because they were trying to cut costs. Again, this is what every corporation does, it’s to make the surplus value for the shareholders. And again with the conspiracy, working in their own self interests to make more money a train corporation has caused a enviromental disaster, just like working in their self interests corporations have created economic despotism in America.

White Nationalism

Leaning into the conspiracy aspect and how self-interested groups merge to serve their self interests, there is a very real christian white nationalist agenda in the Republican party because corporate rule has becomed so powerful and unhinged. If you’re looking for me to point fingers at who are the conspirators, look no future than the Alliance Defending Freedom (ADF) and the Council for National Policy (CNP). These organization have ideals that many corporations support because it gives them more power. The ADF and CNP are responsible for propagating hate through society and the government with banning books, attack on women’s healthcare and reproductive rights, and the current genicide against the transgendered. Look to the Youtube Shorts Playlist for more information.

Personal

In this “American Inequality” song I say “The government exploits my labor power for healthcare” because I’m only allowed around $800 in earned income per month before I go into a trial work period which could cause me to loose my healthcare. That’s not labor exploitation but rather labor-power exploitation. The government is literally limiting me being able to leverage my labor power to create economic prosperity for healthcare. 

To explain further, the government sees income in two categories: “earned income” from employment or contract or “unearned income” from capital gains, profits, or royalties. I can make unlimited unearned income but only $800 per month from earned. Although I live on disability I got a job for a year for the seed money to start my music business.

I’m glad the system is the way it is with unlimited unearned income, but it should be better, it should be unlnimited earned income as well. It’s almost designed so you have to have money to make it out of poverty. You won’t get on the disability system in the first place unless your economically depraved. And you can only use your labor to make so much money. This is why I call disability a poverty trap. And again, it wouldn’t be this way if not for corporate rule. The pharmaceutical lobby is the biggest lobby in the US.  If we had universal healthcare I wouldn’t have a cap on my labor power to keep healthcare. 

The Real Question

Corporations are farming you for labor (employment) and money (consumerism). The real question is “How do we want to be farmed?” Because the truth is corporations are answering that question and ruling the farm and they are not considering the wellbeing of the animals, they are only doing what will extract profit. The reality is the American dream no longer exists. The dream of a house with a white picket fence, car, two kids, and a college degree off one income is a fallacy. That used to make us great. But because of rulings like Buckley v. Valeo we no longer have that standard of living. It’s George Orwell’s “Animal Farm,” where the pigs are changing the rules and can control the farm, but are you just going to give power to them (which [eg oil] corporations would be the pigs in this senario), or do you wanna be self governed?

If you want to take back control there are some ways you can help make a more Democratic government and economy. You should support a graduated tax code. It used to be the poorest Americans paid 10% or less while the wealthiest paid 90% before Regan, now with the Bush and Trump tax cuts the average American pays a higher tax rate than billionaires. If you want things to get better you should be supporting only candidates that support universal healthcare. You can join, start, support, or help build a union. And Support bills that get money out of politics and continually make the internet more free and open.

In conclusion

Labor and subsequently the people have lost power because money is speech. Not only does the American dream not exist, the average American can’t afford to live because Capitalism isn’t being regulated like it should. There's a merger between the political and economic elites while the republicans are slowly fighting and winning for their Christio-fascist agenda.

Lyrics:

American Inequality Taught by Eric Leo 108

America’s an oligarchy One labor exploitation party While they rest and pop Bacardi  We work full-time and still are starving The American dream Is just a marketing scheme For the oligarchy So we don’t question their greed And that money is speech You can buy elections for a fee Just lobby the seat And advertise to the sheep  We have socialism for the rich Capitalism for the poor If you don’t acknowledge this Then you’re ignorant for sure

That’s a Martin Luther King quote  You really need to read more Use your mind, dissent, scold  Learn to debunk the lies told It was once the American dream To be able to afford the house and a property deed Healthcare and a scientific degree While today is hard to afford an apartment for three On minimum wage, you can’t make ends meet That used to make us great, but now the population’s asleep It’s policy that stratified the nation's books Gave tax breaks to the wealthiest when 90% is what they took Now we have a nation of debtors that can’t make it, but work  You can thank the decisions of Trump, Reagan, and Bush As the pigs slowly change the rules the horse screams work harder Just another fascist tactic of the people in charge here Only those who think can understand what they are You should be alarmed because It’s “Animal Farm” and

America’s an oligarchy One labor exploitation party While they rest and pop Bacardi  We work full-time and still are starving The American dream Is just a marketing scheme For the oligarchy So we don’t question their greed And that money is speech You can buy elections for a fee Just lobby the seat And advertise to the sheep  We have socialism for the rich Capitalism for the poor If you don’t acknowledge this Then you’re ignorant for sure

The Supreme Court let corporations overreach Into the coffers of democracy When Citizens United gave unlimited head  To how they equated money to speech I get paid $12 an hour and have a college degree It’s really interesting Americas like you ignorantly Not question the society that seemingly free And Is silent to the oppression economically  The government exploits my labor power for healthcare The systems of poverty trap for the disabled on welfare I worked for a year to make ten grand So I could start my music business and make two albums You can make enough money to not be considered disabled  And still not have enough money to afford your medication I expect at the very least you support this with a click And make sure everyone knows Eric Leo taught you this

America’s an oligarchy One labor exploitation party While they rest and pop Bacardi  We work full-time and still are starving The American dream Is just a marketing scheme For the oligarchy So we don’t question their greed And that money is speech You can buy elections for a fee Just lobby the seat And advertise to the sheep  We have socialism for the rich Capitalism for the poor If you don’t acknowledge this Then you’re ignorant for sure

America’s an oligarchy One labor exploitation party While they rest and pop Bacardi  We work full-time and still are starving The American dream Is just a marketing scheme For the oligarchy So we don’t question their greed And that money is speech You can buy elections for a fee Just lobby the seat And advertise to the sheep  We have socialism for the rich Capitalism for the poor If you don’t acknowledge this Then you’re ignorant for sure

[regulatorsrus]

@saffronique Just wanted to poke you regarding the fines for New Cooperative - that $6k was definitely an air fine. Please *do* reach out to your legislators and demand action, but be aware that the DNR has not yet proposed a fine for this event.

The 5% opacity standard is almost definitely NSPS DDD (40 CFR Part 60, Subpart DDD) which regulates handling, storage, and processing of whole grains. (What can I say, my professionally relevant area is Air.) If there's anything vague/unclear/sketchy, send it my way and I'll be happy to interpret from Regulator to Common.

Hey guys, I know there are a lot of really severe tragedies in the world right now and I in no way desire to push those aside, nor do I really want to load another thing onto people's plates, but anyone here in the US needs to be aware that on March 11, 2024, an agricultural company known as NEW Cooperative spilled 265,000 gallons (1500 tons) of liquid nitrogen fertilizer into the East Nishnabotna River. This is the ecological equivalent of dropping a nuclear weapon into the river. Over a 60 mile stretch downstream of the spill its been a near total ecological wipeout for the river. So far, an estimate of 850,000 fish have been killed from this spill, and that's to say nothing for the insects, amphibians, reptiles and birds that relied on or lived in this river. It is literally filled with animal corpses. This river flows into the Missouri River and the impacts will likely continue to spread far past this 60 mile stretch. And this disaster has barely made local tv in Iowa, let alone national tv, despite the fact that 60 miles of river ecosystem were just wiped out in a way that may be impossible to recover from. And what's the punishment for this heinous act of destruction through negligence, you might ask? As it stands, its looking like a 6k fine from the DNR to the company. Not 600k. Not 60k. 6000 dollars. The maximum fine that the DNR can charge in Iowa is 10k unless they decide to take it further in court. That's why these spills are so frequent in Iowa: it's literally cheaper to eat the fines than it is to bother properly storing fertilizer. I don't know exactly what the proper course of action is here, or who needs to be contacted to enact change--I'm hoping someone more knowledgeable than me will chime in with that information--but at the very least, every one of us should know. Every one of us should make sure we don't forget this. And every one of us should blacklist NEW Cooperative fertilizer unilaterally.

Sources:

[akeliciousmedia]

Anambra State Government Mourns Loss Of Lives In A Tragic Stampede In Okija

The Anambra State Government has expressed deep grief on the tragic loss of lives in the stampede that occurred during a rice-sharing event in Okija town in Ihiala Local Government Area of the state on Saturday. In his expression of sympathy, Anambra State Governor, Professor Chukwuma Charles Soludo, CFR, extends his deepest condolences to the families of the deceased, especially the women, the…

[chemanalystdata]

Levofloxacin Hemihydrate Prices Trend | Pricing | News | Database | Chart

North America

In Q3 2024, the North American market for Levofloxacin Hemihydrate experienced a notable rise in pricing, driven by a combination of influential factors. Heightened demand, fueled by improved consumer confidence and early stockpiling ahead of the Christmas season, served as the primary driver of the price surge.

Supply chain disruptions further exacerbated the situation, with challenges such as the looming threat of port strikes and the ongoing Red Sea crisis constraining supply levels. Additionally, blank sailings and adverse weather conditions contributed to delays and capacity issues, compounding the impact on availability. Within the USA, price fluctuations were particularly pronounced, showing the most significant changes compared to other regions. A 3% price difference between the first and second halves of the quarter highlighted a steady upward trend. However, the quarter-ending price of USD 35,190 per metric ton reflected an -11% decline from the previous quarter.

Overall, the pricing environment in North America exhibited a positive and bullish sentiment, underscored by a consistent upward trajectory throughout the quarter.

Get Real time Prices for Levofloxacin Hemihydrate: https://www.chemanalyst.com/Pricing-data/levofloxacin-hemihydrate-1401

Asia Pacific

Q3 2024 in the APAC region was marked by a significant upward trend in Levofloxacin Hemihydrate prices. This increase was driven by strong global demand, especially from major markets in North America and Europe, where foreign importers took precautionary actions to secure larger orders amid fears of potential shortages.

Logistical challenges, including disruptions in global shipping routes—particularly in the Red Sea—led to higher freight costs, discouraging foreign buyers from placing new orders and contributing to the overall price hike. In China, where price changes were most pronounced, market trends fluctuated due to factors such as extreme weather events, oversupply, and weak domestic demand. Despite these challenges, the overall pricing trend remained positive, with a 4% increase from the first to the second half of the quarter. The quarter-ending price for Levofloxacin Hemihydrate (USP, FDA) FOB Shanghai in China reached USD 33,500 per metric ton, reflecting an optimistic pricing environment driven by ongoing global demand.

Europe

In Q3 2024, Levofloxacin Hemihydrate pricing in Europe followed a notable upward trajectory, supported by several critical factors. Sustained high demand for pharmaceuticals, bolstered by improved consumer purchasing power as inflation eased across the region, played a significant role in driving prices higher.

Logistical challenges, such as the Red Sea crisis disrupting global shipping routes, heightened concerns about supply chain interruptions. This prompted market participants to adopt proactive inventory management strategies to mitigate risks. Escalating shipping costs and port congestion further constrained the supply chain, adding upward pressure on prices. Germany experienced the most substantial price fluctuations, mirroring broader regional trends. Seasonality also played a role, with a 4% price increase between the first and second halves of the quarter. Despite a -12% decline from the previous quarter, the quarter-ending price in Germany stood at USD 34,770 per metric ton for Levofloxacin Hemihydrate (USP, FDA) CFR Hamburg, signaling a positive pricing environment amid strong demand and persistent supply challenges.

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[swiftplasticpallets-blog]

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By choosing High quality Drum Spill Containment Pallets, you’re investing in a solution that saves money in the long run. These pallets help prevent spills that could lead to costly cleanups and equipment damage. This way, you reduce the probability of fines or legal problems.

In conclusion, All in all, Swift Technoplast introduces its new drum spill containment pallets the DSCP-SL2 for 200-liter capacities and the DSCP-SL4, which comes with a sump capacity of up to 525 liters, ensure complete protection while ensuring compliance throughout your business premises. Whether you need a compact solution or a high-capacity option, these pallets improve workplace safety and efficiency.

Don’t leave spill management to chance—upgrade to our all-new drum spill containment pallets today and safeguard your workspace, employees, and the environment.

[talentdevelopments]

Benefits of Choosing LMS Company in UAE

Empower Your Workforce with Talent Development’s AI-Integrated Pharma LMS Comprehensive Training Solution Powered by AI

Talent Development’s AI-enabled Learning Management System (LMS) is designed for highly regulated industries like Corporate, University, College, Schools, Life sciences, Food & Beverages, Cosmetics, Gene Therapy, and Medical Devices. It focuses on compliance, accessibility, and global scalability, delivering a seamless user experience.

Key Benefits of Learning Management System

Regulatory Compliance Effortlessly meet FDA 21 CFR Part 11 and other key regulatory standards.

Global Accessibility Access training materials anywhere, anytime, fostering flexibility and continuous learning.

AI Integration Utilize innovative AI features such as automatic question generation.

Scalability Ensure consistent training across global locations, promoting uniformity and quality control.

Why Choose Talent Development LMS?

Talent Development’s AI-powered LMS provides comprehensive training solutions for regulated industries. LMS in UAE With features like centralized course management, customized induction programs, and seamless integration with third-party systems, it enhances compliance, productivity, and accessibility on a global scale.

Features of Talent Development LMS

Course Creation and Management Easily manage, centralize, and deliver a variety of training resources across formats. Integrate seamlessly with Document Management Systems for Standard Operating Procedures (SOP) access.

Induction Training and Employee Management Customize orientation programs and automate job-specific training assignments for new employees. Track and update job roles efficiently.

On-the-Job Training Plan and assess on-the-job training, ensuring employees meet competency standards for specific job functions.

User Enrollment or Self-Registration Create and manage users, allocate courses by department, and enable self-registration for role-specific training.

Training Sessions Scheduling Plan, reschedule, and track various training sessions. Ensure high-quality training with competent trainers.

Role-Based Training Assign courses automatically based on user roles. Ensure continuous engagement through auto-reminders.

Assignments, Tests, and Exams Create diverse assessments, automatically assign courses based on job roles, and generate complex assignments.

AI-Powered Questionnaire Creation Effortlessly generate effective training questionnaires using AI, drawing from entire documents or specific sections.

Designed for Regulated Industries Ensure compliance and operational excellence in regulated sectors, enhancing workforce efficiency.

Test Scores, Grades, and Results Track overall learner performance with detailed test scores and analytics.

Biometric System Integration Monitor attendance accurately with biometric fingerprint technology.

MCQ-Based Training Develop multiple-choice questions to efficiently train staff on the latest SOPs.

Email Alerts, Notifications, and Escalation Automate reminders, alerts, and notifications for upcoming training, overdue courses, and other critical events.

Enhanced Compliance Training Ensure effective compliance training to meet industry standards and regulations.

Save Time and Increase Efficiency Boost training efficiency, saving time while delivering up-to-date knowledge to employees.

Business Process Excellence Improve business processes and maintain accuracy by building a knowledgeable workforce.

Your Benefits of Choosing Talent Development LMS:

Client-Oriented We prioritize your unique needs and challenges, tailoring solutions that align with your business goals.

Independent we offer unbiased recommendations, ensuring the best fit for your organization’s requirements.

Competent Our expert team brings industry knowledge and regulatory insights to every solution we provide.

Results-Driven Our focus is on delivering measurable outcomes that boost your business performance and compliance.

Problem-Solving We tackle complex challenges with innovative and practical solutions that ensure smooth implementation.

Transparent Our processes are clear and transparent, keeping you informed every step of the way.

What Happens Next?

Schedule a Call Arrange a consultation with our experts at your convenience.

Discovery and Consultation Session Engage in a tailored discovery session to identify your LMS needs and explore how Talent Development can support your objectives.

Schedule a Free Demo Experience LMS Company in UAE. Schedule a free demo to see how our AI-powered Pharma LMS can transform your training and compliance processes.

Maximize the potential of your workforce and stay ahead in regulated industries with Talent Development’s AI-driven Learning Management System.

[krusewins]

Flexible Solutions: Office Furniture on Rent

In today’s dynamic work environment, many businesses are turning to renting office furniture as a practical solution to meet their evolving needs. Whether you're a startup looking to create an efficient workspace or an established company needing temporary furniture for an event, renting office furniture offers flexibility and convenience.

Benefits of Renting Office Furniture

1. Cost-Effective

Renting furniture can significantly reduce upfront costs compared to purchasing. This is especially beneficial for startups and small businesses that may have budget constraints.

2. Flexibility

As your business grows or changes, so do your furniture needs. Renting allows you to easily adapt to these changes without the long-term commitment of purchasing.

3. Access to Quality Products

Many rental companies provide high-quality, stylish furniture options. This means you can create a professional workspace without compromising on aesthetics.

4. Convenience

Rental services often include delivery, setup, and pickup, saving you time and effort. This is especially useful for temporary setups, like conferences or events.

What to Consider When Renting Office Furniture

When renting office furniture, keep the following factors in mind:

Duration of Rental: Determine how long you need the furniture. Some companies offer flexible terms for short- or long-term rentals.

Style and Functionality: Consider the type of work being done in your space and choose furniture that enhances productivity and comfort.

Delivery and Setup Services: Ensure the rental company provides delivery and setup to make the process seamless.

Where to Rent Office Furniture

For a wide range of quality office furniture on rent, look no further than CFR Direct. They offer comprehensive rental solutions tailored to your business needs.

Contact Information

Phone: 973-442-1577

Email: info@cfrdirect.com

Website: http://cfrdirect.com

Conclusion

Renting office furniture is a smart, flexible solution for businesses of all sizes. Explore the options available at CFR Direct and find the perfect furniture to create a functional and stylish workspace.

[rudrasurgicals02]

Key Regulations Followed By Laparoscopic Instruments Manufacturer In India

Laparoscopic instrument manufacturers must adhere to stringent regulations to ensure the safety, effectiveness, and quality of their products. These regulations are enforced by various national and international health authorities to ensure that laparoscopic devices meet medical standards for patient safety. Here are some of the key regulations followed by Laparoscopic Instruments Manufacturer In India:

1. ISO Standards for Quality Management

ISO 13485 Certification: This is the internationally recognized standard for quality management systems specific to medical device manufacturers. It ensures that laparoscopic instruments are designed, developed, and manufactured under stringent quality controls.

ISO 14971 – Risk Management: Manufacturers must comply with this standard to manage the risks associated with the design and production of laparoscopic instruments. This includes risk identification, analysis, and mitigation throughout the product lifecycle.

2. FDA (Food and Drug Administration) Regulations

FDA 21 CFR Part 820 – Quality System Regulation (QSR): Manufacturers selling in the U.S. must comply with the FDA’s QSR, which outlines requirements for designing, manufacturing, packaging, and distributing medical devices.

Premarket Approval (PMA): For certain Class III medical devices, manufacturers must obtain FDA approval through the PMA process, demonstrating the safety and effectiveness of the laparoscopic instruments before they can be marketed.

510(k) Clearance: Many laparoscopic instruments fall under Class II devices, requiring manufacturers to submit a 510(k) premarket notification to the FDA. This process requires proving that the new device is substantially equivalent to an already legally marketed device.

3. CE Marking and European Union Medical Device Regulations (MDR)

CE Mark Certification: For manufacturers selling in Europe, obtaining the CE mark is mandatory.

EU MDR (Medical Device Regulation): The EU MDR requires manufacturers to provide comprehensive documentation, including clinical evidence of the device’s safety and performance. It also emphasizes post-market surveillance and reporting of adverse events.

4. Good Manufacturing Practices (GMP)

Compliance with GMP Guidelines: Manufacturers must follow GMP practices, which ensure that laparoscopic instruments are consistently produced and controlled according to quality standards. This includes maintaining cleanroom environments, proper equipment maintenance, and employee training.

Traceability and Documentation: GMP also requires maintaining detailed records of production batches, testing, and quality checks to ensure traceability and accountability.

Rudra Surgical is known as Laparoscopic Simulator Virtual Endo Trainer Manufacturer in India. If you or anyone you might know is searching for a reliable manufacturer of laparoscopic instruments, then you can connect with Rudra Surgical.

About Rudra Surgical

Rudra Surgical is one of the leading names because it offers a wide range of medical equipment by designing it precisely. To know more details about various medical equipment, you can connect with them without any delay.

[conferencepanel]

What is 21 CFR Part 11 Good Documentation Practices?

Good documentation practices (GDP) are a cornerstone of regulatory compliance under 21 CFR Part 11, ensuring the accuracy, integrity, and reliability of electronic records and electronic signatures. These practices provide a structured approach to creating, managing, and storing documentation in a way that meets regulatory standards set by the FDA.

Key Components of Good Documentation Practices

Record Authenticity and Integrity Documentation must be authentic, accurate, and free from unauthorized alterations. This includes ensuring that electronic records are created and maintained in a secure environment where any changes are tracked through audit trails. The authenticity of records guarantees that they are a true reflection of the actual event or transaction.

Audit Trails As part of good documentation practices, audit trails capture every modification made to electronic records. These records must include the who, what, when, and why of each change, ensuring that documentation remains traceable and verifiable over time.

Electronic Signatures Under 21 CFR Part 11, electronic signatures must be uniquely assigned to authorized personnel and must be linked to their corresponding documents. Good documentation practices ensure that electronic signatures are secure, verified, and cannot be falsified.

Data Storage and Retention The proper storage and retention of records are critical to compliance. Records must be stored in a secure, validated system that prevents loss, tampering, or unauthorized access. Good documentation practices dictate that records are kept for the duration specified by regulatory requirements.

Controlled Access, Good documentation practices include strict access control policies to ensure that only authorized personnel can access or modify records. Implementing role-based access controls and requiring authentication helps to safeguard the integrity of electronic documentation.

In conclusion, 21 CFR Part 11 good documentation practices are essential for ensuring that electronic records and signatures meet FDA compliance standards, safeguarding the reliability and integrity of digital data.

[worldofwardcraft]

The one-man crime wave.

September 9, 2024

Just like a Mafia boss, persistent scofflaw Donald Trump simply can't stop himself from committing crimes. He's already been adjudicated a rapist and sexual abuser as a result of the E. Jean Carroll defamation case. His personally owned company has been found guilty of business fraud. A New York jury found him guilty of 34 felony charges to illegally influence the 2016 election through a hush money payment to a porn actor. And he's under indictment in Georgia for election tampering. He's also been fined millions for operating a scam charity foundation and fake "Trump University."

Plus, he's being prosecuted in Florida for illegal retention of highly secret government documents. And while this case was erroneously dismissed by District Judge and Trump fangirl Aileen Cannon, it will no doubt be reinstated upon appeal to the 11th Circuit Court.

In addition, Special Counsel Jack Smith recently filed a superseding indictment that again accuses Trump of defying the peaceful transfer of power after the 2020 presidential election. This became necessary after the corrupt political hacks on the Supreme Court invented a special rule making Trump immune from prosecution for certain conduct alleged in last year's original indictment.

The new 36-page filing maintains the original four charges — including conspiracy to defraud the United States — but leaves out evidence the Court ruled inadmissible. Now, as former US Attorney Joyce Vance points out, trial judge Chutkan "will have to decide what, if anything more, she will remove based on the arguments Trump’s lawyers will make."

But despite his ongoing criminal prosecutions, Trump refuses to cease lawbreaking. Only weeks ago, he attended ceremonies at Arlington National Cemetery consisting of a wreath laying at the Tomb of the Unknowns and a memorial at a grave in section 60, which is reserved for recent US casualties. Naturally, he turned it all into a campaign event and posted a video of it on TikTok. Which is in direct violation of federal regulation 32 CFR 533.22 prohibiting political activity at Arlington. Reported The Washington Post:

It’s exactly what military officials tried to prevent. The use of the footage marked a flagrant violation of the law against partisan actions at military cemeteries, defense officials said.

Any other convicted felon who, while out on release awaiting sentencing, continues to commit crimes, would have his bail revoked forthwith and be immediately remanded to custody. But not Trump. As political blogger Jeff Tiedrich remarks, courts seem to think he's a "very special boy." He's also a very determined criminal.

[sa7abnews]

Russia's exit from top European sports body approved

New Post has been published on https://sa7ab.info/2024/08/16/russias-exit-from-top-european-sports-body-approved/

Russia's exit from top European sports body approved

Russia will become part of the Asian Chess Federation if accepted, the international body has ruled

Russia is free to leave the European Chess Union (ECU) and join its Asian counterpart, should the move be approved by the latter organization, it was announced by international governing body FIDE on Wednesday. The decision followed a request by the Chess Federation of Russia (CFR). The Asian Chess Federation (ACF) is now expected to decide on Russia’s request at its General Assembly, which will be held in Abu Dhabi on February 28. A Russian delegation at the gathering will be led by the head of the CFR, Andrey Filatov, national media reported. If the ACF does accept Russia, FIDE explained that the country would automatically withdraw from the ECU, adding that a chess federation cannot be part of two continental bodies at the same time. FIDE also decided that Russia will be redesignated as part of the Asian region starting from May 1, in the event that it is approved for membership by the ACF.

Read more

Location revealed for Russian star’s world chess title bid

FIDE determined that Russian chess players who wish to join other federations in light of the potential changes can do so immediately upon request and without incurring any fees. Players can later return to the CFR under the same conditions, it added. Back in March 2022, FIDE allowed chess players from Russia and Belarus to continue to participate at international tournaments, but only under neutral status. The ACF currently features 54 national federations, including prominent chess powers such as China, India, and Uzbekistan. FIDE’s decision comes ahead of a world title contest between Russian grandmaster Ian Nepomniachtchi and Chinese rival Ding Liren. Nepomniachtchi ranks third in the world, while his opponent lies second. They will face off in a series of games in Astana from April 7 to May 1. A new world champion will be crowned following the withdrawal of reigning five-time champion Magnus Carlsen of Norway, who announced last year that he would not be defending his title in 2023.