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

Want to Have a More Appealing FDA CFR 21 Part 11? Read This!

The most important ones among these are Computer System Validation, data security, and data backup.

Title 21 CFR Part 11 is one of the sections of the FDA that inspires both awe and respect. Commonly known as 21 CFR Part 11, this section deals with and establishes the criteria for the FDA’s requirements relating to electronic records and electronic signatures (ER/ES). All the requirements which the FDA expects for electronic records and electronic signatures to be considered trustworthy, reliable and equivalent to paper records are set out in this section.

For the FDA to consider electronic records, electronic signatures and handwritten signatures to be on par with handwritten ones and proven for their safety, trustworthiness and authenticity; companies in the designated industries governed by FDA regulations have to meet conditions set out in 21 CFR Part 11. It is only when these conditions are met that the FDA considers these records to have the same effect or worthiness of an actual paper record.

As paper made way for electronic versions with the advent of technology; FDA 21 CFR Part 11 regulations evolved with the intention of helping to overcome some of the obvious drawbacks of paper records:

  • Their potential to be manipulated or forged
  • Their destructibility
  • Lack of authenticity.

FDA 21 CFR Part 11 regulations came into being to give electronic signatures the same effect as those of paper ones. These regulations seek to make the electronic signatures as authentic as the paper records they replace through a set of well-defined scientific means. FDA 21 CFR Part 11 is designed to give regulatory authorities the confidence and scientific validation for this authenticity.

The core areas of 21 CFR Part 11 implementation

21 CFR Part 11 regulations compliance covers three core areas:

Standard Operating Procedures

There are nearly 12 Standard Operating Procedures prescribed in the 21 CFR Part 11 regulations for addressing the company’s IT infrastructure. The most important ones among these are Computer System Validation, data security, and data backup.

System features

21 CFR Part 11 regulations require close to 50 industry-related features that organizations need to implement into their computer systems to be compliant with the regulations.

Computer System Validation

The core of 21 CFR Part 11 regulations is Computer System Validation. The purpose of implementing CSV is to ensure that the FDA has documented evidence that each computer system in the organization carries out exactly what it is expected to and helps users detect and identify errors.

How to make your 21 CFR Part 11 effective

Since implementation of 21 CFR Part 11 is mandatory in the industries for which it is stipulated; it is necessary to those who work in these industries to get a proper and thorough idea of how to properly implement the provisions of this regulation.

Adapt a risk-based approach. This is the foundation to 21 CFR Part 11 implementation 

The basis to effective implementation of 21 CFR Part 11 is to take a risk-based approach to implementation. A risk-based approach should take all the possibilities of risk into the area of electronic signatures and work on ways of countering them. Understanding the risks is the foundation to implementing 21 CFR Part 11 effectively, as it helps to identify areas from which risk could arise to the electronic signatures.

The risk-based approach is not only a very solid means to ensuring the effectiveness of 21 CFR Part 11 regulations; it also prevents the organization from being cited by the FDA, since this is the method the FDA itself suggests and welcomes. It is also extremely useful in making the organization’s computer systems more effective and inexpensive over time.

Train your staff

The key to effective and proper 21 CFR Part 11 implementation is for the organization to let its employees know the importance of this regulation. It is only when employees, as stakeholders in the organization’s growth, are enlightened about the importance of critical regulations such as 21 CFR Part 11 that they understand why they need to implement, what benefit they get out of implementing it, and what they stand to accrue in terms of penalties for lack of implementation that they take a keen interest in its implementation.

Again, training too, is a core FDA requirement. The FDA has laid out clear-cut guidelines of how to train employees for 21 CFR Part 11 implementation and the ways of documenting the training. Organizations that comply with these requirements are less likely to invite FDA actions.

This Article Will Make Your Environmental Compliance Amazing: Read or Miss Out!

Both EPA and OSHA have tons of information about every aspect of environmental compliance. They are handy and easy to understand.

Environmental compliance is a critical requirement for workplaces in many parts of the world. In the US, this aspect of compliance is undertaken by the Environmental Protection Agency (EPA) in conjunction with the Occupational Safety and Health Administration (OSHA). These agencies coordinate with each other to ensure that environmental hazards are kept within specified limits so that they don’t affect the workforce or cause damage to the environment beyond prescribed norms or levels.

An example of the way by which these two agencies coordinate is the one that relates to the control of accidental release of chemicals from designated workplaces that may have an adverse impact on employees, the environment or the general public. While OSHA is given the responsibility of ensuring that chemical releases do not affect workers in the workplace under Sec. 304; Sec. 112 (R) of the EPA’s Clean Air Act describes how to protect the general public from the effects of such hazards.

In areas such as chemical accident prevention, the EPA and OSHA work closely in a number of designated areas, which include:

  • Helping companies that come under their regulatory guidelines to ensure compliance
  • Guiding and interpreting the regulations
  • Coordinating in strategies and actions relating to enforcement and compliance
  • Putting in place and implementing mechanisms for sharing information.

The fact that two federal agencies work in tandem to ensure environmental compliance makes this a serious issue that companies can ignore only at their own peril. The understanding of facts such as this goes a long way in ensuring environmental compliance because it drives home the criticality of ensuring environmental compliance.

Simple, yet effective tips for ensuring environmental compliance

This article will make your environmental compliance amazing: it offers simple, down-to-earth tips on how to ensure environmental compliance rather than drilling down complex and incomprehensible insights. These are some of the steps you could take to ensure environmental compliance:

Be in touch with the government agencies

This is the most obvious, yet the most effective way of ensuring environmental compliance. It is the governmental agencies that are responsible for ensuring compliance. So, who could be a better guide to help you with yours? Directly interacting with agencies such as EPA and OSHA will help you take the proper steps right in consultation with them. Also, make ample and maximum use of the resources that are available all over the Net. Both EPA and OSHA have tons of information about every aspect of environmental compliance. They are handy and easy to understand.

Take expert help

Experts are what they are: very knowledgeable professionals in their field. Taking the help of an environmental compliance expert will help you stay clear of the provisions relating to environmental compliance. Selecting the appropriate one in this connected world should never be an issue.

Implement compliance software

Many software applications that not only guide you in compliance but also carry out most of the requirements are available in the market. This type of software application is very helpful in taking the pain and the guesswork out of environmental compliance implementation. Agreed, the cost of buying, installing and running these software applications can be expensive. Yet, this cost neutralizes over the long run. More importantly, this cost is very small in relation to the cost of noncompliance.

Train your employees

No understanding of the regulations or implementation of any other tip is of any value unless the employees become an active part and stakeholders in ensuring compliance with the environmental regulations. Employees are the central players in environmental compliance. It is primarily for them that all the regulations are made. These are the core stakeholders in ensuring environmental compliance. The key is to make understand the benefits they get by implementing and complying with the environmental guidelines. This is when they can become active players in the entire endeavor.

Too Busy? Try These Tips to (Streamline) Your Supply Chain Finance

Finance is the lifeblood of any business. Its role in a business with various interconnected loops such as supply chain is all the more prominent.

Too busy worrying? Trying these tips to streamline your supply chain finance could go a long way in helping you improve your bottom line. One of the very critical, yet often overlooked components of the supply chain is finance. Finance is the lifeblood of any business. Its role in a business with various interconnected loops such as supply chain is all the more prominent.

Supply chain rests on free movement of goods. It is built like a relay race in which goods are transported from one point to another. The essence of running a well-coordinated supply chain machinery is keeping the different connecting points well-oiled. One of the best mediums that facilitate this is finance. Why? Quite naturally, because when the different points of the supply chain are properly financed, the goods don’t get held up at any point. This is a point that a recent Ernst & Young study entitled, “Partnering for Performance — the CFO and the Supply Chain” brings about strikingly. It notes that there is an inseparable bond between well financed supply chains and higher earnings for organizations.

As important as the technologies

This points to the paramountcy of finance to the supply chain. The supply chain may have used the best technologies to put the most efficient tracking systems in place. It may have every bit of information to keep the supply chain up and running. But finance is the real essence of the operation. If for reasons related to finance there is some disruption in a part the chain, it affects the whole system adversely, carrying with it the potential to bring the entire chain to a halt.

Too busy? Try these tips to streamline your supply chain finance

By its very nature, supply chain is prone to a lot of volatility. It runs on coordination of many factors and between several players in the link. One loose link can destabilize the entire system. Let us say a shipment reaches a link in the supply chain. When there is a change in the requirement, requiring the content in the supply to be changed, it leads to delays in delivery. Till that time, the supplier has to bear the cost of the transportation, which leads to severe denting of margins, since the costs will go up.

Been too busy? You could try these tips to streamline your supply chain finance: The solution to this problem is financing the entire supply chain through means that are more or less favorable to everyone concerned. If all the parts of the supply chain are well financed, they will be able to absorb the shocks of such supply chain problems without having to sacrifice their business. This calls for financing at all levels of the supply chain. This is a very sound protection for all the uncertainties of goods and payments.

How is this to be done? That brings us to the next vital step in streamlining the supply chain finance: the use of technologies. Technologies such as supply chain management systems help companies to have complete visibility and control of the entire supply chain. This will help them understand just where the goods are stuck and the exact shortfall in finance that brought this about. When these systems are built on the cloud, they can become more versatile and cost-effective. Companies can also deploy the cloud for Business Analytics, which will throw up exact figures and insights pertaining to these aspects. A historical overview will help them which part of the supply chain to finance and how quickly.

Use of blockchain can ease the supply chain finance

Further, blockchain can go a long way in ensuring the transparency of the transaction at every stage. Blockchain, as we all know, is a highly decentralized online ledger system which will allow every transaction to be tracked and also made immutable with the record of the details of the transaction at every phase. Using this will help supply chain finance to be in perfect order and rid companies of all the confusion accompanying some kinds of transactions. They can always go back to the transaction to check its history and veracity.

https://www.infor.com/content/whitepapers/mastering-supply-chain-finance.pdf/?noRedirect=1

http://www.apics.org/apics-for-individuals/apics-magazine-home/magazine-detail-page/2017/07/13/the-supply-chain–finance-connection

Don’t Neglect to read in this busy life https://goo.gl/oKBs4t

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.

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