Investigators to Review CAPA and What you Should do to Prepare

How your company can use that same document to increase the likelihood of a positive outcome during the inspection.

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Fremont, CA: Compliance4All, a leading provider of professional training for all areas of regulatory compliance, is organizing a webinar on January 11, 2019. The topic of the webinar is “How FDA Trains its Investigators to Review CAPA and What you Should do to Prepare”, and the speaker is Jeff Kasoff

To enroll for this webinar, please visit https://www.compliance4all.com/control/w_product/~product_id=502272LIVE?LI-SEO

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Year after year, CAPA is the subsystem cited most frequently during FDA inspections. During an inspection, FDA personnel will take a great deal of time reviewing your company’s CAPA system. What will they look for? This session will discuss techniques used by the FDA to review your CAPA system. The documents used by FDA to train their inspectors to review your CAPA system will be explained, some of which you may not be familiar with.

Also contained in this session will be a section-by-section summary of the CAPA subsection of the QSIT, the document by which FDA inspectors operate during an inspection, as well as how your company can use that same document to increase the likelihood of a positive outcome during the inspection.

  • Documents Used by FDA Inspectors
  • Investigations Operations Manual (IOM)
    • CAPA Implications
    • Recommended Methods of Compliance for each Requirement
  • CPG Manual 7382.845
    • CAPA Implications
    • Recommended Methods of Compliance for each Requirement
  • QSIT Manual
    • Description of each CAPA Inspectional Objective
    • Recommended Methods of Compliance

Positive outcome during the inspection http://bit.ly/2CUFWK8

You Will Never Believe These Bizarre Truth Behind Food And Beverages

Further, out of these, nearly 20 million, one in 16 Americans, visit a full-service restaurant on any given day.

The food and beverages industry, a global one, is an interesting bag of surprising and often contradicting facts. The food and beverages industry is a really global one, meaning there is almost no place on this planet that this industry does not cover. You are as likely to find a food joint in Mongolia as you are in Mozambique. The reason is simple: we can live without many things, but not without food. Any surprise that this industry is a giant, valued at a few trillion dollars globally?

The food and beverages industry in the US is characterized by several interesting facts. Many of these could be in the positive and some, in the negative. Whether it is about the positive or the negative factors one is talking about, there is no doubt about one thing, which is that the food and beverages industry is one filled with very interesting facts. Let us take a look at some of these:

One in seven Americans eats fast food everyday

It is estimated that as many as 50 million Americans consume fast food every single day, without a weekend or a vacation! This is more than the population of many countries. The most important reason for this is the quickness and convenience associated with fast food. Further, out of these, nearly 20 million, one in 16 Americans, visit a full-service restaurant on any given day. Yet, surprisingly, this is the same percentage of Americans who have been eating outside for the past 15 years!

Millions of children eat fast food in the US

As many as a third of the children aged between two and nine years eat fast food daily in the US. The media could be playing a part in this because it is estimated that on average, the American child is exposed to three to five ads for fast foods every single day. This rate of consumption is cause for some worry for policy makers and health experts, although one silver lining could be that children are more aware of the importance of eating clean food.

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American cuisine is still the top hit

Among the millions of Americans who make up the market for the food and beverage industry, four fifths of all food consumed in hotels in the US is American. While the cuisines of most other countries are still popular, this figure points to the overwhelming preference for American food by those who eat outside. Want to know which the least preferred cuisine is? It is Scandinavian and Nordic food, which is consumed by only two percent of those eating outside. Adding to the interesting facts about the food and beverages industry is the point that a high proportion of Americans like their food to contain local, fresh ingredients and flavors.

Americans eat the most outside during warm weather

Call it a case of sunny binge or the lethargy of getting out of home during the cold seasons; it is a fact that Americans eat more outside during the warm seasons.

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The fast food industry is highly concentrated

While there are hundreds of players in the fast food industry, an interesting fact about the food and beverages industry is that almost all the food consumed by the Americans is sold by only a handful of companies such as PepsiCo, Kellogg and General Mills and a handful others.

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Information about the food is an important factor

Another of the interesting facts about the food and beverages industry is that for Americans who eat outside, information about the food’s nutritional content is a major factor when it comes to eating outside. This is followed by how many options the restaurant offers for low calorie foods.

Want to recommend a restaurant to a friend? Think again!

Surprising as it may sound, one of the truly interesting facts about the food and beverages industry is that a friend’s recommendation or online suggestions are the least important factors that motivate people to go out and dine at restaurants. The top factors are still the quality of food, followed by the time taken to travel to the restaurant and the quality of service.

Move towards cleaner food

The move towards cleaner food by the industry as a whole is one of the other interesting facts about the food and beverages industry. With children themselves becoming aware of the need for cleaner food, as we just saw, does it surprise that chains such as McDonalds are making conscious efforts towards preparing and selling cleaner food?

Cleaner food

Nutritional labels can be deceptive

Facts about nutrition that are ubiquitous on food labels are misleading. They are almost never 100% truthful. While the facts relating to the percentage of the ingredients may not be fully wrong, the claimed benefits can be off target. Isn’t is one of the interesting facts about the food and beverages industry that in this information-driven society, there is still a lot of scope for manipulation?

Now, the most unpleasant interesting fact about the food and beverage industry…

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America leads in food waste

Whether it is at homes or in restaurants, especially in the latter, the proportion of food that is wasted is extremely high. As much as two fifths of all the food eaten in restaurants ends up in the waste baskets. One of the main reasons for this factor is that what is left behind in the plates is insufficient to make a full meal of, as a result of which it finds its way to the bin. When the food wasted in transport and while being cooked is accounted for, this amounts to an average of $2,000 being spent on just wasting food by every American during a year.

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This gives North America the dubious distinction of being the top waster of food anywhere in the world. This region wastes around 95-110 kilos of food per person per year, which places it several notches ahead of the region at the other end of the list: sub-Saharan Africa, which wastes around six to seven percent of this ratio. This wasted food can have extremely serious consequences for the rest of the world. While being responsible for a carbon footprint of about three gigatons, this wasted food also consumes as much as 28% of the world’s agricultural area!

https://www.weforum.org/agenda/2015/08/which-countries-waste-the-most-food/

http://www.fao.org/docrep/018/i3347e/i3347e.pdf

https://www.theatlantic.com/health/archive/2012/08/how-40-of-our-food-goes-to-waste/261498/

http://www.urbancultivator.net/facts/

https://www.livestrong.com/slideshow/1011186-9-hidden-food-industry-doesnt-want/

https://pos.toasttab.com/blog/10-fast-food-industry-statistics

https://www.statista.com/topics/1957/eating-out-behavior-in-the-us/

Why compliance trainings are critical for organizations?

Many organizations offer compliance trainings only superficially, as if it were an appendage to the organization’s training program.

Trainings are a necessary ingredient for excellence in organizations. On-the-job training is almost a must for most employees at various levels in organizations. Trainings are necessary for a variety of reasons. Many employees who are just out of college may sometimes feel the need to get trained to help them understand the organization and the job better because the actual work the organization does may not be part of the curriculum they may have studied when at college or university.

Others may get trained about policies and culture. Even this training is important as it helps the employees understand the company’s policies and its thinking. In addition to all these, a very crucial kind of training is compliance trainings. Compliance trainings should perhaps rank as the most important of all trainings for organizations. Yet, unfortunately, it is not accorded the seriousness it deserves. Many organizations offer compliance trainings only superficially, as if it were an appendage to the organization’s training program.

What is compliance training?

To understand why compliance trainings are critical for organizations, let us start by understanding compliance trainings. Compliance trainings are trainings offered to employees at all levels to help the organization stay compliant with the regulations pertaining to its industry. Many industries are regulated by the regulatory agencies such as the FDA, the EMA, RAPS, Pharmaceuticals and Medical Devices Agency (PMDA), Health Canada and many others from around the world.

Compliance trainings are imperative for organizations that are regulated by these bodies. These agencies set out the regulations pertaining to a wide range of aspects about these businesses. Complying with these regulations is the only way to:

– Ensure the quality and safety of the products or services offered by the business

– Avoid being penalized by the regulatory agencies for noncompliance

– Earn a reputation by which they will be respected by their stakeholders.

Compliance training is the only real means to help organization accomplish all these goals. It is only through compliance trainings that organizations are able to meet the regulatory demands. Meeting regulatory requirements, as just mentioned, is the surest means to achieving business and governance goals.

How to implement & how they implemented in present condition https://goo.gl/BjmeEu

What Makes FDA Guidelines So Addictive That You Never Want to Miss?

When this is the rationale for which the FDA passes its guidelines, the imperative to meet these guidelines becomes clear.

What makes FDA guidelines so addictive that you never want to miss them? Well, FDA guidelines are something like the reminders for your car servicing. What happens when you buy a car? You get reminders from your dealer asking you to service it on time. The reason: your car is meant to be in fine shape when you drive it on the roads in real life conditions. What happens if you miss the service deadline? Nothing, except that you could be responsible for an accident which causes severe consequences.

Now, in this scenario, what if you had an idea of how much damage your car could cause in which type of accident? Would you still want to miss the servicing and checkup date? This is the summary of the principle of what makes FDA guidelines so addictive that you never want to miss out on them! Simple: just like how an inadequately serviced car or any other vehicle can lead to accidents and carry grave consequences for either the driver or the accident victim or both; having products in the market that don’t adhere to FDA guidelines has its costs.

Understand the reasons for which guidelines are issued

It is in everyone’s interest to ensure that products produced by companies in the regulated industries meet FDA guidelines. Their task will become a lot less tedious when they understand the importance of these FDA guidelines. After all, for whose benefit are these guidelines made? Is it for the FDA’s? No. It is for the benefit of the consumers, the organizations marketing these products, and for the general health of the public. When this is the rationale for which the FDA passes its guidelines, the imperative to meet these guidelines becomes clear.

To take the case of the example given here further, there is another very strong reason for which meeting FDA guidelines is addictive to the extent that you never want to miss them: stringent enforcement actions that follow from non-implementation. The FDA has prescribed strict penalties for different kinds of non-implementation of its guidelines. Its enforcement actions are carried out in the following four broad categories:

Warning Letters: The first and mildest of enforcement actions; a Warning Letter notes the violations the company may have committed and advises them on what action has to be taken to correct them.

Seizure: This action is about confiscating an adulterated or misbranded product and ensuring that such products do not enter the market or removing them if they already have.

FDA guidelines so addictive that you would never want to miss them!
https://goo.gl/gzUxeX

Simple but [Important Things] to Remember About FDA Trainings

FDA implementation is not something that an organization can take chances with. Why? The consequences of non-implementation are too grave to do this.

When you work in an industry that is regulated by the FDA, one thing that is as certain as day and night is the fact of FDA regulation. Of course, this is as obvious as saying that solar power is derived from the sun and is as silly as asking if the FDA regulates FDA-regulated industries! The point being made is that regulation is the essence of the FDA’s existence. The FDA has been created to regulate certain industries with the intention of ensuring safety and reliability of the products.

This makes FDA trainings an absolute imperative for organizations that are regulated by the FDA. They are so important in meeting FDA regulatory requirements that FDA trainings are not just desirable, but indispensable in helping organizations do this. the question is, can’t organizations implement FDA guidelines on their own without the help of trainings?

Well, fact is, they can, but what makes FDA trainings a must is that their implementation in all the fullest details and in the exact prescribed manner is the surest means to avoid confusion or misconceptions or misgivings about implementation of the prescribed FDA guidelines. FDA implementation is not something that an organization can take chances with. Why? The consequences of non-implementation are too grave to do this. Organizations can face the backlash from the general public if their product harms its consumer. Additionally, they can face terrible consequences of a very strong nature from the FDA.

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So, now that the need for FDA trainings is beyond doubt, what are the factors that FDA-regulated companies need to keep in mind when undergoing FDA trainings? Let us look at some of the simple but important things to remember about FDA trainings:

First and foremost, the FDA itself prescribes training for the relevant staff in their area of work. Like the ISO, the FDA also makes training for personnel necessary for those in manufacturing necessary to attain proficiency in their work and meet regulatory guidelines.

However, the FDA does not get down to the specifics of the training, i.e., what trainings are to be undertaken by which kind of staff and who should impart this training and how to do it. It leaves this to the discretion of the companies. This being the case, it is necessary for these regulated companies to know simple but important things to remember about FDA trainings.

Important things about FDA Trainings https://goo.gl/9UYYpc

Which can leave the work of meeting regulatory requirements to FDA Services

Many FDA consulting services companies offer advice on drugs, dietary supplements, clinical trials, food and tobacco, and medical devices.

FDA consulting services are those services that are offered by independent, mostly private companies in helping to meet FDA requirements. FDA consulting services are offered to organizations that have to meet FDA regulatory requirements. Many companies across the US and many other parts of the world specialize in offering FDA consulting services and these are often the main business for these organizations.

Why do companies offer FDA consulting service?

FDA consulting services are offered because most organizations find the maze of FDA regulation too complex, confusing and time consuming. FDA consulting services are an easy way out for these organizations, which can leave the work of meeting regulatory requirements to FDA consulting services and concentrate on their core areas of business.

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What do FDA consulting services do?

FDA consulting services usually carry out all tasks associated with and required for meeting FDA regulatory requirements. While they may not be involved in the business per se, they help in the documentation part, because this is where their help is required. FDA consulting services help companies in achieving and maintaining all aspects of FDA compliance. This is done for a fee, of course, and is considered legal outsourcing.

In what areas are FDA consulting services offered?

Most FDA consulting services companies offer consulting relating to everything about FDA regulation, although some FDA consulting services companies do so only in select, specialized areas. The services offered by FDA consulting usually include the following:

  • Helping before,during and after an FDA inspection
  • FDA 510(k) Submissions
  • Audits and inspections
  • Audits and gap analysis
  • Writing Standard Operating Procedures (SOPS) forms and reports
  • Form 483 and responses
  • Responses to Warning Letters
  • Investigational Device Exemption (IDE) submissions
  • Serious Adverse Event Reporting
  • Medical Device Reporting

Many FDA consulting services companies offer advice on drugs, dietary supplements, clinical trials, food and tobacco, and medical devices. They also carry out complex tasks like QSR reviews, GCP, GMP, GLP audits, New Drug Application (NDA), Biologic License Application (BLA), Abbreviated New Drug Application (ANDA) and Premarket Approval (PMA), as well as remediation for companies that have to respond at short notice to compliance issues raised by the FDA.

What happens when an FDA Form 483 is issued?

An issued FDA Form 483 contains all of the inspector’s observations and judgments made during the inspection.

One of the chief aims of the FDA is to ensure the protection of public health and making sure that select types of organizations comply with the provisions of the Food, Drug and Cosmetic Act. It enforces these aims by conducting periodic inspections of the facilities and types of organizations that come under its purview. The FDA is empowered by the terms of the Federal Food, Drug, and Cosmetic Act, Sec. 704 to carry out these inspections to meet its stated intent. These organizations include:

  • Clinical trial sponsors
  • Clinical trial investigators
  • Institutional Review Boards (IRB)
  • Facilities that are involved in the business of manufacturing, processing or packing of FDA-regulated products

When the FDA finds that the organization is not meeting the set requirements; it issues either a Form 483 or a Warning Letter to the organization at the conclusion of the investigation. The first of these steps is the Form FDA 483. It is used to list the observations made from the inspection, in which it documents and communicates its concerns that it observes during its inspections. The FDA in its website says that the FDA Form 483 is issued to the management of the company “when an investigator(s) has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts”.

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How does the FDA observe its findings?

The FDA ensures that there is no subjectivity in the matter of its observations, which is the prelude to issuing the company an FDA Form 483. There are no grey areas or any kind of arbitrariness on the part of the FDA investigators when they carry out their observations.

The FDA investigators are thoroughly trained to ensure that their observations are noted on the FDA Form 483 in a clear and specific format before it is issued. These are based on the thorough and demonstrable observations that the investigator makes. These observations should reflect that the “food, drug, device or cosmetic has been adulterated or is being prepared, packed, or held under conditions whereby it may become adulterated or rendered injurious to health.”

An issued FDA Form 483 contains all of the inspector’s observations and judgments made during the inspection. It will clearly specify the areas in which the organization fell short of regulatory requirements and expectations. When an FDA Form 483 is issued, it calls for a response within 15 working days of the issue. Although a written response is not a mandatory requirement; it constitutes good practice and is preferred. The response has to detail the reasons for the shortfalls and ways by which the organization will remedy them.

If the organization does not file a satisfactory response to the FDA Form 483 violations within the specified time period, it is issued a Warning Letter. The Warning Letter is the next action the FDA takes to elicit a response. The organization has to file a response to it within 15 working days. If it wants more time, it will have to ask for it in writing. If the FDA Form 483 and Warning Letter fail to evoke a proper and satisfactory response within this period, the FDA may proceed to take the appropriate legal action against the organization. Based on the nature and gravity of the deviations, these legal actions could include suspension or cancellation of the manufacturing license, withholding of the product approval, or even shutting down the business.