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

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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:

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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.

risk-in-pharmaceutical-and-life-sciences-industriesIdentification 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:

risk-in-pharmaceutical-and-life-sciences-industriesFMECA 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:

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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:

risk-in-pharmaceutical-and-life-sciences-industriesControlling of the risk or the negative outcomes of hazard, which could be due to any of these:

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Supporting statistical tools
risk-in-pharmaceutical-and-life-sciences-industriesWhile 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:

 

 

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Trends that will shape Supply Chain and Logistics in 2017

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Trends that will shape Supply Chain and Logistics in 2017 is an interesting topic to think about. Though most of the trends are a takeoff from the previous years, unless something really disrupting happens out of the blue at some point of time in the year; the signals are strong that the trends that emerged in the previous few years are set to solidify and get reinforced.

What are the trends that will shape supply chain and logistics in 2017?

For a sector that is dependent heavily on infrastructure for its working; there has been little of path breaking significance in terms of what has been added to the existing infrastructure in any country of significance in the world, at least not to the extent that it can impact the industry in a significant way. The Chinese hobbyhorse, the One Belt One Road (OBOR) initiative, is not slated for completion in this year. The completion of this grand project could spell a major change for the shape supply chain and logistics, but nothing of such drastic significance is set to take place in 2017.

trends-will-shape-supply-chain-and-logistics-2017In the other “happening” countries – for the supply chain and logistics industry that is – 2017 is not likely to see a signal shift. But the developments that have been happening over the past few years are likely to gather pace. Technology is one area in which the change is to be expected. While again, technology itself may not really be new till this point of time in this year; a few trends have been emerging, promising to make some impact on the shape supply chain and logistics industry in 2017.

Big Data as a driver of changeBig Data is the word on everyone’s lips. How can one expect an industry that is so completely data driven as logistics and supply chain to be insulated from its influence?

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Transition to m-commerceA notable development that is expected in the supply chain and logistics in 2017 is the evolution of ecommerce into m-commerce. This again, is nothing new or defining for 2017, but the year is likely to see a continuation of the trend set earlier.

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People all over the world are finding it much easier to shop with the help of their mobile devices, and are adapting to this medium, albeit at different levels and speed. The explosion in the number of smartphones being purchased globally has added impetus to m-commerce.

Try-ons as a new trendA new feature of online shopping is the try-on option that consumers are now being given. Online shoppers are given the option of choosing 4-5 varieties of their chosen product. All these pieces are delivered with the order, and the consumer can try out each of them and select the one that she thinks suits her best. The idea is to replicate the actual shopping to the extent possible.

trends-will-shape-supply-chain-and-logistics-2017This trend has its challenges, for sure, because the cost of making it work could be unimaginably high. As with any new trend, it is going to be some time before the economies of scale of such huge logistical operations start kicking in. Yet, this is a very tangible factor that is sure to count among the supply chain and logistics trends of 2017.

 

 

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

The science of Sad

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.

Putting the clocks back for daylight saving time can be accompanied by a distinct feeling of winter blues.

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.”

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.

The most popular treatments for Sad is bright-light therapy.

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

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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

Technical training in the life sciences

It is accepted that Training and Development is a highly developed area that bring its own body of knowledge. It uses a wide variety of techniques and approaches that are designed to meet the unique and complex challenges associated with training. Training and development is a great tool for helping a professional or a lay person alike understand the tenets of their profession.

In the absence of the right professional training and development, many employees place themselves at a disadvantage vis-à-vis their colleagues. They need to keep upgrading their knowledge and skills and keep closing the gaps, so that they do not get left out in their career. Training and development also helps employees understand how they need to meet the regulatory requirements the organization is required to comply with.

Difficulties associated with training and development in the life sciences

While this is accepted, a great deal of attention is yet to be paid to the need for technical training in the area of life sciences. Applying technical Training & Development skills to the field of life sciences is very crucial, as it helps professionals in that important area take a fresh perspective of the regulations in the areas of life sciences and benefit from them.

Technical training in the life sciences applications is fraught with a few problems. This is because two important factors come into play: The activities involved in the life sciences, such as formulating Standard Operating Procedures (SOPs), work instructions, the ways of carrying out tests and clinical trials, and the exact science behind the topics in this subject are all very complex. Secondly, regulations are equally difficult to understand and implement. This however, is no excuse to skip their implementation, something that is unthinkable for this industry.

A thorough learning session on technical training for the life sciences

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

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, will be the Director. To understand the importance of technical trainings for the life sciences and to get to know how to implement legally compliant life sciences training programs for your organization, please enroll for this seminar by visiting http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900920SEMINAR?wordpress-SEO. This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

Arousing the interest in training for the life sciences

The purpose of this seminar is to help kick start 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. Charles will offer guidance to all training professionals at all skill levels in how to truly build and sustain a training organization in today’s difficult corporate environment, and 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 benefit participants of this seminar will take away from here is that they will learn how to integrate Training & Development with compliance, so that they can leverage the benefits of compliance to improve the performance of the workforce and the overall performance of technical operations.

Important 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 derive high benefits from this seminar. Over the two days, Charles will cover the following:

o  Introduction to Training and Development in the Life Sciences and the Relationship between Training and Regulatory Compliance

o  Training and Development Basics

o  The Building Blocks of Human Performance

o  Building a Training and Development Organization – Leverage what you have and Negotiate for What You Don’t

o  Perform a Documentation and Training Analysis – Discover the Gaps

o  Training Materials – SOPs and Work Instructions as Training Materials – It’s not as easy as you think! Leverage the Opportunity!

o  Working with Subject Matter Experts and Outside Consultants

o  Case Study Review and Discussion – This Approach Works!

Good Manufacturing Practices are essential for ensuring quality

Key Takeaway:

GMPs are critical for the manufacture and distribution of foods, drugs and other pharmaceutical products. These need to be implemented diligently by organizations that are involved in these products.

Quality is a great concern for a manufacturer and consumer of any product. To ensure that quality is maintained across a variety of products ranging from foods to pharmaceutical products; a few guidelines are required. These guidelines are collectively termed Good Manufacturing Practices(GMP).

Not a uniform set of standards

It needs to be understood that GMPs are not a uniform or homogeneous set of rules for everyone to follow. These are general principles laid out for ensuring that there is a minimum level of quality requirements to be fulfilled.

Agencies that control authorization and licensing for manufacture and sale of food, drug products, and active pharmaceutical products recommend these guidelines. These guidelines can be accomplished in many ways, and it is up to the organization to find out the one that suits it best and implement that system.

In essence, Good Manufacturing Practices can mean the following:

  • GMPs are set practices that manufacturers need to put in place to ensure that their products meet specified quality standards.
  • GMP guidelines consist of the minimum requirements that food product, drug or pharmaceutical manufacturers have to meet to assure that their products are of the prescribed quality and cause no harm or risk to those who consume them or the public at large
  • Regulatory agencies in several countries oversee their respective countries’ and global Good Manufacturing Practices. Good Laboratory Practices (GLP) and Good Clinical Practices (GCP) are usually analogous to GMP
  • In many countries, legislations require pharmaceutical and medical device manufacturers to comply with GMP procedures. Many require these organizations to create their own GMP guidelines that are line with their legislations.

Basic points in GMP guidelines

These are the current GMP compliance requirements for pharmaceuticals (some of these guidelines overlap with those for medical devices)

 

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