Risk management methods and tools in the pharmaceutical and life sciences industries

Understanding and implementing risk management methods and tools is crucial for the pharmaceutical and life sciences industries in view of the fact that errors in this area can lead to dangers for human life. Since any mistake in any chain of in this industry can lead to serious consequences; the FDA and other regulatory agencies have created a number of risk management methods and tools for these industries.

A few commonly used risk management methodsIn the pharmaceutical and life sciences area, a few commonly used risk management methods and tools for organizing data and using these to help in decision-making include the following:

• Flowcharts
• Checklists or check sheets
• Mapping of the process
• Fish bone diagram or Ishikawa diagram.

A few popular risk management methods and toolsIn the field of pharmaceuticals and life sciences, these can be said to be some of the more popularly used risk management methods and tools:

Failure Mode Effects Analysis (FMEA)FMEA is a popular one among the risk management methods and tools mainly because it provides a methodology for assessing a potential failure mode for the process that goes into the manufacturing of the pharma or life sciences product and helps to analyze their possible impact on the product’s ability to perform to its required standard.

Identification and establishment of failure modes are taken as the basis for using risk reduction techniques for eliminating, containing, reducing or controlling the possible failures. Since FMEA depends on a deep understanding of the product and the process; its main steps include dissembling complex processes into simpler and comprehensible ones. For this reason, FMEA is considered a potent risk management method and tool.

Failure, Mode, Effects, and Criticality Analysis (FMECA)Extending the concept of FMEA a little farther, the Failure, Mode, Effects, and Criticality Analysis (FMECA) takes into account the added feature of the extent of gravity of the consequences of a fault or failure, along with the possibility of their occurrence, as well as the chance of their detection. While this is the slight extension that the FMECA brings to FMEA; it is similar to it in other respects, namely:

FMECA too, like FMEA, uses identification and establishment of the process specification to identify risks and failures

FMECA too uses the method of breaking down difficult processes to easier ones to enable better understanding of the failures and risks.

Fault Tree Analysis (FTA)Fault Tree Analysis is another of the risk management methods and tools. What this tool does is that it takes up a single fault at a time for analysis, but links the chains that cause the fault. This is why it gets its name, wherein the results of the analysis are represented in a shape of a tree, in which each level of fault is described with possibilities. A sharp and incisive analytical bent of mind is required to create the FTA.

Hazard Analysis and Critical Control Points (HACCP)HACCP is yet another important one among the risk management methods and tools. It takes a systematic and proactive approach in ensuring the following in a product:

It is considered a comprehensive risk management method and tool because it addresses all the issues relating to risk management methods and tools, applying scientific principles and methods for carrying out the following:

Controlling of the risk or the negative outcomes of hazard, which could be due to any of these:

Supporting statistical tools
While all the risk management methods and tools described above are a snapshot of some of the major ones, a few supporting statistical tools, too, are used to engender quality risk management. These are some of them:

• Design of Experiments (DoE)
• Control charts
• Process capability analysis
• Pareto charts
• Histograms

 

 

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200+ followers. WOWWWWWW…

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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The science of Sad: understanding the causes of ‘winter depression’

For many of us in the UK, the annual ritual of putting the clocks back for daylight saving time can be accompanied by a distinct feeling of winter blues as autumn well and truly beds in. This might be felt as a lack of energy, reduced enjoyment in activities and a need for more sleep than normal. But for around 6% of the UK population and between 2-8% of people in other higher latitude countries such as Canada, Denmark and Sweden, these symptoms are so severe that these people are unable to work or function normally. They suffer from a particular form of major depression, triggered by changes in the seasons, called seasonal affective disorder or Sad.

In addition to depressive episodes, Sad is characterised by various symptoms including chronic oversleeping and extreme carbohydrate cravings that lead to weight gain. As this is the opposite to major depressive disorder where patients suffer from disrupted sleep and loss of appetite, Sad has sometimes been mistakenly thought of as a “lighter” version of depression, but in reality it is simply a different version of the same illness. “People who truly have Sad are just as ill as people with major depressive disorder,” says Brenda McMahon, a psychiatry researcher at the University of Copenhagen. “They will have non-seasonal depressive episodes, but the seasonal trigger is the most common. However it’s important to remember that this condition is a spectrum and there are a lot more people who have what we call sub-syndromal Sad.”

Around 10-15% of the population has sub-syndromal Sad. These individuals struggle through autumn and winter and suffer from many of the same symptoms but they do not have clinical depression. And in the northern hemisphere, as many as one in three of us may suffer from “winter blues” where we feel flat or disinterested in things and regularly fatigued.

One theory for why this condition exists is related to evolution. Around 80% of Sad sufferers are women, particularly those in early adulthood. In older women, the prevalence of Sad goes down and some researchers believe that this pattern is linked to the behavioural cycles of our ancient ancestors. “Because it affects such a large proportion of the population in a mild to moderate form, a lot of people in the field do feel that Sad is a remnant from our past, relating to energy conservation,” says Robert Levitan, a professor at the University of Toronto. “Ten thousand years ago, during the ice age, this biological tendency to slow down during the wintertime was useful, especially for women of reproductive age because pregnancy is very energy-intensive. But now we have a 24-hour society, we’re expected to be active all the time and it’s a nuisance. However, as to why a small proportion of people experience it so severely that it’s completely disabling, we don’t know.”

Nobel prizes 2017: everything you need to know about circadian rhythms

There are a variety of biological systems thought to be involved, including some of the major neurotransmitter systems in the brain that are associated with motivation, energy and the organisation of our 24-hour circadian rhythms. “We know that dopamine and norepinephrine play critical roles in terms of how we wake up in the morning and how we energise the brain,” Levitan says. One particular hormone, melatonin, which controls our sleep and wake cycles, is thought to be “phase delayed” in people with severe Sad, meaning it is secreted at the wrong times of the day.

Another system of particular interest relates to serotonin, a neurotransmitter that regulates anxiety, happiness and mood. Increasing evidence from various imaging and rodent studies suggests that the serotonin system may be directly modulated by light. Natural sunlight comes in a variety of wavelengths, and it is particularly rich in light at the blue end of the spectrum. When cells in the retina, at the back of our eye, are hit by this blue light, they transmit a signal to a little hub in the brain called the suprachiasmatic nucleus that integrates different sensory inputs, controls our circadian rhythms, and is connected to another hub called the raphe nuclei in the brain stem, which is the origin of all serotonin neurons throughout the brain. When there is less light in the wintertime, this network is not activated enough. In especially susceptible individuals, levels of serotonin in the brain are reduced to such an extent that it increases the likelihood of a depressive episode.

Read More: http://snip.ly/25gi4#https://www.theguardian.com/lifeandstyle/2017/oct/30/sad-winter-depression-seasonal-affective-disorder

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Medicaid platinum, silver for the rest

Insurance Commissioner Roger Sevigny … Findings of report are “not conclusive.”

CONCORD — The path New Hampshire has taken toward expanding Medicaid is pushing prices up for everyone else who buys health insurance on the Obamacare exchange at healthcare.gov, according to an analysis recently completed for the Insurance Department.

The average medical costs for the newly insured Medicaid patients are 26 percent higher than the non-Medicaid population on the exchange, even though the Medicaid patients are on average younger.

That is in large part because Medicaid patients are getting platinum plans that they use more aggressively because they have no co-pays or deductibles, while those paying some or all of their policy premiums are mostly in silver plans that they use more judiciously, according to the actuarial firm conducting the analysis.

“Generally, when populations are enrolled in plan offerings with low member cost-sharing, utilization of services is greater,” according to the actuaries from Gorman Actuarial who wrote the report. “This is referred to as induced demand.”

Gorman found that the presence of the expanded Medicaid population in the individual market raised average claim costs for the entire market by 14 percent.

The findings, based on 2016 claims data, were presented Monday to a legislative commission studying the future of expanded Medicaid in New Hampshire, which, in its current form, expires at the end of 2018.

One goal of Obamacare was to get more people covered, and part of the strategy was to make it easier to qualify for Medicaid, so-called “expanded Medicaid,” with the federal government paying 100 percent of the additional cost through 2016. Starting in 2017, the match declines slightly each year until it reaches 90 percent in 2020 and remains there, assuming the law is not changed or repealed.

Using the private market

Nineteen states, mostly in the South and Midwest, decided not to expand Medicaid, while New Hampshire was among 31 states and the District of Columbia that added to their Medicaid rolls. New Hampshire and Arkansas decided to use the private insurance market to cover the newly insured.

To qualify for traditional Medicaid in New Hampshire, you had to have low income as measured by federal poverty levels, and have an additional qualifying condition, such as being a parent or caretaker, disabled or pregnant.

The analysis can be viewed below:

With expanded Medicaid, unmarried, childless, able-bodied adults earning up to 138 percent of the federal poverty level could qualify, and in New Hampshire 40,000 took advantage of the opportunity.

But New Hampshire did not put those 40,000 new enrollees into the same traditional Medicaid program that was already serving 100,000 residents through managed care organizations that control costs. Instead, they obtained coverage from one of the companies offering plans on healthcare.gov, mostly the Ambetter plans offered by New Hampshire Healthy Families.

When the program was being designed that way, ostensibly to leverage the private sector instead of growing a government program, conservative groups like Americans for Prosperity warned against blending the new Medicaid customers whose costs are fully covered with customers who face co-pays and deductibles.

“Expanding Medicaid at all was a bad idea,” says Greg Moore, state director with Americans for Prosperity. “Expanding Medicaid in the individual marketplace was a disastrous one, and now we are asking people who are forced to buy health insurance under the Affordable Care Act to subsidize this bad decision.”

Proponents of expanded Medicaid, including the state’s hospitals, health care providers and many in the addiction treatment and recovery community, say the expansion has been an overall plus to the state, particularly in getting insurance for people in need of addiction-related services.

Facing a decision

So the state has to decide what to do about the program, as it sunsets in its current form in a little more than a year. Insurance Commissioner Roger Sevigny said the findings in the Gorman analysis are “not conclusive” on whether expanded Medicaid should continue in its current form in New Hampshire.

“How to best cover this population is a complex question that the New Hampshire Legislature will wrestle with in 2018,” he said. “These are times of unprecedented uncertainty for individual markets in New Hampshire and across the country ­— a factor that compounds the difficulty of the reauthorization question.”

Most New Hampshire residents who have health insurance obtain it through their employer in a group plan. But the state has about 90,000 individuals who buy insurance on the individual market, via healthcare.gov.

Of that 90,000, almost half (40,000) consist of the fully covered, expanded Medicaid population. The other half, about 50,000, consist of individuals who purchased policies on the exchange, many with premium subsidies.

The big question

One of the big questions the state has to face, if it keeps expanded Medicaid at all, is whether or not to keep the newly eligible population in the individual market or put it under traditional Medicaid.

Tyler Brannen, health care policy analyst in the Insurance Department, says the choice is not that obvious. Leaving the Medicaid population with the paying customers increases costs, but losing nearly half the risk pool in the online exchange would come with consequences of its own.

“They have increased claims cost,” says Brannen of the new Medicaid patients, “but in the future, they may be the ones who provide some stability because they may not be the people dropping out because of price increases.”

dsolomon@unionleader.com

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Development of technical training in the life sciences

Training and Development is a highly developed and evolved, broad body of knowledge. Many employees place themselves at a disadvantage vis-à-vis their colleagues in the absence of the right professional training and development. If employees have to consistently close gaps in their learning, they need to keep upgrading their knowledge and skills. They should also use training and development to understand how to meet the regulatory requirements the organization is required to comply with.

Difficulties of training and development in the life sciences

This said; the need for technical training in the area of life sciences has not got the attention that many other areas have. Technical training and development skills in the field of life sciences is extremely important in helping professionals in that important area get proper guidance of the regulations in the areas of life sciences and benefit from them.

Technical training in the life sciences applications, however, has its challenges.  Mention needs to be made of two of them: A) The field of life sciences consists of activities such as formulating Standard Operating Procedures (SOPs), work instructions, and having to carry out tests and clinical trials, all of which are pretty complex. B) Regulations are often considered complex to grasp and implement.

A full understanding technical training for the life sciences

GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, will be organizing a two-day seminar, at which professionals in the life sciences will become more familiar with training and development. It will also ease the complexity of their training needs.

The Director of this seminar is Charles H. Paul, who is the President of C. H. Paul Consulting, Inc., a regulatory, manufacturing, training, and technical documentation consulting firm that is celebrating its twentieth year of existence in 2017. Want to understand the importance of technical trainings for the life sciences and know how to implement legally compliant life sciences training programs for your organization? Then, please register for this seminar by visiting Development of technical training in the life sciences.  This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Kindling the interest in training for the life sciences

Charles will essentially seek to ignite the training and learning needs of talented and technically competent training professionals who may need more focused instruction and direction in the area of technical training in the Life Sciences. He will examine the guidance that all training professionals need at all skill levels to truly build and sustain a training organization in today’s difficult corporate environment, and show how to effectively identify gaps in workforce training and compliance documentation and build effective and inexpensive training materials with the tools that are available.

A very important takeaway of this seminar is the learning of how to integrate Training & Development with compliance, so that the participants can leverage the benefits of compliance to improve the performance of the workforce and the overall performance of technical operations.

Personnel in the life sciences industries that are associated with training, such as Directors of Training, Training Supervisors, Training Coordinators, Training Developers, Instructional Designers and Instructors will benefit from this seminar. The following is the agenda of this seminar:

• Introduction to Training and Development in the Life Sciences and the Relationship between Training and Regulatory Compliance
• Training and Development Basics
• The Building Blocks of Human Performance
• Building a Training and Development Organization – Leverage what you have and Negotiate for What You Don’t
• Perform a Documentation and Training Analysis – Discover the Gaps
• Training Materials – SOPs and Work Instructions as Training Materials – It’s not as easy as you think! Leverage the Opportunity!
• Working with Subject Matter Experts and Outside Consultants
• Case Study Review and Discussion – This Approach Works!