Quality Risk Management in the FDA-Regulated Industry

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Quality risk management in the FDA-regulated industry is a vital area of regulation for the FDA. Risks to quality may arise from many sources. The FDA has entrusted itself with the responsibility of making sure that the quality of the products it regulates is maintained through a due process.

Quality risk management in the FDA-regulated industry is an extremely broad area that straddles Quality in almost all areas that the FDA regulates. The FDA has regulations for particular areas of Quality, such as pharmaceuticals, medical devices, drugs, life sciences and so on. Quality risk management in the FDA-regulated industry is aimed at utilizing core principles in many areas of health and public safety.

Benefits should outweigh the risksThe rationale for Quality risk management in the FDA-regulated industry is that the benefits a product brings for its users, namely patients, should be greater than the risk it brings in its wake. Risk, as we all know, is something like a side effect or a shadow, which accompanies the product just whenever and wherever it is used, and the products itself is unthinkable without the risk. Risk managers and regulators alike acknowledge the fact that risk is not only avoidable; it is not something that can be eliminated fully.

quality-risk-management-in-fda-regulated-industrySo, how feasible is Quality risk management in the FDA-regulated industry when it is a given that risk is inherent in any product or activity? As mentioned above; the FDA (or for that matter, any other regulatory agency) proceeds on the belief that risks can only be mitigated. This certitude is the cornerstone of formulation of policy concerning Quality risk management in the FDA-regulated industry. So, the FDA formulates best practices and regulatory requirements for containing risk.

Quality risk management as laid out by the FDAThe FDA formulates risk management strategies and best practices that help manufacturers understand the ways of risk mitigation and hazard control, so that the maximum possible safeguards are put in place to ensure risk mitigation. The FDA goads manufacturers to imbibe risk management into their core, suggesting that they make it a part of their culture.

quality-risk-management-in-fda-regulated-industryThe proper use of the principles of Quality risk management in the FDA-regulated industry is aimed at fostering compliance with regulatory requirements. Quality risk management in the FDA-regulated industry is tied to a few important principles such as Good Manufacturing Practices and Good Laboratory Practices, among many others.

The Q9 Quality risk management guidelineThe primary guidance set out by the FDA for compliance that ensures Quality risk management in the FDA-regulated industry is the Q9 quality risk management guideline. Among the fundamentals required in the quality risk management process of this guideline are:

  • Assumption of responsibilities for implementing and ensuring Quality risk management in the FDA-regulated industry by people in an organization who are entrusted with the task of decision making regarding quality
  • Initiation of a process for quality risk management
Risk assessment is a major exercise at which the following need to be taken into consideration:

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Quality risk managementRisk assessment is also built on a triad of principles as part of Quality risk management in the FDA-regulated industry:

quality-risk-management-in-fda-regulated-industryFurther, the next steps in Quality risk management in the FDA-regulated industry are:

  • Risk control, consisting of issues such as:
    • Ways by which to reduce it
    • Striking a balance between risks, benefits and resources
    • Identification of possible new risks in the process
  • Reduction of risk
  • Acceptance of risk
  • Communicating of the risk in the proper manner and to the right person(s)
  • Review of the risk.

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Risk Management and Compliance in the Healthcare Industry

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Risk management and compliance in the healthcare industry requires a high degree of foresight, observation and knowledge of the regulatory rules and principles. Apart from being aware of the regulations, risk management and compliance in the healthcare industry is a lot about being smart, inventive and observative about the day-to-day aspects of the workings of the industry, as this highly operationalized activity is changing at a rapid pace.

Risk managers in charge of risk management and compliance in the healthcare industry need to equip the Board of Directors of the healthcare settings in which they work with much more than just the regulations that need to be put in place. They also need to impart insights into how this is to be done while keeping the costs low and at the same time, improving business.

These are the most important factors that make risk management and compliance in the healthcare industry extremely important:

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Regulatory pressure is too much to bear

 

In the current scenario of highly reinvigorated regulatory oversight in the healthcare industry, there is heavy pressure on risk managers to implement risk management and compliance in the healthcare industry in an optimal manner. The fervor of regulatory requirements and level of supervision from the regulatory bodies have gone up so drastically of late that in a recent survey, PriceWaterhouseCooper found out that half the people on the corporate board governance in hospitals said that they regard risk management as their greatest priority for the next few years.

This trend is triggered by a host of factors, all of which could contribute to making risk management and compliance in the healthcare industry all the more critical in the years ahead. Some of the factors that have accelerated this sense of urgency and criticality are:

Burgeoning cost of healthcare: 

risk-management-and-compliance-in-the-healthcare-industryAs the US healthcare industry grows into a multi-trillion dollar industry; there is a need for ensuring risk management and compliance in the healthcare industry.

Rapid increase in many diseases: Many diseases in the US are mostly a result of undisciplined and profligate lifestyles. This has placed a heavy burden on the healthcare sector to both implement preventive measures and improve standards in healthcare administration.

Technological improvements: History has shown that every improvement in technology has brought about more and more illnesses and disease, as technology makes people more sedentary. This has increased the pressure of risk management and compliance in the healthcare industry, as they are under higher pressure to implement strategies aimed at containing these.

Need to reinvent to stay ahead of the curve

 

All these factors are pushing corporate boards in healthcare to take a relook at the way risk management and compliance in the healthcare industry has been functioning. They have realized the need to implement these with a fresher and more urgent, yet intuitive approach. They need not just the judiciousness needed for grasping the present state of affairs in the industry; they need to also have sufficient foresight in anticipating the kind of change the industry is likely to undergo in the next few years.

risk-management-and-compliance-in-the-healthcare-industryThe proper understanding and implementation of risk management and compliance in the healthcare industry sits at the core of this need for hospitals to stay abreast and ahead of the competition. Relying on traditional models of risk management and compliance in the healthcare industry is likely to take them only that far. The risk managers need to have the ability to develop enterprise-wide risk management strategies that withstand the onslaught of rapid changes and absorb them into the system.

 

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What are the potential areas of risk management?

 

What are the potential areas of risk management.jpgThe most critical aspect of risk management is the identification of potential areas of risk management. This helps the organization to stay focused on the areas in which it could possibly face risks, rather than taking an aimless view and shooting about in the dark.

In a very broad sense, the potential areas of risk management include all areas of a business, because simply no area of the business is exempt from a risk. Talk about finance, and it comes with a risk. What about manufacturing? And what about operations or marketing? How about human resources? In this very expansive sense, every area or activity of the business is among the potential areas of risk management.

Potential areas of risk management could lie simply anywhere

potential-areas-of-risk-managementOn top of these potential areas of risk management that each part of the business is prone to; there are also the other industry-related risks that inhere into any business. The risks of running, say, a firecracker business, are much higher than running a grocery store. So, potential areas of risk management should ideally include a very broad discussion on every aspect of risk management.

However, when one takes an overview of the potential areas of risk management instead of trying to break down the elements of each function in which there are potential areas of risk management; one can classify these among them:

Generic risks: As we have been discussing, any business, absolutely any business, comes with some degree of risk. And, each business comes with its own generic risk, such as falling short of funding at crunch times, core people leaving the organization at important times, logistics failures at critical times, and so on.

potential-areas-of-risk-managementProduct specific risks: As the title suggests, this kind of risk is specific to the product that the business deals with. Some products come with their unique risks, and hence, this kind of risk counts among the potential areas of risk management.

People-specific risks: These can happen in a business in which much depends on a few important people. The inefficiency or departure of such people could be among the potential areas of risk management for businesses or projects that are dependent on people.

potential-areas-of-risk-managementFinancial risks: Obviously among the top potential areas of risk management; financial risks come into play when the organization is not able to meet its bottom lines due to a variety of factors. Not getting funds on time, not getting payments from customers on time, not being able to service debts are some of the factors of financial risks.

Technology risks: Technology is a high area of risk, because it keeps changing at a breakneck speed. If organizations don’t keep up with the pace, technology risks could count among potential areas of risk management.

potential-areas-of-risk-managementMarket risks: Market risks are yet another of the potential areas of risk management because most businesses are run on the assumption or speculation that a market is going to grow at a certain rate or pace. If the estimate of this market goes wrong, it affects the business negatively.

Customer risks: The ultimate decider of the business is the customer. If a customer gets irate at a bad product or service and issues bad press, it could become one of the biggest of the potential areas of risk management.

potential-areas-of-risk-managementReal estate risks: For some businesses, especially retail, the location of the business is a major factor. In many instances, the choice of location could often decide the fate of the business. Imagine setting up a high end retail store in the vicinity of a slum. Does that make sense? Yet, even if a business chooses the right location, it could sometimes be forced to relocate due to factors such as legal issues of the property, making this among the potential areas of risk management.

Finally, what needs to be said is that the list above is by no means a comprehensive one. The potential areas of risk management, as we have discussed at the beginning, are simply too many and too fluid and subjective. They could vary from market to market, product to product and business to business. A business that is perceptive about the market has to make the right assessment of the potential areas of risk management before it starts one. It should also be ready to face the potential areas of risk management if it is up against any factor that lies beyond its reach or forecast.

 

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Understanding the importance and benefits of auditing Quality Management Systems

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Auditing Quality Management Systems is a core requirement for ensuring that Quality Management Systems – defined as “…a set of policies, processes and procedures required for planning and execution” in the core business area of an organization, meaning those that impact the ability of the organization to meet customer requirements – are updated and kept in compliance with regulatory requirements. The ISO 9001 set of standards is a step towards helping organizations achieve this end.

The ISO 9001 series, aimed at facilitating and ensuring that organizations of various kinds audit their Quality Management Systems in tune with regulatory requirements set out in this standard; was first implemented in the 1980’s. Today, across the globe, over a million organizations have been certified for complying with its requirements. The ISO 9001 is a tool for auditing Quality Management Systems across all kinds of organizations: big, small or medium to one stop providers to multinational organizations that operate in various geographies.

Why is auditing of Quality Management important?

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ISO standards have been arrived at after years of practice, observation and trial and error endeavors. These standards have evolved over continuous implementation of many best practices that are suited to particular organizations based on the size of their operations and the nature of their business.

An organization that has been in the practice of auditing Quality Management Systems is said to be implementing a better way of dealing with risk management. It is also considered an organization that enjoys enhanced stakeholder and customer confidence, as well as an improved, efficient and effective management and operational systems.

More than anything else, auditing Quality Management Systems are the surest means to ensuring that products and services from an organization meet certain prescribed processes and standards. An auditing Quality Management System officially certifies that the organization task a risk-based, process oriented, streamlined approach to ensure the safety, reliability and consistency of its products and services. A company that puts auditing Quality Management Systems in place is said to be more conscious of meeting customer expectations and makes continuous efforts and improvements into its products and services and complies with the law.

Certification is proof that the organization is auditing its Quality Management Systems

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Certification is like the proof of the pudding in Quality Management Systems audits. A company may claim to be implementing quality standards, but how does the world come to know about it? It is only through auditing Quality Management Systems certification that this happens. For a company to earn auditing Quality Management Systems certification; it has to be audited by the ISO. Upon careful scrutiny of its practices, the ISO awards the organization the 9001 Quality Management Certification.

What are the benefits of auditing Quality Management Systems certification?Certification from the world’s leading Quality Management Systems auditing certifying body gives such an audited and certified company a host of credentials and benefits. These are some of them:

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Good Manufacturing Practices are essential for ensuring quality

Good Manufacturing Practices (GMPs) constitute one of the core components that go into the manufacture and distribution of foods, drugs and other pharmaceutical products. Good Manufacturing Practices are prescribed by regulatory agencies from around the world, the FDA and the EMA being among them.

The guidelines set out by these regulatory agencies are aimed at bringing about standardization in the process of manufacture of these products and to ensure their quality. The utmost diligence of organizations that manufacture these products is called for.

goodManufacturingPracticesThe FDA attaches the highest importance to quality, since drugs and pharmaceuticals are consumed by millions of Americans for a variety of diseases and conditions. Keeping this in mind, the FDA has formulated guidelines with which manufacturing maintains set quality standards across a range of products ranging from foods to pharmaceuticals. The whole set of guidelines for manufacturing products in a variety of industries and activities is clubbed under the collective term, “Good Manufacturing Practices (GMP)”. The FDA attaches the highest importance to quality, since drugs and pharmaceuticals are consumed by millions of Americans for a variety of diseases and conditions. Keeping this in mind, the FDA has formulated guidelines with which manufacturing maintains set quality standards across a range of products ranging from foods to pharmaceuticals. The whole set of guidelines for manufacturing products in a variety of industries and activities is clubbed under the collective term, “Good Manufacturing Practices (GMP)”.

Since these best practices keep changing from time to time and the latest developments overshadow the existent ones; the FDA expects manufacturers to keep abreast of the latest regulations it passes, called cGMP, meaning “current” Good Manufacturing Practice.

No single set of standardsgoodManufacturingPracticesGMPs and cGMPs are not a single, rigid and monolithic set of standards or rules that everyone is expected to implement in their manufacturing systems. The regulatory agencies prescribe a broad set of general principles, from which a manufacturer from particular industries have to implement at a minimum level of quality requirements, the ones appropriate to it. Further, these guidelines offer options on the ways by which those regulations that are relevant to it can be accomplished. The organization needs to determine the one that suits it best for implementing that system.

Purpose of Good Manufacturing PracticesgoodManufacturingPracticesWhy the regulatory agencies take this task upon themselves is because the consumer is not in a position to identify a spurious product or one that has not been through all these scientifically designated processes. The fundamental purpose for which the regulatory agencies require adherence to the CGMP regulations is that compliance to these guidelines is a means to assuring the following:

goodManufacturingPracticesIn order to achieve this, drug manufacturers have to take all the steps needed to control the manufacturing operations. This includes establishing strong Quality Management Systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories.

The FDA believes that putting all these steps and processes in place through this formal system of controls by a pharmaceutical company is a means to prevent mix-ups, contamination failures, deviations and errors. In addition to ensuring that drug products that go through these processes meet their quality standards; the cGMPs help to put in place systems with which proper design, monitoring, and control of manufacturing processes and facilities are assured.

Highlights of GMPs/cGMPsThe nature and role of current Good Manufacturing Practices can be summarized into the following:

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The GMP regulatory requirements in the EU

The EMA, being the regulatory agency for the EU; oversees the implementation of cGMP guidelines. The EMA’s guidelines apply to all the Member States of the European Union. The purpose for which these guidelines are set out by the EU is more or less the same as that for which other agencies such as the FDA lay out these rules. The essential reason for which this is done is to ensure that the pharmaceutical or any other regulated products:

goodManufacturingPracticesThe EU’s directives on GMP are listed out in its important legal frameworks and guidelines. These include:

  • Regulation No. 1252/2014 and Directive 2003/94/EC, which are for active substances and medicines for human use
  • Directive 91/412/EEC, which relates to medicines for veterinary use
  • Directive 2001/83/EC and Directive 2001/82/EC, which prescribe related provisions.

 

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The ISO 13485: 2016

The ISO 134855

The ISO 13485, which is the ISO’s global medical device standard; was upgraded significantly in 2016. This upgrade was carried out primarily to help the standard keep up with the changes that have taken place in the industry in about the decade and a half since the previous standard was brought into effect in 2003. Changes have taken place in a number of key areas of the medical device field, but the most important changes relate to the changes in technology and in relation to the increased importance of risk management at almost all levels in the medical device industry.

The earlier version was based on the ISO 9001:2000 standard, while the new upgrade is based on a later standard, the ISO 9001: 2008. Changes have been carried out into almost all the sections of the new standard, with the most important areas that have been changed including flexibility, the requirements from medical device companies to adhere to regulatory requirements, the inclusion of the risk based approach into the organization’s QMS, medical device filing and documentation, verification and validation, design and development, training, supplier monitoring and so on.

QMS is an important area of change

The ISO 134851

The QMS is the most prominent area in which the new document differs from that of the earlier version. Although the new version is considerably more closely aligned to the FDA’s Quality System Regulations (QSR); there still exist major differences. Not getting a proper grasp of these differences has the potential for creating problems in implementation.

Medical device companies also need to consider the Medical Device Single Audit Program (MDSAP), the mechanism through which the regulatory systems in a few jurisdictions will continue to rely on ISO 13485:2016. In relation to this mechanism, the fundamental difference between the US and the EU is this: the US will participate in MDSAP, but doesn’t expect to change its regulations, while the EU is not going to participate. It has published its own version, EN ISO 13485:2016, and will continue with the existing Notified Body system. however, the EU will promulgate in its own set of new regulations that will replace the directives. These will lead to new regulations, which will be new versions of EN ISO 13485:2016 and EN ISO 14971:2012.

It is crucial for medical device companies to keep track of the changes introduced in ISO 13485:2016, as this is the new standard that they have to comply with. While it is not legally binding to do this; they gain in a number of ways in being compliant with these changes.

Proper and full learning of the ISO 13485:2016

The ISO 134852

Being compliant with the new version requires a clear understanding of the new regulation, the ways in which it has to be implemented, the areas of work that need to be changed, and so on. A seminar being organized by GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will explain all these.

At this seminar, the Director is Dan O’Leary, who is the President of Ombu Enterprises, LLC. Dan, who brings more than 30 years’ experience in Quality, Operations and Program Management in regulated industries including aviation, defense, medical devices, and clinical labs, will offer a complete understanding of how the new regulation needs to be implemented.

Please log on to The ISO 13485: 2016 to enroll for this seminar and get the right perspective of how to implement ISO 13485:2016. This seminar has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Implementation needs to be done quickly

The ISO 13485

The final version of the new ISO 13485:2016 standard is now available for companies to start implementing. The areas into which changes have to be carried out are quite expansive and huge in number. For many companies, the timeframe for implementation is quite short, depending on the expiry date of their current certificate. Dan will help participants overcome this handicap, and will offer practical implementation advice and suggestions to participants.

He will also use exercises and examples to help participants understand the ways of implementing according to the new guidelines and also analyze the implications of the newly revised regulation, in particular, regulatory systems including MDASP and its nonconformity grading system. This seminar will have the following agenda:

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An inclusive Ukrainian education

An inclusive Ukrainian education

Education is one of the few areas nowadays that is still considered a purely sovereign matter, an issue over which national governments – and, in many countries, even local authorities – should have control. But, in today’s world, it seems that no issue is immune to political manipulation. That is the case with Ukraine’s new framework law on education, which has become the target of harsh opposition not so much from within the country, but rather from some neighbouring countries.
The law, adopted last month by Ukraine’s parliament, reflected a long and inclusive policymaking process. Among its provisions is Article 7, which specifies that students in schools and universities should study in the national language. Article 7 seems to be in accord with European norms. Perhaps more important, it will benefit all Ukrainian citizens, including minority-language speakers, who will be better equipped to integrate fully into Ukrainian society.
Under the previous education system, some students would receive their entire 11 years of schooling (to be raised to 12 under the new law) in a minority language, mostly Russian, but sometimes Hungarian and Romanian. About 400,000 students are currently on such a track, which has usually ended with students graduating high school lacking even a working knowledge of Ukrainian – the language in which the country conducts its business.
In fact, just this year, more than half of all graduates of Hungarian-language schools failed tests of Ukrainian. Unable to attend a Ukrainian university, these students have little choice but to find local work in Hungarian that requires only a secondary-school education, or move to Hungary.
The education reform will change this. From 2020, after a three-year transitional period, a minority language can be used as the main teaching language only in kindergarten and elementary school, from which point (after the fourth year of school) most instruction should be in Ukrainian. Some schools for indigenous people, such as Crimean Tartars, will be allowed to keep the old system, but for the most part, graduates of Ukrainian high schools will, under the new system, be adept in the Ukrainian language.
This change will help to eliminate de facto segregation of minority-language speakers, thereby unifying Ukrainian society – critical to a strong and vibrant democracy. It will also equip all students, including ethnic and linguistic minorities, not just to thrive in the labour market, but also to participate more fully in Ukrainian democracy, potentially securing government positions that enable them to advance further the interests of their fellow ethnic minorities.
It should also be noted that, while the rule will lead to less minority-language instruction, it does not preclude it. Education in minority languages will be provided through separate classes and groups, with some programmes allowing for instruction in multiple languages. For example, if a Hungarian speaker were studying Hungarian literature, they would be able to do so in their native tongue.
All in all, the case for Ukraine’s new education law could not be stronger. Yet neighbouring countries are deliberately distorting the legislation’s significance, claiming that it is somehow a threat to ethnic minority groups. And they are prepared to punish Ukraine for it.
Hungarian Foreign Minister Peter Szijjarto has declared that, if the law is not changed, his country will block further Ukrainian integration into Europe. “We can guarantee that all this will be painful for Ukraine in future,” he added. Szijjarto, along with his counterparts from Romania, Bulgaria, and Greece, also voiced opposition to the Council of Europe and the Organisation for Security and Co-operation in Europe.
Moreover, Romania’s president cancelled a visit to Ukraine scheduled for this month, and withdrew an invitation for the speaker of Ukraine’s parliament to visit Bucharest. And, perhaps most ominous, Russian Foreign Minister Sergei Lavrov accused Ukraine of trying to “Ukrainise” the education system, in violation of the country’s constitution and international agreements.
Beyond being a gross misrepresentation, this approach is blatantly hypocritical, as the countries that are complaining about Ukraine’s new language rules have similar systems in place. Though Hungary is home to some 8,000 Ukrainians, there is not a single Ukrainian-language school in the country. The same is true for Russia, with its Ukrainian minority of over 2mn. In Romania, with its roughly 50,000 Ukrainians, there is only one Ukrainian-language school.

Read More: http://snip.ly/6iem1#http://www.gulf-times.com/story/566224/An-inclusive-Ukrainian-education