200+ followers. WOWWWWWW…

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Hello Everyone,

Today we have the pleasure of celebrating the fact that we have reached the milestone of 200+ followers on WordPress. Since we started this blog, we have had such a great time connecting with everyone.  we never expected to actually to connect with other people in the blogging community.

we are so incredibly thankful for each and every one of you who follows and comments on my blog posts. Please know that!

we would continue our blogging in these areas FDA Regulation, Medical Devices, Drugs and Biologics, Healthcare Compliance, Biotechnology, Clinical Research, Laboratory Compliance, Quality Management ,HIPAA Compliance ,OSHA Compliance, Risk Management, Trade and Logistics Compliance ,Banking and Financial Services, Auditing/Accounting & Tax, Packaging and Labeling, SOX Compliance, Environmental Compliance, Microsoft Excel Spreadsheet, Geology and Mining, Human Resources Compliance, Food Safety Compliance and etc.

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Best Practices in Vendor Risk and Compliance Management

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Best practices in vendor risk and compliance management need to be inculcated by vendors who deal with them because of the enormous risk their activities carry. Implementation of best practices in vendor risk and compliance management goes a long way in checking risks and with it, the adverse fallouts of a vendor management program.

First of all, why do organizations have a vendor partnership? It is because this kind of arrangement helps them to take care of their logistics and other aspects of their business in a much more streamlined and economical fashion, and this in turn helps them to concentrate and focus on their core business better. A strategic vendor partnership helps organizations manage their products and services better, and more economically. The root to this is inculcation of best practices in vendor risk and compliance management.

vendor-risk-and-compliance-managementThe importance of best practices in vendor risk and compliance management can be understood from the fact that when companies outsource their operations, or particular parts of them, or some of their activities, this does not include organizational responsibility. So, the onus of ensuring compliance with regulatory guidelines and making sure that the vendor has implemented best practices in vendor risk and compliance management lies squarely with the organization that outsources.

Burden is on the organization that hires vendorsThis places a heavy responsibility on them, since of late regulatory guidelines for best practices in vendor risk and compliance management have become all the more stringent. While outsourcing part of their activity or operations or logistics or even parts of product development to vendors; companies have to be very sure that they are in tune with best practices in vendor risk and compliance management.

vendor-risk-and-compliance-managementThe basis to implementing best practices in vendor risk and compliance management is to get a clear comprehension of vendor responsibilities. Many organizations make the mistake of assuming that best practices in vendor risk and compliance management need to be implemented only at the stage of selecting the vendor. This is disastrous thinking, because selection of the vendor is just the beginning of the outsourcing program. These organizations have to make sure that best practices in vendor risk and compliance management is a continuous program and activity, and hence utmost care has to go into managing them at all times.

Reasons for increased need for implementation of best practices in vendor risk and compliance managementThe need for adaption and implementation of best practices in vendor risk and compliance management has become all the more acute and necessary in view of the following factors:

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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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Which universities are pushing the boundaries in life sciences?

If you had to name the branch of university research that has the most tangible impact on mankind’s day-to-day activities, it is likely that the life sciences would be near the top of the list: not many days go by without the announcement of a new drug or gene discovery that has the potential to change lives or tackle disease.

Much of the best research in these fields takes place in the ultra-elite universities that excel in subjects across the board.

But analysis by Times Higher Education of the institutions that make up the World University Rankings reveals that there is a cluster of institutions just below this elite that are particularly strong in the life sciences and in driving forward innovation.

The 120 “life science challengers” tend to pitch much higher in the subject rankings related to clinical research and life sciences, as might be expected, with the bulk of them achieving overall scores in the middle to upper ranges (see below).

Which universities are pushing the boundaries in life sciencesHowever, they also perform very strongly in terms of the citation impact of their research, something that can be credited to their excelling in fields where journal article activity is key. Unlike the “technology challengers” (another cluster in the rankings), they also tend to be older universities, with few having been established less than 50 years ago.

Beyond these similarities though, the factors that drive the individual successes of the institutions are varied. In some cases excellent strategic decisions taken by the university are a factor; in others the local or regional ecosystem for research plays a part.

Sweden, which has five institutions in the list (headed by the medical research specialist Karolinska Institute), is one example where the ecosystem for life sciences appears to be a key factor.

Ulf Landegren, professor of molecular medicine at Uppsala University, another of the Swedish institutions in the list, said that the country had historically excelled in many life science fields, but that it was now taking its performance to another level with the help of collaborative programmes. The Science for Life Laboratory is one such programme – government-funded, it is based in Uppsala and also in Stockholm.

The SciLifeLab, as it is known, allows researchers from across Sweden to use cutting-edge and often expensive technology without paying for the privilege (apart from the costs of “disposables” used in lab work). Companies and scientists based outside Sweden can also use the facilities, but must face the full cost of doing so.

Professor Landegren, who was heavily involved in setting up Uppsala’s SciLifeLab site, said the effect of the scheme “has been that Swedish scientists now have ready access to advanced techniques that they may not themselves have the economy or the skills to set up”.

“Increasingly we see that life science is going the way of physics, in that technology is getting a little too expensive and complicated for individuals to have all the resources they need to answer their research questions so you might as well centralise it,” he explained.

He added that as well as making “generic” technology and techniques available to all Swedish scientists, SciLifeLab went a stage further by also identifying emerging “beyond state-of-the-art” approaches to research and capitalising on them before they spread to other countries and universities.

Access to expensive technology and the latest techniques is a theme carried across to other institutions that make the list.

Ross Coppel, director of research in the Faculty of Medicine, Nursing and Health Sciences at Australia’s Monash University, puts its success down to past strategic decisions to invest properly in the best academic staff and equipment, but also to the skilled technicians who operate facilities.

He said universities’ research strategies “are often very similar and it [success] comes down to your capacity to implement and execute your vision. I think we were in the fortunate position of having the financial resource to do it [and] the determination to do it and it’s worked out for us very well”.

On the role of technicians, he said Monash had focused on their field being a career path in its own right, with good job security and benefits. In return, in terms of testing new techniques and advancing research technology, “we look to them also to be pushing the boundaries of what is achievable”, explained Professor Coppel.

Beyond smaller research nations like Sweden and Australia, the life science challengers cluster is dominated by institutions in the US and UK.

With 35 institutions of the 120 (the UK has 24), the US is out in front, with a number of private institutions excelling in research. Here, the unique position that some American universities occupy – having strong ties to hospitals and the general healthcare system – is an obvious explanation for their success.

Emory University in Atlanta, for instance, is behind the state of Georgia’s biggest healthcare system – not-for-profit Emory Healthcare – while the US’ Centers for Disease Control and Prevention has its headquarters adjacent to the university’s campus. This geographic proximity between researchers and the practical application of their findings has obvious collaborative benefits.

But the university is also keen to stress the importance of its global reach through its success in spinning out research into the healthcare market and its academic links overseas.

David Stephens, vice-president for research at Emory, said that the institution had “realised its greatest success in commercialising research discoveries in the field of infectious diseases. For example, nine out of 10 US HIV/Aids patients, and thousands more globally, are on life-saving drugs discovered at Emory”.

Meanwhile, an effect of its international collaborations can be seen in the recent joint set-up with the University of Queensland – another life science challenger institution – of a multimillion-dollar biotech company developing cancer treatments.

simon.baker@timeshighereducation.com

Seminar Calendar of Upcoming Courses – June to July – 2017

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GlobalCompliancePanel’s seminars are a wonderful opportunity for professionals in the regulatory compliance areas to understand the latest happenings and updates in the regulatory compliance areas and to implement them, something they need to climb in their professions. GlobalCompliancePanel brings together a few of the best recognized names in the field of regulatory compliance on its panel of experts. The result: Learning that is effective, valuable and helpful.

GlobalCompliancePanel’s experts help you unravel all the knowledge you need in all the areas of regulatory compliance. At these seminars which are held all over the globe, you get to interact with them in person, so that any doubt or clarification you have is sorted out by none other than the honcho. They help professionals like you implement the regulations and stay updated, so that regulatory compliance causes no stress for you.

GlobalCompliancePanel’s experts offer their insightful analysis into the issues that are of consequence to regulatory professionals in their daily work. Their thoughts help you implement the best practices of the industry into your work. They also offer updates on the latest regulatory requirements arising out of a host of the laws and issues related to regulatory compliance, including, but not limited to medical devices, food and beverages, pharmaceuticals, life sciences, biotechnology and pharmaceutical water systems.

Take a look at our upcoming webinars from GlobalCompliancePanel, which will put you on the road to learning about any area that is of importance to your profession. You can plan your learning from GlobalCompliancePanel by looking at our seminars in the next few weeks at locations of convenience to you. You can choose from a whole range of topics. See which among these trainings suit you: Design of Experiments (DOE) for Process Development and Validation, Writing and implementing effective SOP’s, new FSMA rules, risk management and device regulations, data integrity, combination products, and what have you!

Contact us today!
NetZealous LLC DBA GlobalCompliancePanel
john.robinson@globalcompliancepanel.com
Toll free: +1-800-447-9407
FAX : 302 288 6884
Website: http://bit.ly/Courses-June-to-July-2017

Key issues in HR auditing

Key issues in HR auditing

The importance of HR auditing can be gauged from the fact that it is about employees, an organization’s most valuable resource. It is through HR audits that an organization evaluates its strengths and weaknesses of its most important resource. HR audits have come a long way from the earlier times, when they were considered a set of checklists to be ticked. Today, HR audits in organizations consist of a whole gamut of sustainable and continuous audit activities that relate to critical areas such as governance, compliance and management in the organization.

Important benefits of HR auditing

HR auditing helps organizations:

o  Zero in on not only existing problems relating to HR, but also potential ones

o  Assess the efficacy of HR management practices

o  Understand the deficiencies of the HR internal control processes

o  Evaluate human capital and risks, both from the strategic and compliance-related perspectives

Rightly done HR audits enhance the value of an organization’s human capital and its competitiveness and bring down its susceptibility to employment practices liabilities by advising the management on what corrective steps it needs to take to resolve HR internal control processes.

Most importantly, HR audits should take human capital related risks and opportunities from the standpoint of Enterprise Risk Management (ERM), which leads to higher interaction between HR and management.

Proper ways of carrying out HR auditing

Although most organizations understand the importance of HR auditing and its uses; it is important for them to get the exact ways of implementing it. Getting their HR auditing right is the stepping stone to many important useful and corrective steps.

Risk management is the single most important ingredient that has to go into HR auditing. The proper ways of carrying out HR auditing will be imparted at a two-day seminar from GlobalCompliancePanel, a leading provider of professional trainings for the areas of regulatory compliance.

The Director of this seminar is Ronald Adler, a president-CEO of Laurdan Associates, Inc., a veteran owned, human resource management consulting firm that specializes in HR audits, employment practices liability risk management, HR metrics and benchmarking, strategic HR-business issues and unemployment insurance. Ronald brings vast and deep experience in all the areas of HR including HR auditing.

Professionals who wish to benefit from this learning can register for this seminar by logging on to Key issues in HR auditing .

The Director of this seminar will help organizations direct and focus their attention on their human resource management practices, policies, procedures, processes, and outcomes.

Asking the right questions

The foundation to sound HR auditing is to ask the right questions. Sharp, thoughtful, perceptive and insightful, they should prod management into getting into the depths of HR auditing. The ways by which to ingrain the habit of asking the right, meaningful questions will be the major learning this seminar will impart. Ronald will show the ways by which HR auditing needs to learn to throw up a structured and systematic series of questions about core areas such as key compliance, risk management, internal auditing, and human resource management issues to HR, which after all, is the real purpose of HR audits.

An understanding of how to ask these questions should be out of the realization that no two employees that HR auditing policies are focused on are alike. This way, Ronald will give clarity on the distinguishing nature of HR auditing.

HR auditing from the ERM perspective

A core aspect of HR auditing is that it should be inseparably linked to Enterprise Risk Management (ERM) for it to become effective and successful. To make this happen, HR auditing should take a broader and comprehensive view of human capital risks bring the interrelationships and interactions between HR and other functions relating to management and the organization in alignment with each other.

Ronald will explain these, as well as the ways by which HR auditing can help the organization identify and capitalize on potential opportunities and reduce risks.

HR professionals and others related to HR auditing, such as CFO’s, Internal Auditors, External Auditors, Risk Managers, Compliance Officers and COOs can benefit from the lessons learnt at this seminar.

He will cover the following areas at this seminar:

o  Review an overview of employment related risk management and HR Audits

o  Assess human capital risks

o  Develop HR metrics

o  Explore the HR audit model

o  Assess strategic alignment

o  Assess HR management related documents

o  Assess HR management processes and practices

o  Review the practical applications of HR audits.