IT’S A NO BRAINER! Action needed to stop children being exposed to chemicals that harm their brain development!

A report published today by CHEM Trust highlights how chemicals in food and consumer products used in homes, schools and offices could harm brain development in children.

The impacts – which may include ADHD and lower IQ – are avoidable and can prevent children reaching their full potential says CHEM Trust, in No Brainer: The impact of chemicals on children’s brain development: a cause for concern and a need for action.
Researchers have shown that many thousands of people have been exposed to now largely-banned chemicals such as lead and PCBs at high enough levels to have harmed their brain function. Now there is growing concern about the impacts of exposures to many of the ‘new’ chemicals in our 21^st century lifestyles.
Chemicals of concern include brominated flame retardants (BFRs), a group of chemicals added to furniture, electronics and building materials, per- and poly- fluorocarbons (PFCs), used for non-stick coatings or breathable coatings in everyday products including packaging and clothes. Some chemicals in these groups are being phased out, but similar chemicals remain in everyday use.
The study also points out the unpleasant reality that children are constantly exposed to a cocktail of chemicals, which can act together, something which is still largely ignored by chemical safety laws.
CHEM Trust proposes a range of policies that could help address this challenge, for example faster regulatory action on groups of similar chemicals, and development of new methods for identifying chemicals of concern. They also include advice for consumers on how to reduce their exposure.
Dr Michael Warhurst, Executive Director of CHEM Trust, said:

“The brain development of future generations is at stake. We need EU regulators to phase out groups of chemicals of concern, rather than slowly restricting one chemical at a time. We cannot continue to gamble with our children’s health.”

The report has been peer reviewed by two eminent scientists in the field, Professor Philippe Grandjean and Professor Barbara Demeneix.
Prof Barbara Demeneix (Laboratory of Evolution of Endocrine Regulations, CNRS, Paris) said:

“Chemical exposure is now at unprecedented levels, is multiple, ubiquitous, and present from conception onwards”

Prof. Philippe Grandjean (Department of Environmental Medicine, University of Southern Denmark), added:

“The current generation has the responsibility to safeguard the brains of the future”
“I would insist that the Precautionary Principle must be applied in order to protect the next generation’s brains.”

Read More: http://snip.ly/maoou#http://www.chemtrust.org/brain/

Putting an effective complaint and recall management system in place

Complaints very strongly show a company how its products or services are perceived where it matters the most -in the customer’s mind. Complaint handling is one of the key indicators of how seriously a business takes its customers’ point of view. Complaints are to be expected from about any product; but their importance is all the more felt in an area like medical devices, because these products can affect the very life of their users.
In the context of medical devices; complaints are any communication made in writing, electronically or in verbal form about any of these aspects of a medical device after its release for the purpose of distribution: identity, quality, durability, reliability, safety, effectiveness, or performance
FDA and ISO standards

The FDA has a very clear and well-defined set of regulatory guidelines on complaint handling in the field of medical devices. These are set out in FDA 21 CFR 820.198. The FDA requires medical device companies to also comply with ISO 13485:2016 Section 8.2.2., which suggests what document procedures to put in place to ensure timely handling of complaints in a compliant manner. Just how seriously the FDA takes complaint handling can be gauged from the fact that deficiency in complaint handling is one of the top reasons quoted for issuance of 483’s by the FDA.
Although complying with these regulations is a part of regulatory requirements; these regulations only mention what needs to be done in order to maintain a complaint and recall management system; how to do it is left to the individual medical device company. These regulations specify the exact elements of a complaint handling system, such as maintaining complaint files, proceeding about the complaints in a timely manner, documenting verbal complaints, and so on. However, it is up to the medical device manufacturer to implement the complaint handling and recall system in such a manner that it is perfectly streamlined and organized to the point where the complaint is handled exactly in the manner prescribed.
Full learning on how to implement an effective and compliant complaint and recall management system
The ways by which medical device companies can do this to optimize their complaint handling mechanism will be the teaching from a two-day seminar that GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, is organizing. At this seminar, John Kasoff, Director of Regulatory Affairs, Life-Tech, Inc. and Principal Consultant at Lean to Quality, LLC, who brings more than three decades of experience in Quality and Regulatory management, during which he has implemented and overseen quality system operations and assured compliance, at all companies of all sizes, from start-up to more than $100 million in revenue; will be the Director.

Please visit Putting an effective complaint and recall management system in place to enroll for this seminar and gain thorough understanding of how to put an effective complaint and recall management system in place. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.
An activity that cuts across many cross functions
Jeff will emphasize the point that complaint handling is a highly coordinated, cross functional area for a medical device company’s Quality System. Almost all niche areas of the medical device company, such as customer service, sales and marketing, Regulatory Affairs, QA, R and D, and Quality Engineering, are involved in complaint handling. This makes the need for orchestrated coordination and synchrony between these departments a must, for if the complaint handling mechanism is not well lubricated; it is bound to make the complaint handling act a failure, inviting all the undesirable penal actions from the regulatory and enforcement agencies.
John will highlight the role and importance of each of these functions in complaint handling. In these, activities relating to defining, documenting, and implementing a complaint-handling system, the requirements for complaint review, investigation, and corrective action, as well as ISO-specific implications, will be discussed in detail.
Distinguishing between complaints and “non-complaints”
He will also explain what constitutes a complaint, and will suggest recommended practice on the ways of handling “non-complaint” feedback. He will also show how to apply risk management to a complaint handling system, and explain a specific risk management system to drive home this point.
A substantial part of this seminar will be spent on making a streamlined review of the regulations, at which the critical process requirements for compliance with the regulations will be examined in detail. Jeff will offer straightforward and compliant recommendations for the methods of documentation relating to complaint records, root cause investigations, and corrective actions, and show how to apply risk management principles to complaint investigation.
To join us for more information, get in touch

The use of Applied Statistics for FDA Process Validation

The use of Applied Statistics for FDA Process Validation is considered a matter of very high importance in the pharmaceutical industry. The FDA’s guidance for the industry, which it called “Process Validation: General Principles and Practices”, was set up in 2011. This guideline sets the framework for Process Validation in the pharmaceutical industry. The FDA prescribes a three-stage process that any organization in the pharmaceutical industry has to set up:

1. Process Design
2. Process Qualification

• Continued Process Verification.

The Process Design stage, which is called Stage 1, is when the organization defines the commercial manufacturing process. The knowledge that the organization has gained through development and scale-up activities serves as the basis for the development of this definition.
The Process Qualification, or Stage 2, involves evaluating the process design for the purpose of determining if the process defined in Stage I has the capability for reproducible commercial manufacturing.
The next stage of the FDA process validation stage is to determine if the Process Design stage and the Process Qualification stage give the ongoing assurance that the process remains in a state of control during routine production. This is what Stage 3, the Continued Process Verification, does.
Thorough understanding of how to implement Applied Statistics for FDA Process Validation

The ways of using Applied Statistics for FDA Process Validation will be the topic of a two-day seminar that GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, will be organizing. At this seminar, Richard Burdick, Emeritus Professor of Statistics, Arizona State University (ASU) and former Quality Engineering Director for Amgen, Inc., will be the Director.
Please visit http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901132SEMINAR?wordpress-SEO to register for this meaningful and highly valuable seminar on applied statistics for process validation. This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.
A methodical approach to implementing statistical methodologies

The focus of this two-day course on Applied Statistics for FDA Process Validation is the various ways by which a systematic approach to implementing statistical methodologies into a process validation program consistent with the FDA guidance can be established.
Dr. Burdick will begin with a primer on statistics, where he will explain how the methods of Applied Statistics for FDA Process Validation seminar can be applied in each remaining chapter.
The two fundamental requirements for Process Validation, namely the application of statistics for setting specifications and assessing measurement systems (assays), will be taken up next.
The next aspect of applied statistics Dr. Burdick will move on to is how to apply statistics through the three stages of process validation as defined by requirements in the process validation regulatory guidance documents.
Since the methods taught through all these three stages are recommended by regulatory guidance documents; this seminar on Applied Statistics for FDA Process Validation will provide references to the specific citations in the guidance documents.
The aim of this learning on Applied Statistics for FDA Process Validation is to lead participants into ways of establishing a systematic approach to implementing statistical methodologies into a process development and validation program that is consistent with the FDA guidance.
Complete learning on Applied Statistics for FDA Process Validation

Over the two days of this seminar, the participants will learn how to:

• Apply statistics for setting specifications
• Assess measurement systems (assays)
• Use Design of Experiments (DOE)
• Develop a control plan as part of a risk management strategy, and
• Ensure process control/capability.

All concepts at this Applied Statistics for FDA Process Validation seminar are taught within the three-stage product cycle framework defined by requirements in the process validation regulatory guidance documents.
Although aimed at the pharmaceutical industry, this seminar on Applied Statistics for FDA Process Validation provides a useful framework for other related industries, as well.
In this important learning on Applied Statistics for FDA Process Validation; Dr. Burdick will cover the following areas:

• Apply statistics to set specifications and validate measurement systems (assays)
• Develop appropriate sample plans based on confidence and power
• Implement suitable statistical methods into a process validation program for each of the three stages
• Stage 1, Process Design: utilize risk management tools to identify and prioritize potential critical process parameters; and define critical process parameters and operating spaces for the commercial manufacturing process using design of experiments (DOE)
• Stage 2, Process Qualification: assess scale effects while incorporating large (pilot and/or commercial) scale data; develop process performance qualification (PPQ) acceptance criteria by characterizing intra and inter-batch variability using process design data and batch homogeneity studies; and develop an appropriate sampling plan for PPQ
• Stage 3, Continued Process Verification: develop a control plan as part of a risk management strategy; collect and analyze product and process data; and ensure your process is in (statistical) control and capable.

keep enhancing FDA Process Validation

The science of Sad: understanding the causes of ‘winter depression’

For many of us in the UK, the annual ritual of putting the clocks back for daylight saving time can be accompanied by a distinct feeling of winter blues as autumn well and truly beds in. This might be felt as a lack of energy, reduced enjoyment in activities and a need for more sleep than normal. But for around 6% of the UK population and between 2-8% of people in other higher latitude countries such as Canada, Denmark and Sweden, these symptoms are so severe that these people are unable to work or function normally. They suffer from a particular form of major depression, triggered by changes in the seasons, called seasonal affective disorder or Sad.
In addition to depressive episodes, Sad is characterised by various symptoms including chronic oversleeping and extreme carbohydrate cravings that lead to weight gain. As this is the opposite to major depressive disorder where patients suffer from disrupted sleep and loss of appetite, Sad has sometimes been mistakenly thought of as a “lighter” version of depression, but in reality it is simply a different version of the same illness. “People who truly have Sad are just as ill as people with major depressive disorder,” says Brenda McMahon, a psychiatry researcher at the University of Copenhagen. “They will have non-seasonal depressive episodes, but the seasonal trigger is the most common. However it’s important to remember that this condition is a spectrum and there are a lot more people who have what we call sub-syndromal Sad.”

Around 10-15% of the population has sub-syndromal Sad. These individuals struggle through autumn and winter and suffer from many of the same symptoms but they do not have clinical depression. And in the northern hemisphere, as many as one in three of us may suffer from “winter blues” where we feel flat or disinterested in things and regularly fatigued.

One theory for why this condition exists is related to evolution. Around 80% of Sad sufferers are women, particularly those in early adulthood. In older women, the prevalence of Sad goes down and some researchers believe that this pattern is linked to the behavioural cycles of our ancient ancestors. “Because it affects such a large proportion of the population in a mild to moderate form, a lot of people in the field do feel that Sad is a remnant from our past, relating to energy conservation,” says Robert Levitan, a professor at the University of Toronto. “Ten thousand years ago, during the ice age, this biological tendency to slow down during the wintertime was useful, especially for women of reproductive age because pregnancy is very energy-intensive. But now we have a 24-hour society, we’re expected to be active all the time and it’s a nuisance. However, as to why a small proportion of people experience it so severely that it’s completely disabling, we don’t know.”

Nobel prizes 2017: everything you need to know about circadian rhythms

There are a variety of biological systems thought to be involved, including some of the major neurotransmitter systems in the brain that are associated with motivation, energy and the organisation of our 24-hour circadian rhythms. “We know that dopamine and norepinephrine play critical roles in terms of how we wake up in the morning and how we energise the brain,” Levitan says. One particular hormone, melatonin, which controls our sleep and wake cycles, is thought to be “phase delayed” in people with severe Sad, meaning it is secreted at the wrong times of the day.

Another system of particular interest relates to serotonin, a neurotransmitter that regulates anxiety, happiness and mood. Increasing evidence from various imaging and rodent studies suggests that the serotonin system may be directly modulated by light. Natural sunlight comes in a variety of wavelengths, and it is particularly rich in light at the blue end of the spectrum. When cells in the retina, at the back of our eye, are hit by this blue light, they transmit a signal to a little hub in the brain called the suprachiasmatic nucleus that integrates different sensory inputs, controls our circadian rhythms, and is connected to another hub called the raphe nuclei in the brain stem, which is the origin of all serotonin neurons throughout the brain. When there is less light in the wintertime, this network is not activated enough. In especially susceptible individuals, levels of serotonin in the brain are reduced to such an extent that it increases the likelihood of a depressive episode.

Read More: http://snip.ly/25gi4#https://www.theguardian.com/lifeandstyle/2017/oct/30/sad-winter-depression-seasonal-affective-disorder
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Second Death From Flesh-Eating-Bacteria Infection After Hurricane Harvey Is Reported

A 31-year-old man who helped to repair homes in Galveston, Texas after flooding caused by Hurricane Harvey was recently diagnosed with flesh-eating bacteria and died on October 16th after being admitted to a hospital on October 10th, according to a statement released by health officials in Galveston on Monday.
He is the second person to die from flesh-eating bacteria since Hurricane Harvey struck the Gulf Coast. Two weeks ago, a 77 year old woman died after a fall inside her flooded home in which she cut her arm and subsequently contracted the flesh-eating bacteria.
When the man initially presented to the hospital on October 10th, officials described an infected wound affecting the upper portion of his left arm.

The aggressive and deadly soft tissue infection is formally referred to as necrotizing fasciitis . It’s a rare infection under normal circumstances, but if promptly recognized, diagnosed and treated with the appropriate antibiotics and surgery to remove dead or dying tissue, the majority of patients recover without any serious consequences.

Necrotizing fasciitis, or “nec fasc”, is most commonly caused by Group A Strep , but a mixed infection with anaerobic bacteria including Clostridium may also develop, leading to what is commonly known as gas gangrene. Necrotizing fasciitis causes pain out of proportion in the affected area, relative to the degree of injury.

A cut, scrape, puncture or any break in the skin may serve as a portal of entry for the dangerous bacteria, which then leads to destruction of blood vessels, fat, nerves and a white fibrous covering of the muscle known as the fascia. The infection then proceeds to enter the muscle, compromising blood flow and leading to death of the tissue.
Its important to realize that bacteria don’t actually digest the tissue, but instead produce a deadly toxin that is responsible for the extensive tissue damage.
As the bacteria enter the bloodstream, fever, chills and vomiting may rapidly develop, leading to a dangerous condition known as sepsis which is characterized by low blood pressure, rapid and difficult breathing and confusion.

Early warning signs include severe pain and tenderness in the infected area, spreading redness and warmth and blue to purple skin discoloration, with darkened tissue in the later stages. The presence of gas or air in the soft tissue known as “crepitus” produces a crackling sound or crunching sensation if the area of skin is palpated. An abscess containing pus may also form as the infection becomes more organized.

Necrotizing fasciitis is a surgical emergency. Aggressive fluid resuscitation along with broad spectrum antibiotics must be started promptly with emergent preparation for surgery to remove or debride the affected area in order to contain the infection.
Persons with diabetes, chronic kidney disease and cancer who are receiving chemotherapy are most at risk for complications, due to poor blood supply to skin, muscle and soft tissue from having such chronic conditions.
Flood waters harboring bacteria (from sewage), along with dirty surfaces or debris contacting the victim’s initial cut or injury, likely led to the onset of this aggressive and deadly infection. As a general rule, it’s best to keep all cuts or blisters covered with a dry gauze and waterproof type dressing if there is any potential to come in contact with floodwater or dirty surfaces or debris.
The CDC describes about 700-1,110 cases annually in the U.S., the result of an active surveillance and reporting network that is set up to monitor such aggressive infections.
Cases of typhoid and cholera, invasive and aggressive diarrheal illnesses typically associated with floods in developing countries, never materialized after the hurricane, according to data from the CDC. In addition, cases of tetanus, which can develop from heavily contaminated wounds after soil exposure, have generally not been a concern with such flooding in the U.S., as supported by data from the CDC.
“Necrotizing fasciitis is caused by strep group A (flesh-eating bacteria) or anaerobic bacteria which thrive in areas without oxygen,” said Debra Spicehandler, MD, Co-Chief of Infectious Diseases, Northern Westchester Hospital.  ”Antibiotics are important but swift surgical debridement is necessary. The cases caused by strep release a toxin which can also cause systemic effects and organ failure leading to mortality.”
Read More: http://snip.ly/rjcse#https://www.forbes.com/forbes/welcome/?toURL=https://www.forbes.com/sites/robertglatter/2017/10/25/second-victim-of-flesh-eating-bacteria-after-hurricane-harvey-dies/&refURL=&referrer=

Heart surgery survival chances ‘better in the afternoon’

Open heart surgery appears to be safer in the afternoon because of the body’s internal clock, scientists have said.

The body clock – or circadian rhythm – is the reason we want to sleep at night, but it also drives huge changes in the way our bodies work.
The research, published in the Lancet, suggests the heart is stronger and better able to withstand surgery in the afternoon than the morning.
And it says the difference is not down to surgeons being tired in the morning.
Doctors need to stop the heart to perform operations including heart valve replacements. This puts the organ under stress as the flow of oxygen to the heart tissue is reduced.
The doctors and researchers looked for complications including heart attacks, heart failure or death after surgery. They found:

• 54 out of 298 morning patients had adverse events
• 28 out of 298 afternoon patients had adverse events
• Afternoon patients had around half the risk of complications
• One major event would be avoided for every 11 patients operated on in the afternoon

One of those involved in the research, Prof Bart Staels, from the Institut Pasteur de Lille, told the BBC News website: “We don’t want to frighten people from having surgery – it’s life saving.”
He also said it would be impossible for hospitals to conduct surgery only after lunch.
But Prof Staels added: “If we can identify patients at highest risk, they will definitely benefit from being pushed into the afternoon and that would be reasonable.”
Obesity and type 2 diabetes have been shown to increase the risk of complications after surgery.
Heart health is already known to fluctuate over the course of a day.
The risk of a heart attack or stroke is highest first thing in the morning, while the heart and lungs work at their peak in the afternoon.

 

Dr John O’Neill, from the UK Medical Research Council’s Laboratory of Molecular Biology, said: “Scientifically it is not hugely surprising, because just like every other cell in the body, heart cells have circadian rhythms that orchestrate their activity.
“Our cardiovascular system has the greatest output around mid/late-afternoon, which explains why professional athletes usually record their best performances around this time.”

• BBC Body Clock: What makes you tick?
• Body clock scientists win Nobel Prize
• Weekend camping resets body clock

Other possible explanations for the findings included surgeons being tired in the morning or their own body clock affecting their surgical skill, particularly if they are not “morning people”.
Read More: http://snip.ly/lr9h9#http://www.bbc.com/news/health-41763958

Forbes Talks Taxes, Healthcare in Address to Students

As Republicans struggle to score a legislative win on taxes, Steve Forbes dismissed fears that the American economy is doomed to slow economic growth or secular stagnation as “preposterous.”
Forbes, the chairman and editor-in-chief of Forbes Media and former Republican presidential candidate, blamed the current economic rut on correctable policy errors in a lecture sponsored by the Cornell Republicans on Wednesday.
The real source of wealth in society derives not from physical things, Forbes said, but from the human mind, as the modern economy cannot prosper without “human ingenuity.” Free markets will always turn scarcity into abundance, he said, using automobile innovation as an example.
“One hundred twenty years ago, a car costed over 110,000 dollars,” he said. “It was a toy for the rich. But Henry Ford came along with the moving assembly line and turned this toy for the rich into something every working person can afford.”
Rejecting the argument that automation will deprive Americans of jobs, Forbes said that free markets will allow people to apply ingenuity and advance a society built on knowledge and innovation.
The fear of robots, he said, is misguided, since society has been utilizing robots throughout history. He urged students to think about how the invention of the tractor — which was viewed as a robot when it was first introduced — freed up millions of acres for farmland and hours of labor.
Forbes also said that Republicans are unable to pass a tax cut because they are putting “process before progress,” and relying too heavily on the Congressional Budget Office to predict the future to change various laws and tax codes.
“The blunt truth is, if the Congressional Budget Office knew what would happen, they would be buying lottery tickets or speculating commodities,” he said.
Forbes proposed that Republicans follow the actions of Ronald Reagan and pursue a straight tax cut, which he said would reduce the business tax rate to 15 percent.
Republicans led on cuts to healthcare rather than taxes primarily because the CBO calculated that the government would save $1.1 trillion over the next 10 years following healthcare cuts, which would ultimately allow for additional tax cuts, Forbes said. However, the plan to cut healthcare and then follow up with cuts to larger company’s tax bills is an unfortunate message to the American people, he said.
Forbes also criticized the federal income tax code, calling it a “monstrosity” that not even experts in the Internal Revenue Service truly understand.
“Take this monster,” he said, referring to the federal income tax code. “I would say bury it, but I don’t know if the EPA would let us bury something so toxic.”
The problem with the American healthcare system stems from the lack of real free markets, Forbes said. There is a disconnect between providers and consumers, since the system is controlled by insurance companies, rather than by the patient. Hospitals’ revenues depend on negotiations with insurers and the government, but not with satisfying patients, he said.
“The crummiest motel in America wouldn’t dare put you in a room with another guest with a curtain in between,” he said. “But they do it routinely in hospitals.”
Nationwide “shopping” for health insurance, equal tax treatment and increased transparency between hospitals and patients are all factors key to improving the healthcare system, Forbes said.
Hospitals should also be mandated to publicly post how many patients die from infections they have received after admission to the hospital, he said.
“Ninety thousand patients die from infections after being admitted to hospitals,” he said. “Experts say 80 percent of these deaths could be prevented.”

keep enhancing Healthcare

Precision medicine: From ‘one-size-fits-all’ to personalized healthcare

Imagine a future in which, rather than using symptoms to identify a disease, your genes, metabolism, and gut microbiome inform how your individual health is managed. This is the vision of precision medicine.

Traditional medicine uses symptoms to diagnose diseases, and drugs to treat these symptoms. But precision medicine aims to turn this concept on its head.
By identifying the factors that predispose a person to a particular disease and the molecular mechanisms that cause the condition, treatment and prevention strategies can be tailored to each individual. 
So, how do we get from traditional to precision medicine? Advances in genetics and molecular analysis techniques have been a deciding factor, as has getting patients involved with managing their own health.
However, is precision medicine going to revolutionize how we treat all medical conditions, or will it be the privilege of a select few?

Innovation drives precision medicine

To the National Institutes of Health (NIH), “[P]recision medicine is a revolutionary approach for disease prevention and treatment that takes into account individual differences in lifestyle, environment, and biology.”
Launched by President Barack Obama in 2015, the Precision Medicine Initiative “will pioneer a new model of patient-powered research that promises to accelerate biomedical discoveries and provide clinicians with new tools, knowledge, and therapies to select which treatments will work best for which patients.”
Breakthroughs in molecular biology have been key to getting precision medicine off the ground.
Next-generation DNA sequencing is now routinely used to identify genetic mutations that drive specific cancers, and biomarkers that predict disease risk or how well a person will respond to a particular treatment are increasingly becoming reality in medical practice.
Cancer is the one area wherein precision medicine seems to be making significant headway. New therapies seek to target the specific cellular pathway that is being exploited by a cancer, with the view to making short the life of the tumor.
This approach is already being employed in clinical trials to treat patients with melanoma who have a mutation in the BRAF gene, as Medical News Today reported recently.
Are you ready to join us to Keep Growing Up

Sneak Peak into World’s Largest Flying Restaurant [Infographic]

First class cabin passenger in Emirates Airline enjoying her dinner. Photo-Emirates

How does a global airline like Emirates cater to the needs of its over 55 million customers? Here’s a neat infographic that gives you a glimpse into how Dubai’s flagship airline is able to meet and exceed its customer’s gastronomic requirements!
Emirates serves more than 100 million meals a year with the same attention to detail in First, Business and Economy Class. Catering for more than 55 million dine-in guests a year travelling to and from 144 cities across 6 continents, no one understands global culinary trends better than Emirates as it serves destination-inspired cuisine onboard the world’s largest flying restaurant.
With a catering investment of US$1 billion per year, Emirates runs a round-the-clock kitchen with 1,200 chefs based in Dubai whipping up 12,450 recipes. The finely-tuned operation caters 590 flights a day with authentic local cuisines giving customers a taste of the destination they are going to. The airline also works closely with 25 catering partners around the world to provide the same quality of food for its Dubai-bound flights.

Infographic: Emirate Airline – Catering to the World

Catering to the world. Infographic courtesy-Emirates

Global delicacies local flavour

Emirates’ focus on local flavour means it has food available from every region it flies to. Flights to Japan for example, offer authentic Kaiseki cuisine and Bento boxes served with Japanese crockery, cutlery and tea sets to ensure an unrivalled food experience on board.
The airline recently launched a new menu for its Australian routes inspired by the breadth of the country’s multicultural flavours and cuisines, after a 14-month process working in consultation with local chefs.
The new menu features a broad range of traditional local favourites such as minted lamb sausages. Reflecting Australia’s multiculturalism, the menu also includes Asian flavours, as well as Middle Eastern flavours and ingredients, catering to Emirates’ diverse passenger mix and representing its global route network.
To keep up with regional and seasonal food trends, Emirates changes its onboard menus monthly and continually reviews its recipes.
The varied menus on each route are also reflected in the bread baskets served on board. Flavoured breads or breads produced with a sourdough base are popular on European routes while parathas, pooris, and naan bread are served on all nine Emirates routes to India. On its Middle Eastern routes, customers get to enjoy Arabic bread – Markook – a very thin unleavened bread common in the region, and Manakesh which is either topped with Zaatar or Cheese.
In premium classes, meals are served on Royal Doulton tableware with Robert Welch cutlery specially designed for Emirates.

Global partners, best of local and artisanal produce

Emirates focuses on simple, well cooked dishes that emphasise fresh ingredients of the highest quality. The airline brings the finest products on board through long standing partnerships worldwide, and supporting local suppliers and artisans. This includes sourcing over 15,000 kilograms of Persian feta from the Yarra Valley in Australia each year. The olive oil served on board is exclusively from carbon neutral producer Monte Vibiano in Italy, a partnership that is now more than 15 years old.

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Understanding Kidney Tumours

Kidneys are two bean-shaped organs located on the left and right side of the spine. They sit against the back muscles in the upper abdominal cavity. They are responsible for the extraction of waste from the blood, balancing body fluids, formation of urine, and facilitating other important functions of the body.
Kidney tumours are tumours (or growths) on or in a kidney and are also known as renal tumours. They can be benign (harmless) or malignant (leading to cancer).

There are many forms of kidney tumours. Among the malignant types, the most commonly occurring type of kidney cancer is Renal Cell Carcinoma (RCC), accounting for 95% of cases in adults. The other types are Mesoblastic Nephroma (a congenital tumour, detected prenatally or after birth, before the age of 4), and Metastatic tumour or ovarian cancer. Among the benign forms of tumours are Renal Oncocytoma (a tumour made by special cells called oncocytes), Cystic Nephroma (a benign tumour that can look like an RCC and has cysts), Angiomyolipoma (most common form of benign tumours, though they can cause blood vessels to dilate and burst, leading to bleeding), Metanephric Adenoma (a rare tumour that can look like a papillary RCC) and Renal Medullary Fibroma (bland spindle-shaped or stellate-shaped cells that form a benign tumour).
Any problem with the kidneys is usually accompanied by symptoms such as difficulty in passing urine, blood in urine, pain in the abdomen, etc. However, not all kidney problems are caused by tumours. The tumours can be detected through:
1) Blood and urine tests
2) Imaging tests such as CT and MRI scans
3) Biopsy (removing a sample tissue of the kidney)
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Complaints Handling, Adverse Event Reporting, and Recalls call for an integrated approach

Medical device manufacturers work and operate in various regulatory systems whose requirements are different and not always consistent with each other. The new ISO version, the ISO 13485:2016, recognizes this fact. The disparate requirements of each regulatory system make it necessary for manufacturers to identify their roles, as well as the regulatory requirements for that role, and then incorporate them into their Quality Management System.
The various jurisdictions, however, deal with post-market device issues in diverse ways. Complaint management, Adverse event reporting and Recalls are three interlocking and interrelated processes that need to go into the QMS.
Corrective action and design changes, which are supporting QMS processes; also need to complement these three processes. And then, the regulatory requirements, which usually involve areas such as recordkeeping and reporting, also come in.
A course on how to implement an integrated QMS

GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, is organizing a highly educative and valuable learning session on these primary and secondary QMS processes and the way they need to be understood and implemented in relation to the US, EU, and Canadian regulations.
Dan O’Leary, who is President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, which focuses on analytic skills and a systems approach to operations management, will be the Director of this two-day seminar. Dan brings more than 30 years’ experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs.
Want to benefit from Dan’s rich experience and want to understand the way in which to implement an integrated QMS in which the various aspects of complaints, adverse reporting and recalls are built? Please register for this seminar by visiting Complaints Handling, Adverse Event Reporting, and Recalls call for an integrated approach. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.
Alignment with the FDA’s QMS

The extent of its alignment with the FDA’s Quality Management System (QMS) requirement is one of the highlights of the final version of the ISO 13485:2016 standard, which has now become available. The degree of alignment set out in 2016 version of 13485 may be significantly higher than that of the previous version of 2003; yet, there still do exist a few points at which it deviates from the FDA’s QMS. Companies that should comply with this standard have to keep this in mind.
Now that the ISO 13485:2016, the Medical Device Single Audit Program (MDSAP), and the new EU Medical Device Regulation have been introduced; companies need to update their QMS and integrate all of the elements if their implementation has to be effective and compliant. At this two-day session, Dan will provide the tools that the participants will need for this.

Upset man lost in thought having received bad news from his doctor

The agenda of this learning session will be the following:

• The Regulatory Structure
• FDA QSR
• ISO 13485:2016 and regional variants
• ISO 14971:2007 and regional variants
• Implementing MDSAP
• The EU Medical Device Regulation
• Servicing
• Identification of problems
• Servicing data analysis
• Input to the complaint process
• Complaints

Identifying complaints

• Evaluating complaints
• Investigating complaints
• Complaint data analysis
• Input to the corrective action process
• Input to the risk management process
• Corrective Action
• Developing the process
• Analyzing product and process information
• Determining subsequent actions
• Input to the design process
• Input to the risk management process
• Design and Design Changes
• Determining the need for a design change
• Documenting design changes
• Design change verification and validation
• Input to the risk management process
• Input to the pre-market submission process
• Risk Management
• ISO 14971:2007 and regional variants
• Incorporating post-market information
• Updating Pre-market Submissions
• US – The 510(k) guidance
• EU – Technical files and design dossiers
• Canada – License changes
• Adverse Event Reporting
• US – MDR
• EU – Vigilance Reports
• Canada – Mandatory Problem Reporting
• Recalls
• US – Corrections and Removals
• EU – Field Safety Corrective Actions
• Canada – Recall.

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Health care in the United States

Health care in the United States is provided by many distinct organizations.^[1] Health care facilities are largely owned and operated by private sector businesses. 58% of US community hospitals are non-profit, 21% are government owned, and 21% are for-profit.^[2] According to the World Health Organization (WHO), the United States spent more on health care per capita ($8,608), and more on health care as percentage of its GDP (17%), than any other nation in 2011.
64% of health spending was paid for by the government in 2013,^[3][4] funded via programs such as Medicare, Medicaid, the Children's Health Insurance Program, and the Veterans Health Administration. People aged under 67 acquire insurance via their or a family member's employer, by purchasing health insurance on their own, or are uninsured. Health insurance for public sector employees is primarily provided by the government in its role as employer.^[5]
The United States life expectancy of 79.8 years at birth, up from 75.2 years in 1990, but only ranks 42nd among 224 nations, and 22nd out of the 35 industrialized OECD countries, down from 20th in 1990.^[6][7] Of 17 high-income countries studied by the National Institutes of Health in 2013, the United States had the highest or near-highest prevalence of obesity, car accidents, infant mortality, heart and lung disease, sexually transmitted infections, adolescent pregnancies, injuries, and homicides. On average, a U.S. male can be expected to live almost four fewer years than those in the top-ranked country, though notably Americans aged 75 live longer than those who reach that age in other developed nations.^[8] A 2014 survey of the healthcare systems of 11 developed countries found the US healthcare system to be the most expensive and worst-performing in terms of health access, efficiency, and equity.^[9]
Americans undergo cancer screenings at significantly higher rates than people in other developed countries, and access MRI and CT scans at the highest rate of any OECD nation.^[10] Diabetics are more likely to receive treatment and meet treatment targets in the U.S. than in Canada, England, or Scotland.^[11][12]
Gallup recorded that the uninsured rate among U.S. adults was 11.9% for the first quarter of 2015, continuing the decline of the uninsured rate outset by the Patient Protection and Affordable Care Act (PPACA).^[13] A 2012 study for the years 2002–2008 found that about 25% of all senior citizens declared bankruptcy due to medical expenses, and 43% were forced to mortgage or sell their primary residence.^[14]
In 2010 the Patient Protection and Affordable Care Act (PPACA) became law, providing for major changes in health insurance. Under the act, hospitals and primary physicians would change their practices financially, technologically, and clinically to drive better health outcomes, lower costs, and improve their methods of distribution and accessibility. The Supreme Court upheld the constitutionality of most of the law in June 2012 and affirmed insurance exchange subsidies in all states in June 2015.[15

keep enhancing Quality management system
 

Professionals Involved in The FDA’s Tougher Import Rules for 2017

Of late, the FDA and the Customs and Border Patrol Service (CBP) have become increasingly agile, smart, sophisticated and demanding when it comes to the submission of information and adherence to government procedures from importing firms. The FDA and the CBP can delay, detain or refuse shipments of firms do not properly execute an import and export program.
The CBP’s new Automated Commercial Environment (ACE) computer program has carried out several changes to the process of import logistics and information reporting for FDA regulated products. The alternatives to noncompliance with the requirements of the ACE program: A shipment may be stopped before it is even loaded at the foreign port. Ships that refuse to or fail to use the ACE program also carry a fine of up to $10,000 for every offense.
Or, when the FDA detains a company’s product; it will begin an expensive and time-consuming legal process. Since the agency expects companies to have the import coding information accurate and up-to-date; companies that do not have a clear understanding of the automated and human review process can expect to have their shipments detained.
One more area that poses a challenge for importers is when the FDA decides that they should bring the products back to the port of entry after they received a release but cannot locate the product that has been sold. In such a scenario, companies that go through this process attract a fine that is three times the value of the shipment. This is in addition to the other adverse legal concerns and strategies that are attached to this action. Overall, the costs of not complying with the FDA’s guidelines on imports can be very high and can carry very expensive consequences for importing companies.
There are positives, too

However, not all is lost. The FDA is implementing the Voluntary Qualification Importer Program under the FDA Food Safety and Modernization Act. Aimed at incentivizing importers who instill a high degree of confidence about the quality of food they import; the nub of this plan is that it establishes an FDA-supervised, fee-based program that expedites the review and importation of foods from importers who can show a heightened level of control over the safety and supply chain aspects of the imported food items.
Another convenience that the FDA offers is export certificates. Obtainable for a modest fee; these certificates may give an importer a competitive advantage in foreign markets. An FDA export certificate is actually a requirement by a few foreign governments.
Full learning on the FDA’s new import rules for 2017

All the aspects of the new FDA import rules will be taught at a highly absorbing two-day seminar that GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, is organizing.
Casper Uldriks, an ex-FDA Expert and former Associate Center Director of CDRH, Olsson, who has served as a senior manager in the Office of Compliance and an Associate Center Director for the Center for Devices and Radiological Health, where he developed enforcement actions and participated in the implementation of new statutory requirements for FDA; will be the speaker. to enroll for this course, please visit Professionals Involved in The FDA’s Tougher Import Rules for 2017. This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.
Casper will impart learning on all these topics and on the ways by which to avoid these and related common problems that can become terribly expensive when a proper strategy and plan for dealing with them are not implemented. Importers need to put in place an established and effective business planning, whose ways will be shown at this seminar. A bonus of this course is that the speaker will also include tips on how to understand FDA’s thinking and offer anecdotal examples of FDA’s import program idiosyncrasies. He will also explain how to deal with common problems, such as returns for repair, importing QC samples, and investigational products.
Are you ready to join us to Keep Growing Up

Drug dissolution testing and establishing plasma drug levels in humans

Dissolution testing is a very important tool that determines and help understand the performance and effectiveness of oral solid dosage forms. It is significant for the field of medicine because if a drug has to be effective, it must be released first from the product form, and it should then be allowed to get dissolved in the gastrointestinal fluids. This is the first step that leads to the next important phase, that of the dosage’s absorption into the bloodstream. This points to the fact that dissolution from the dosage form is a major determinant of the rate and extent to which the drug gets absorbed by the body.
Drug dissolution testing is very important during the development of drugs and drug formulations. It helps to determine if the right concentration of the drug reaches the desired or expected locus of action. This makes the investigation of the factors which affect drug absorption into the human blood flow when a drug product is taken orally important.
The usual method of measurement of drug absorption is in vivo, or, the body of a living being such as a human or animal. Time blood plasma concentration profiles of drugs after oral administration constitute an important in vivo parameter. In-vitro investigations are carried out for identifying the parameters involved in drug absorption. These are investigations that are conducted in a controlled and simulated environment that resembles biological conditions closely.
Thorough learning of drug dissolution

An important seminar from GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will offer valuable learning on all the aspects of drug dissolution testing and explain the ways of establishing plasma drug levels in humans.
At this two-day seminar, Dr. Saeed Qureshi, who has worked as a research scientist with Health Canada and is an internationally known expert on the subject whose expertise spans the areas of drug dissolution testing, pharmacokinetics, biopharmaceutics and analytical chemistry as related to animal and human studies for developing and evaluating pharmaceutical products; will be the Director.
In order to gain the benefit of learning from this world-renowned expert, please enroll for this seminar by visiting Drug dissolution testing and establishing plasma drug levels in humans. This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.
All aspects of drug dissolution and establishing plasma drug levels

This seminar will provide its participants a unique opportunity to learn scientifically valid drug dissolution testing and establishing plasma drug levels. Lab personnel take several approaches to conduct dissolution testing using different apparatuses and methods. This makes section of an appropriate apparatus and method confusing and challenging. Dr. Qureshi will offer relevant pharmacokinetics and physiological background that is aimed at making this choice easier and intuitive. He will use simple and clear language in helping participants understand how to select or develop a dissolution method. He will describe the theoretical aspect of the drug dissolution testing, including method development, in detail. He will explain the pros and cons of different approaches.
Another important area that Dr. Qureshi will address is in vitro-in vivo correlation (IVIVC). He will address the particular issue of the use of the concepts of convolution/deconvolution and IVIVC in providing an estimate/prediction of expected drug levels in humans through drug dissolution testing. This approach has met with limited success. Dr. Qureshi will explain the reasons for this and suggest alternative approaches and will offer an explanation of the underlying scientific principles involved in convolution, deconvolution and IVIVC techniques with simple practical examples. He will describe a unique and simple approach based on convolution technique using spreadsheet software.
He will show in vitro drug dissolution testing and convolution/deconvolution techniques for predicting plasma drug levels using the principles of pharmacokinetics and physiology. Dr. Qureshi will cover the following main areas at this seminar, with its relevant subtopics:

• Physiological and Pharmacokinetic Principles
• Drug Dissolution Testing
• Linking Dissolution Results to Plasma Drug Levels.

Personnel who work in various levels of the areas of Pharmaceutical Development, setting up analytical methods (pharmacopeial, regulatory or in-house developed), R & D (both analytical and formulation), Project Management, Quality Control, Quality Assurance, and Regulatory Affairs will benefit enormously from this learning.
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