Health on the menu at Nature’s Goodness in Welland

Who has spent three years preparing to head out on her own after a career working in the health food industry.

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Health-conscious individuals may want to take a trip down West Main Street.

Nature’s Goodness Health Foods and Wellness opened this week at 98 West Main St., kicking off seven days of prize giveaway running until Saturday as part of the store’s grand opening. Establishing a shop of her own — specializing in a full range of vitamins, supplements, essential oils, organic foods and more — has long been the dream of owner Sarina Giansante, who has spent three years preparing to head out on her own after a career working in the health food industry.

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“I thought I would finally give it a shot,” said Giansante, who is paring the products offered on her shelves, ranging from organic and natural beauty and bath products to dietary supplements, with in-house organic tea and coffee products. She has set up a seating area, replete with Himalayan salts to provide guests a relaxing environment to enjoy their beverages, such as organic cappuccinos, and as she moves forward, organic food offerings.

The field is a passion for the certified biofeedback technician, who aims to find natural remedies for ailments that might otherwise require medication.

Facts that Everyone Should Know About Fda Regulation

Many cultures outside the US use these for recreational purpose with the approval of society and governments, with there being nothing illegal about them.

The Food and Drug Administration (FDA) is the US’ regulatory agency for a variety of products that concern the health of their consumers. The FDA regulates everything concerning food, medicine, medical devices, veterinary products and cosmetics, as well as products that emit radiation. In addition to directly regulating all these through its set of regulations, the FDA also encourages innovation in the products and processes of products in these areas.

For the average American consumer, the FDA is a protective agency that ensures that the foods and medicines consumed by Americans is of world class standards of quality and hygiene. It is also perceived as the agency that stalls bioterrorism by ensuring strict vigilance over this nefarious activity. All these make the FDA a source of comfort for many consumers in the US. After all, when Europe was shaken by the thalidomide scandal of the 1960’s, the FDA, under the stewardship of Frances Oldham Kelsey, showed exemplary alertness and diligence by not allowing it to be sold in the US because it failed to convince this woman of the extent of its standards into this product. The result: prevention of birth defects in potentially thousands or even hundreds of thousands of children, a malady that affected an entire generation in Europe.

To the manufacturers of the products that the FDA regulates, however, it is a stringent regulatory body that is highly adamantine in its approach and is unsparing of anyone. It is often seen as an arm chair critic who doesn’t have to get to the thick of action and just sits on a high pedestal, dictating terms without allowing for the slightest latitude in its strict regulatory requirements.

What is the truth about the FDA? Well, somewhere between.  Let us get down to understanding a few facts about the FDA which will help us understand why it is so stern in setting out standards for regulations and implementing them.

It only does its duty as a health watchdog

The FDA’s primary goal is to ensure public health and to foster innovation and cost-effectiveness in the production of health products. It leaves no stone unturned in its quest to ensure this. This is why, many times, it gets down to hairsplitting details about the processes or composition of many products. It is also not easily convinced about the processes and methods adapted by companies, which is why it has its set of standards that are common to everyone in the respective industry.

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Only companies that strictly adhere to the requirements can expect to have their products approved for marketing. When companies fail to meet the requirements of the FDA, they have to carry out a series of often painful and tedious corrective measures. If organizations fail to do this to the FDA’s satisfaction, they can face strict consequences. Many organizations have been penalized to an extent where it has impacted the business. Companies having to shut down their business also has not been unheard of.

Other facts everyone should know about FDA regulation

If all these are an overview of the functioning of the FDA, then, there are many other facts everyone should know about FDA regulation. Let us start with a bit of history to understand how regulation is inbuilt into the FDA:

Although created in 1906, it gained more legislative teeth with the passage of the Federal Food, Drug and Cosmetic Act of 1938. This legislation came into being after a tonic, although legally marketed, killed over a hundred people, including many children. This was when the FDA’s system underwent an overhaul with added emphasis on regulation.

Among the other facts everyone should know about FDA regulation, there is the financial aspect of the FDA: With a budgetary allocation of well over $ five billion a year, the FDA has oversight of the consumption by the general American public of medical products, food and tobacco, whose value runs to over $2.5 trillion.

Some of the other facts everyone should know about FDA regulation

Now, some of the other facts everyone should know about FDA regulation:

  • With the exception of some items such as meat, poultry and a few egg products, the FDA directly regulates nearly three fourths of the U.S. food supply
  • The FDA approves close to 20,000 different varieties of prescription drug products for The number is over a third of that, more than 6,000, for medical device product categories. When it comes to animal drug products, the FDA has a hand in the approval of around 1600 varieties. With relation to biological products, the number is around 340
  • Products whose worth adds to about a fifth of all the money Americans spend are regulated by the FDA
  • Although the FDA oversees more than a humungous number of tobacco products-85,000; e-liquids are not included in this list
  • The FDA attaches extreme importance to labeling of medical and other products it regulates. The labeling requirements are very strict and companies that make false claims are hauled up seriously and heavy penalties are slapped on them. Yet, it is estimated that there is a margin of error of as much as 20 percent when it comes to nutritional facts provided on labels.

The FDA and the touchy area of food supplements

The FDA does not regulate food supplements. This is among the facts everyone should know about FDA regulation. It is because of the subjective nature of many food supplements. Many supplements sold in the US and consumed by Americans as food supplements could be put to different uses in the country of their origin. Mood altering drugs are a prime example. Many cultures outside the US use these for recreational purpose with the approval of society and governments, with there being nothing illegal about them.

However, the FDA’s stringent approval process could prevent some products from being labelled purely as drugs because of the effect on the human mind or body and because of the process employed in their production. The FDA has no say in the way these products are prepared, which is another reason for which the FDA may not regulate food products.

The matter with food supplements is that consumers can use them at their own risk. The FDA does not take responsibility for the safety of these products and leave it to the consumer. It is left to the individual consumer. If she has a high comfort level in using these, it is left to the user.

https://www.fda.gov/AboutFDA/Transparency/Basics/ucm553038.htm

https://www.fda.gov/aboutfda/whatwedo/default.htm

https://www.self.com/story/ways-the-fda-impacts-your-everyday-life

https://www.labelcalc.com/nutrition-facts-labels/nutrition-facts-label-size-requirements-what-food-manufacturers-need-to-know/

https://www.stuffyoushouldknow.com/podcasts/why-doesnt-the-fda-regulate-herbal-supplements-transcript.htm

The [Ultimate Guide] To Medical Device Inspection

I want to present the ultimate guide to medical device inspection, which I believe is going to live up to just what I am calling it: the ultimate guide to medical device inspection.

A medical device inspection. Ah! Is there a more dreaded exercise for a medical device manufacturer? If I were given a choice between taking up the world’s toughest rated examination and facing a medical device inspection, I would gladly opt for the former. A medical device inspection should rank right there ahead of the most difficult examination or task.

Alright. We knew this fact all along. So, why should I intimidate you by casting such aspersions on a medical device inspection? Fact is, a medical device inspection’s stringency is a little overrated. Am I not contradicting myself? On the surface, yes, but scratch a bit, and you will realize the truth of what I am saying.

Yes, medical device inspections are extremely difficult to the point of being scary. But the fundamental question is, for whom? A medical device inspection is a difficult one for only those who are unprepared for it. In other words, a medical device inspection is just like a highly rated competitive exam: it is tough if you are unprepared and manageable if you are prepared.

So, in what way can a medical device manufacturer prepare for a medical device examination? I want to present the ultimate guide to medical device inspection, which I believe is going to live up to just what I am calling it: the ultimate guide to medical device inspection.

The basis to a medical device inspection is just one mantra: prepare, prepare and prepare. I already know it and I don’t need you to tell me this, you may say. But how to prepare and what to prepare for is the question. I will try to make my ultimate guide to medical device inspection as comprehensive as I can and will try to shed as much light on as many areas of it as I can, while trying to keep it simple.

Conceptualization

Let us begin at the beginning. Some medical devices are designed newly. Many build on what is already there in the market and some are completely off the block. The first step to my ultimate guide to medical device inspection is to understand this aspect of a medical device. Is your device a new one or is it being developed based on an existing device’s core? Many devices alter or extend an existing one to stretch its uses to a new or untapped market. The entire nature of the medical device inspection can depend on this nature of the medical device. So, classifying your medical device into its right slot is the first step in this ultimate guide to medical device inspection. Conceptualizing what your medical device is like is half the work done.

Regulations!

Regulations are at the heart of medical device inspections. All inspections look primarily for the extent of compliance to regulations. In perhaps no other industry is regulation of such vital importance than in the field of medical devices. Getting the regulations right is the foundation of a successful medical device inspection and quite easily qualifies in the ultimate guide to medical device inspection. Companies have enormous resources in the form of FDA literature (or that of other regulatory bodies if the product is marketed in those jurisdictions) and expert guidance.

My sincere exhortation: please do not hold back your purse strings in this most important of areas. If you try to economize and satisfy yourself that you have saved a few dollars here, think of what you will be required to cough up if your device fails to meet regulatory standards. The penalties are of such order that you may even have to shut shop like so many others that have met the same fate. Make sure the regulations are adhered to each and every stage. The consequences of staying compliant are simply too many and all of them are of a positive nature.

Keep a very sharp eye on Design Controls

Design Controls constitute the next point in the ultimate guide to medical device inspection. This is another of the areas in which the FDA is unsparing when it comes to penalizing medical devices companies that don’t meet the requirements. Learn all the intricacies of Design Controls and understand the criticality of documentation in Design Controls. In addition to helping you to meet regulatory standards, it also makes your own life easier. Documentation enables you to quickly track any activity that the inspector may want to examine. It helps you guarantee and assure your activity at every stage. This diagram is neatly indicative of what the FDA expects the Design Control flow to be like:

This link https://goo.gl/5Yn6MF has more on this topic for your reference

If You Haven’t Heard Yet, Quality Management Is [Your Best Bet] to Grow

The business may be a century old or it may have started out recently. Quality is thus inherent into the company’s product lifecycle and has to be ensured throughout the existence of the product and the business.

What are the parameters that set organizations on the growth path? Is it the market size? Is it the people? Is it the system or the technology? While all these are crucial components for an organization, the underlying element in all these is Quality Management. Quality Management is that one core ingredient that steers organization through its business and ensures its growth. If you haven’t heard yet, Quality Management is your best bet to grow.

How? Simple: there is no substitute for quality when it comes to the organization’s ability to deliver. Quality is the soul of a business. Quality is at the root of an organization’s performance. Without quality products or services, the organization loses its reputation in the market. A business that loses its name loses everything.

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Cannot assure quality? Be prepared to lose customers

These consequences of not having quality products or services are understandable because when customers feel that their quality expectations are not being met, they switch over their loyalties at the snap of a finger. This departure of the customer base can happen at any time. The business may be a century old or it may have started out recently. Quality is thus inherent into the company’s product lifecycle and has to be ensured throughout the existence of the product and the business.

This process of building a business into which quality inheres and is present throughout the lifecycle is symbolized by the concept of Total Quality Management or TQM. TQM is an approach whose concepts help organizations reach their quality goals by taking their unique business and product-related aspects into consideration. It is a system in which the concepts can be applied during all phases, as well as all situations of the business: in times of prosperity, in times of stability, in times of flux, as well as in times of adversity.

Overall improvement into the process

TQM suggests an organized and logical manner in which to apply concepts and principles of quality to bring about improvements in the product or service. TQM is about developing a system in which all the processes come into play in an organized and harmonious manner. It is all about making the systems as foolproof as one can. If a fault is present, it has to be so in the system and not in the line employee. In other words, TQM is all about putting in place a process-oriented, rather than a people-oriented Quality System.

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Total Quality Management is comprehensive from another perspective: in involving the employees of the organization. Applying TQM is not limited to the top brass of the organization. This principle requires the involvement and participation down to the last level of employees.

Also, for quality to come about, the active involvement of not only the employees, but also those involved in the organization externally, such as consultants and contractors, is as crucial.

The customer at the core

The concept of Quality Management is built placing the customer at the center of the policy implementation. The concept of TQM is built around the belief and fact that the customer is the heart of a business. This is natural, because if there is no customer, there is no business. A customer can exist without a business, but can a business exist without a customer? No.

By placing the highest and maximum emphasis on the customer, Quality Management works around this core component of the business. Quality is not a standalone parameter. It is always achieved and measured in terms of what the customer thinks about it. Quality is of no consequence unless the customer thinks and feels that her quality requirements and expectations have been met. Quality is something that can only be assessed in relation to this core.

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Benefits of implementing Quality Management

The concept of Total Quality Management is built in a manner that makes it all encompassing in its sweep. From both the perspectives of the what each employee is expected to do, to what areas of quality the organization can bring about by modifying their behaviors and attitudes, TQM is an all-round tool. By instilling these aspects into the product or service, organizations are put on the growth path with utmost certainty. Having a Quality Management plan in place ensures the following:

  • There is drastic, micro level improvement in the overall functions of the organization
  • It ensures that the quality expectations of the customers are not only met, but at times, exceeded as well, since the customer is the focal point of a TQM system
  • Implementation of TQM into the lifecycle of the organization’s product or service brings costs down since it is aimed at reducing the errors
  • This brings about a palpable rise in the organization’s name in the market.

All these point to the clear and unmistakable role of quality to organizations. If you haven’t heard yet, Quality Management is your best bet to grow.

https://psychology.iresearchnet.com/industrial-organizational-psychology/organizational-development/total-quality-management/

http://pubs.sciepub.com/ajie/1/3/2/

https://www.researchgate.net/publication/267271713_Total_Quality_Management_as_a_Paradigm_of_Business_Success

https://www.strategy-business.com/article/16188?gko=52d0b

How to Handle Every Accounting Courses Challenge with Ease Using These Tips

This challenge can be handled by choosing the course with the right offering and from the right online learning platform.

Accounting is a profession that attracts talent from around the world. It is a sought-after profession in many parts of the world. Accounting systems and practices are different in different parts of the world, which makes uniform and standardized learning both futile and impractical. Regulatory practices are at the core of accounting and auditing. Noncompliance to these practices has resulted in serious frauds and money laundering among some of the reputable organizations of the world.

It is to help prevent such occurrence that proper and professional training is a must for accounting. Well-designed accounting courses are the solutions to this issue. Accounting courses help practicing and upcoming accounts professionals to understand the ways by which to adapt the right accounting practices that are compliant with the regulations for the industry. This makes the choice of accounting courses a very vital element of accounting.

Want to understand how to handle every accounting courses challenge with ease? Using these tips should be of use:

Identifying the training needs

The main point of how to handle every accounting courses challenge with ease using these tips, learn to identify the training needs. This is the foundation for accounting courses. The organization or individual has to first get a proper and thorough idea of what training is needed. Some of the questions it can examine can include:

  • What area of accounts does one need training in?
  • What is the training going to cover?
  • Who is going to offer the training and through what medium?

Examining these questions can go a long way in helping to handle the challenges associated with accounting courses.

Choose the best suited mode of training

One of the main challenges of handling accounting courses is the choice of the right medium of learning. Unlike subjects like chemistry or biology, accounting courses do not have to bring the student and the teacher together at one location in close physical proximity to each other. Accounting courses are taught through various means. It is no longer necessary to attend regular classrooms to gain proficiency in accounting. Accounting courses are offered online. This challenge can be handled by choosing the course with the right offering and from the right online learning platform.

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Yet, if an organization or individual feels after making an evaluation of the mode of learning feels that having the course taught in person can be more useful, it can go ahead. It is all a matter of its own convenience and suitability. It completely depends on the course content, the relevance of the course, the number of people taking it up, the feasibility of the course and factors such as these.

What should those who want to choose a course in accounting look for?

In explaining how to handle every accounting courses challenge with ease using simple tips, let us look at what course to choose. With so many courses available online or in person and with so many organizations offering trainings, it can sometimes end up confusing the person or organization that wants to take up the accounting course.

This again can be a challenge that can be overcome with ease. Make a thorough investigation of the course content, the online learning platform offering the course and the experience and reputation of the expert. This should help resolve this challenge without too much difficulty.

Set and evaluate the outcomes

Another of the suggestions for how to handle every accounting courses challenge with ease using these tips includes setting goals for the learning and evaluating the outcomes. This is a very critical aspect of accounting learning challenges. The organization should talk it out with the trainer about the learning needs and identify the goals. Once the objectives of the learning courses are set, the organization should help the employees go ahead with the learning.

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The next step is to evaluate the outcomes once the learning is complete. This will help to measure the outcomes of the learning, which is really an important tool. There is little or no point in teaching accounting courses when there is no assessment of the impact the learning has had on the participants.

Measuring tools can be employed and mapped against the goals. With tools such as this, organizations can get a clear idea of what purpose was served at the training.

https://www.efrontlearning.com/blog/2017/04/common-training-challenges-solutions.html

https://economia.icaew.com/opinion/october-2014/top-three-challenges-facing-accountants-today

6 artificial flavorings with cancer-causing properties – (FDA bans)

The announcement from the U.S. Food And Drug Administration carries a yawn-inducing title: “FDA Removes 7 Synthetic Flavoring Substances from Food Additives List.” It sounds like a regulatory move aimed at food-makers, and it is. But it’s one that has a slightly alarming backstory: The FDA is effectively banning these artificial substances because they have been shown to cause cancer in animals.

Under a provision of the Federal Food, Drug, and Cosmetic Act known as the Delaney Clause, the FDA cannot approve ingredients for use in food that have been found “to induce cancer in humans or animals at any dose.” Six of the substances “delisted” (effectively, banned) by the FDA have been found to cause cancer in animals exposed to very high doses. The seventh ingredient was delisted because it is no longer used at all by the food industry, the FDA says.

The six other artificial flavorings — benzophenone, ethyl acrylate, eugenyl methyl ether, myrcene, pulegone, and pyridine — are now no longer permitted for use in food, even though the FDA states that previous testing found “they do not pose a risk to public health under the conditions of their intended use.” Eager to not incite any kind of a panic, the FDA is stating the animals that developed cancer did so after exposure to very high levels of these flavorings — much higher doses than any human would likely ingest: “The FDA is only revoking the listing of these six synthetic flavorings as a matter of law. The FDA has concluded that these substances are otherwise safe.”

This latest FDA mandate comes on the heels of two other moves away from non-natural ingredients: In January, Dunkin’ announced it would phase out artificially derived coloring in its products by the end of the year, and last month, McDonald’s pledged that it would remove all artificial colorings and preservatives from its classic burgers (minus those pesky pickles). Taken together, these individual developments suggest the movement away from artificial colorings, preservatives, and flavorings is gaining serious traction.

FDA Viral news related to Health every one has to know https://goo.gl/tVE3WP

This is How SOX Compliance will Look like in the [Future]

It is a lot easier to trace transactions today than they were a decade ago.

Formally known as the “Public Company Accounting Reform and Investor Protection Act” in the US Senate and as the “Corporate and Auditing Accountability and Responsibility Act” in the House of Representatives, Sarbanes Oxley (SOX) is a landmark legislation that the American Congress passed in 2002. Named for the sponsors of this Bill, senators Paul Sarbanes and Mike Oxley, it was passed in the wake of the financial scandals of huge American corporations that rocked the American economy, such as Tyco, Enron, WorldCom, Arthur Andersen and Global Crossing among others that shook investor confidence.

Effective from 2006, what SOX does is to mandate laws for strict accountability from firms that do business in the US. This included not only American, but foreign firms as well. The aim of SOX was to stipulate a broad and strong accounting framework for all companies that do business in the US. SOX consists of eleven sections. Among its most important provisions are the establishment of a Public Company Accounting Oversight Board (PCAOB) under the Security and Exchange Commission (SEC) and the designation of civil and criminal penalties for companies that are found to be noncompliant and violative of the provisions.

Making companies more accountable financially

The crux of the requirement is for companies to establish a framework for financial accounting which will enable them to generate thoroughly verifiable financial reports whose data source should be traceable. The data should also have electronic information of all details of access, such as who accessed what data, when it was done, what was done during the access, and what action was carried out.

Since SOX compliance is mandatory for most companies, how does it feel to comply with the provisions of this Act? If we are asked to speculate what SOX compliance will look like in the future, we need to look at it from the standpoint of technology. This is because technology is inseparable from accounting. Most transactions are electronic in nature. Technology has taken us to a point where manual recordkeeping and accounting are almost totally obsolete.

This is how SOX compliance will look like in the future

In this backdrop, prognosticating how SOX compliance will look like in the future is tentative. This is because of the changing nature of technology. Technology, as we are aware, keeps changing by the minute. As more technological advances are made, it is only natural to expect them to be incorporate into technology-dependent and technology-propelled activities that SOX requires. It is a lot easier to trace transactions today than they were a decade ago.

Technology, as we are all aware, is totally unpredictable. Even as SOX-compliant systems start getting used to a technology, updates and developments into it could trigger the need for more amendments. An unexpected development can throw the whole adaption process asunder.

Uniqueness which could make it the ultimate technology https://goo.gl/kNBRGA