4 Important CLSI Guidelines According to Assay Validation

They will use real life examples to demonstrate how to overcome some of the practical challenges when guidelines can not be exactly follow.


Each of the assay performance characteristics (specificity, sensitivity, accuracy, precision, linearity, stability, reportable range, reference range) will be explained in terms of experimental design and statistical analysis.

Most assay validations are a compromise between scientific principles, regulatory requirements, and limited resources in reality. They will use real life examples to demonstrate how to overcome some of the practical challenges when guidelines can not be exactly follow.

Though the CLSI guidelines provide much more actionable details than other guidelines (e.g. by FDA, USP), the understanding and adoption of the guidelines remains a challenge for the broad users. Plus, due to reality restraints, oftentimes the study design and/or the statistical analysis suggested by the guideline cannot be exactly followed.

In this webinar, major CLSI EP guidelines will be introduced. The focuses are

(1) interpreting the procedure for each guideline,

(2) intuitive explanation of the statistical methodologies,

(3) using real-life examples to illustrate the use of the guidelines, and

(4) discussing some solutions when facing challenges in implementing the guidelines.


These are the areas covered by the mentor


  • Sensitivity (EP17)
  • Accuracy (EP9)
  • Precision (EP5)
  • Specificity (EP7)
  • Matrix effect (EP14)
  • Statistical Process Control (SPC)

Don’ Miss these Guidelines Going Viral


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

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

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

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

As important as the technologies

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

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

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

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

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

Use of blockchain can ease the supply chain finance

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



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

Using autoantibody [biomarkers] to drive safer and more effective treatments

The game-changing importance of cancer immunotherapies and the coming of age of this approach was further confirmed by the awarding of the 2018 Nobel Prize in Physiology and Medicine.

For a number of years now, immunotherapy has been seen as the dawn of a new era, and is the most promising approach to cancer treatment since the use of targeted therapies, making headlines as results for successive novel immunotherapeutic drugs and combination therapies are released.

These innovative therapeutic strategies, which harness the body’s own immune response to fight cancer, have truly revolutionized the field, giving hope to the millions of individuals diagnosed with cancer every year.The game-changing importance of cancer immunotherapies and the coming of age of this approach was further confirmed by the awarding of the 2018 Nobel Prize in Physiology and Medicine to James Allison and Tasuku Honjo, for their remarkable contributions to the field ofimmuno-oncology.

Given their enormous potential, a broad range of immunotherapeutic strategies, including chimeric antigen receptor T-cell therapies (CAR-T cells), therapeutic vaccines and immune checkpoint inhibitors (CIs) are already on the market and numerous others are under active clinical development. Concerted research efforts have translated into large numbers of clinical trials, with various reports putting the number of ongoing trials at between 800 and 1000in the United States of America alone.Some of these treatments have already gained market approval, with a raft of new immunotherapeutic drugs expected to reach the market in the next couple of years.

This comes amid annual growth in the immuno-oncology sector of around 15% a year, according to Zion Market Research, with the market expected to be worth over 97 billion US dollars by 2022.

Despite this justified optimism, there remain a number of key challenges limiting the future potential of immuno-oncology treatments. While immunotherapies are proving to be highly effective in some groups, it is now clear that many patients do not respond to treatment or suffer from inflammatory side effects known as immune-related adverse events (irAEs). IrAEs can range from non-life-threatening conditions such as skin rash, through to more severe, life-threatening ones involving the endocrine glands, joints, liver, lungs and other organs, resulting in the potential termination of treatment. In some cases, fatal irAEs have been reported. However, as few standardized diagnostic criteria for irAEs currently exist, concerns have been raised that the number of incidences are underestimated.

Such irAEs are most prominent for CIs,owing to their mechanism of action and their widespread use in mono-, put particularly combination therapies.Immune checkpoints act as negative immune regulators of autoreactive Tcells – in essence, acting as ‘brakes’ – that preventautoimmunity. However, once these checkpoints are inhibited and these brakes are removed, the activated T cells can cause an over stimulation of the immune system,resulting not only in beneficial anti-cancer effects but also in an autoimmune response.

Because of these risks, irAEs have been known to put a stop to the clinical development of some immunotherapeutic drugs, they may also limit the progress of immuno-therapies in earlier stage cancer patients. Once severe irAEs are encountered, patients often decide (or are required) to discontinue their clinical trial participation or treatment. In some cases, regulatory bodies such as the US Food and Drug Administration have intervened to halt trials, even when promising results were observed. Clearly, this is a challenge for patients, bio pharmaceutical companies and regulatory authorities, and a solution is highly sought-after.

Audit Trail Generation and Review 2019

How to handle systems without automated audit trails, in a compliant manner.

Audit trails and describe the benefits of audit trail for your company. Attendees will learn the tools required to generate compliant audit trails on a domestic and international basis and will answer the questions on how to handle systems without automated audit trails, in a compliant manner.

How to review audit trails, using a risk based approach to cull through the thousands of audit trail records that can be generated on a daily basis.


  • What is an Audit Trail
  • 21 CFR 11 / Annex 11 requirements for Audit Trails
  • Why Audit Trails
  • What are Audit Trail Features
  • What are Audit Trail Contents
  • What records need to have an Audit Trail
  • When does Audit Trail begin
  • What clock should be used for the timestamp
  • How is Audit Trail versioned
  • How is Audit Trail stored
  • What if my system does not have automated Audit Trail
  • What about “hybrid” systems

Angela Bazigos is the CEO of Touchstone Technologies Inc. She has degrees in Microbiology and Computing and 40 years of experience in the Life Sciences, Healthcare & Public Health Services. Experience combines Quality Assurance, Regulatory Compliance, Business Administration, Information Technology, Project Management, Clinical Lab Science, Microbiology, Food Safety & Turnarounds. Past employers / clients include Royal Berkshire Hospital, Roche, Novartis, Genentech, PriceWaterhouseCoopers & Stanford Hospital.

How to handle systems without automated audit trails https://goo.gl/gTa8He


The Role of (Self Care) to Build a Prosperous Business

Smart devices have essentially re-programmed how we interact with and experience our world.

How much more can we add to our jammed calendars? How many more communication methods can we reasonably maintain? How many items on our ‘to-do’ list do we actually check off at the end of each day?

In our uber-connected world, supported by technology unfathomable even five years ago, the pace of a typical workday has some of us on “mach” speed. How can we realistically maintain this pace and still produce superior quality work product? That’s an ongoing question and struggle for so many of us, and our clients.

Smart devices have essentially re-programmed how we interact with and experience our world.

As our work and personal lives fuse together, we are challenged to create boundaries that protect our health and well-being with self care. For those who have worked in a law firm environment, we understand clearly the highly stressed, deadline-driven culture of “more is more.” This mindset is detrimentally opposed to a well-balanced body-mind-spirit experience, quickly leading to a total ‘burn-out’ health crisis.

According to a recent Gallup study of 7,500 full-time employees, two thirds experienced burnout to some degree within the last three years. Burned-out employees take more sick days and are 23 percent more likely to carry around a heavy feeling of self-doubt and lack.

Wellness and mind-body practice is a health path forward.

As we struggle to “do it all”, how much does all facets of our health suffer? What are our daily practices to protect our body, mind and spirit? According to a study by the National Institutes of Health, individuals who engaged in a meditation retreat were assessed before and after. Active participants reported a decrease in anxiety and depression as well as an increase in mindfulness. The practice of mindfulness is as simple as maintaining a moment-by-moment awareness of our thoughts through a gentle, nurturing lens.

Benefits of hitting the pause button.

In our personal quest to achieve “success,” we can lose the internal cues that are foundational to our connection with ourselves and we diminish our ability to self-regulate (control emotions, concentration, and joy). With consistent and persistent practice, we can achieve a powerful ability to decrease anxiety, increase joy and fulfillment, increase performance capabilities and produce a more mindful state. At the root of all these attributes is self-regulation.

Simple yet powerful effects of breath play an essential role to the fundamentals of health, well-being, healing and human performance. Specific breathing techniques can have a tremendous impact on decreasing stress and other inflammatory states, enhancing brainpower and balancing emotions. Sharpening this internal regulation tool will assist to achieve deeper sleep and improve digestive issues while resisting “thought clutter.”

Further, specific breathing practices will enrich the connection to yourself (self-awareness, self-esteem, etc.) as well as deepen your connection to a powerful reserve of energy that will support a higher level of health, healing, wellness and performance in all areas of your life.

Consider how many times a day you actually stop all activity to simply “be,” without motion or in the state of doing? Experts agree that the longer we stay in motion of “doing”, the less healthy we are “being.” Yes, it stands in direct contrast to satisfying our billable hour requirements and project lists, but, in the long-term, we will benefit from a more efficient and productive work schedule. Try it for yourself.

Consumerization of Healthcare, AI, and the Shifting “Physician-Patient” Relationship

The next important step in enabling patients to inquire about their own personal health.

The classic story of disruptive technology is all too familiar. Travel websites replace agents by giving consumers access to the same rates. Uber offers transportation outside of the established taxi cab system. Amazon brings outlet shopping into our homes. The common thread in all these examples is the transfer of more power to consumers. These changes usually cut costs, increase efficiency and often force out those who cannot keep up. Most of these fundamental developments occur in fields that do not require highly technical expertise, such as housing and transportation, allowing consumers to take control without extensive training.

The specialized knowledge and professional barriers in medical practice have, for many years prevented consumer involvement — leaving control and decision making solely in the hands of the healthcare provider, with the patient largely on the receiving end of information that directly affects their care.

However, these barriers are beginning to crumble.

Over several decades, patients have become more active in pursuing better care and are looking for knowledge sources that can help them become more educated and active participants in their care. Recently, advancements in AI (artificial intelligence), big data analytics, mobile technology and cloud computing have started to enable patients to take greater control of their medical care, leading towards a major shift in the patient-physician relationship.

The first hint of the evolving physician-patient relationship started when medical information became accessible to the layperson. Websites such as WebMD began to make medical literature comprehensible, accessible and searchable. Beyond this, social media and patient blogs allowed people to compare their experiences with others’, creating a better understanding of what their symptoms may be telling them. However, this data was still too general and not personalized.

Patient access to their personal health records (via patient portals) was the next important step in enabling patients to inquire about their own personal health.

Next, mobile technology has allowed patients to track, store and manage their medical history with increasing accuracy. Furthermore, FDA-cleared wearables have advanced to provide vital signs and other sensor-related data, adding more dimensions to the personal clinical data stored on the consumer’s mobile.

Now, consumer-focused companies such as Apple, are providing consumers with access to their full medical records from multiple healthcare providers on their mobile devices. Together with the wearable sensor and patient-entered data, the patient now has access to a far more enriched, comprehensive and accurate up-to-date data than any of the individual healthcare providers treating him/her.

However, understanding the clinical implications of the data to the individual is challenging for most consumers. Consumers are flooded with their own clinical data, with limited ability to utilize this data to benefit their own health.

Very interesting & Huge information never miss this

Healthcare Supply Chain Reaches Master [Level Ranking]

When we move initiatives forward, we do so with the dedication and commitment to improve value.

Annual Gartner Healthcare Supply Chain Top 25 list recognizes Intermountain Healthcare for initiatives to provide highest quality products and services at the lowest possible cost.

Intermountain Healthcare has reached a “Masters” designation in the annual Gartner Healthcare Supply Chain Top 25 list. The Healthcare Supply Chain Top 25 ranking and designation, recognizes manufacturers, providers, distributors and retailers from across healthcare that demonstrate leadership in improving human life at sustainable costs. After being ranked in the top five over the past seven years, Intermountain is recognized in Gartner’s new Master classification, an additional dimension of achievement. Gartner is a national business consulting company who has issued the ranking the past ten years.


Intermountain earned the Master level based on sustained supply chain performance over a period of time. Intermountain was ranked #1 on the Gartner list in 2016 and 2017 and #3 the two prior years. Intermountain’s strong bond rating, its supply chain organization’s initiatives to improve value and lower healthcare costs, the health system’s comprehensive approach to serve the patient, and innovative problem solving are among the factors to achieve the newly created title.

“Our supply chain team does an outstanding job to ensure we’re using the highest quality products and services at the lowest possible cost,” said Marc Harrison, MD, president and CEO of Intermountain Healthcare. “This team continually raises the bar in quality and affordability and demonstrates—year upon year—their commitment to making a difference for those we serve. We are honored to be on this prestigious list as a Master.”

John Wright, vice president of Supply Chain and Support Services for Intermountain, adds, “This is a humbling experience to now be ranked as a Master and a designation which I’m very appreciative. Intermountain Supply Chain leaders before me staged us for this honor long ago and I’m proud to have led us the past year to continue our work forward. Recognition of this type validates our passion and conviction within the supply chain to make a difference for our patients. I know that when we move initiatives forward, we do so with the dedication and commitment to improve value.”