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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Health Education England launches online workshop on improving digital readiness

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Health Education England is launching an online workshop to gather views on digital readiness.

The organisation is working in collaboration with Digital Health and innovation and crowdsourcing agency Clever Together on the online workshop, which forms part of the Building a Digital Ready Workforce programme.

It will be launched on 22 November in partnership with BCS Health and Care, the Federation of Informatics Professionals in Health and Social Care, and the Faculty of Clinical Informatics.

James Freed, chief information officer at Health Education England, told Digital Health the exercise was a chance to gather the views of those who already have a strong voice as well as those who are less commonly heard.

“In almost all technological programmes I have seen, our efforts are mostly about technology and very little about process, and the process redesign, and almost none on people,” he explained. He hopes the new online workshop will address that.

Andy Kinnear, chair of BCS Health and Care, added the aim was to hear from “digital experts; the wider group of people involved in the digital space such as nurses, doctors and care professionals; and the entire health and social care workforce”.

The online workshop will run for about three weeks and its results will form the basis for how the BRDW programme will prioritise and invest £6m over the next four years. Its findings will be extensively covered by Digital Health.

You can register now for the online workshop. Our feature article gives more detail – including interviews with James Freed and Andy Kinnear. Keep an eye on Digital Health over the next few weeks for ongoing coverage.

Video of father comforting newborn son receiving his first vaccines goes viral

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On October 26, first-time father Antwon Lee took his two-month-old son Debias King to get his first vaccinations. Lee, 29, said he was very nervous for the appointment, telling People Magazine that he “felt kind of scared a little bit,” as he knew the child was “going to go through some pain.” Before the visit, he also continually reassured his son that he could cry if he needed to.

TEARS AS CONJOINED TWINS DIE DAY AFTER BIRTH

When it came time for the vaccinations, Lee held his son in his arms and told the little boy to “stay strong,” while Shamekia Harris, Lee’s girlfriend, recorded the visit on her phone. Little Debias did cry as the nurse gave him his shots, but stopped soon afterward when Lee consoled him.

The video has since gone viral, with about 13 million views, 51 thousand likes, and 186 thousand shares as of Wednesday.

Sadly, Lee’s father, Anthony Lee, 57, died that same day due to complications from drinking. Lee explained to People that he was emotional and very close to his father, and that he later spoke to his son Debias about his hopes for the future.

“I talked to him like a grown up … I told him, before I leave, want to see him succeed,” Lee said.

Lee wishes that the video will remind others of the importance of fatherhood, “I want them to take care of their kids, because when you sign up for something, you have to stick with it,” he told People.

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Lee, however, isn’t the only person to go viral for his vaccination video: In 2014, pediatrician Michael Darden gained attention for his unique approach to giving shots, and the video still doesn’t disappoint:

Read More: http://snip.ly/9obne#http://www.foxnews.com/health/2017/11/01/video-father-comforting-newborn-son-receiving-his-first-vaccines-goes-viral.html

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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The use of Applied Statistics for FDA Process Validation

Why you Should be Worried about HIPAAThe use of Applied Statistics for FDA Process Validation is considered a matter of very high importance in the pharmaceutical industry. The FDA’s guidance for the industry, which it called “Process Validation: General Principles and Practices”, was set up in 2011. This guideline sets the framework for Process Validation in the pharmaceutical industry. The FDA prescribes a three-stage process that any organization in the pharmaceutical industry has to set up:

  1. Process Design
  2. Process Qualification
  • Continued Process Verification.

The Process Design stage, which is called Stage 1, is when the organization defines the commercial manufacturing process. The knowledge that the organization has gained through development and scale-up activities serves as the basis for the development of this definition.

The Process Qualification, or Stage 2, involves evaluating the process design for the purpose of determining if the process defined in Stage I has the capability for reproducible commercial manufacturing.

The next stage of the FDA process validation stage is to determine if the Process Design stage and the Process Qualification stage give the ongoing assurance that the process remains in a state of control during routine production. This is what Stage 3, the Continued Process Verification, does.

Thorough understanding of how to implement Applied Statistics for FDA Process Validation

GMPs for Combination Products and 505(b)(2) Products

The ways of using Applied Statistics for FDA Process Validation will be the topic of a two-day seminar that GlobalCompliancePanel, a leading provider of professional trainings for the regulatory compliance areas, will be organizing. At this seminar, Richard Burdick, Emeritus Professor of Statistics, Arizona State University (ASU) and former Quality Engineering Director for Amgen, Inc., will be the Director.

Please visit http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901132SEMINAR?wordpress-SEO to register for this meaningful and highly valuable seminar on applied statistics for process validation. This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.

A methodical approach to implementing statistical methodologies

Top 20 Costly Mistakes

The focus of this two-day course on Applied Statistics for FDA Process Validation is the various ways by which a systematic approach to implementing statistical methodologies into a process validation program consistent with the FDA guidance can be established.

Dr. Burdick will begin with a primer on statistics, where he will explain how the methods of Applied Statistics for FDA Process Validation seminar can be applied in each remaining chapter.

The two fundamental requirements for Process Validation, namely the application of statistics for setting specifications and assessing measurement systems (assays), will be taken up next.

The next aspect of applied statistics Dr. Burdick will move on to is how to apply statistics through the three stages of process validation as defined by requirements in the process validation regulatory guidance documents.

Since the methods taught through all these three stages are recommended by regulatory guidance documents; this seminar on Applied Statistics for FDA Process Validation will provide references to the specific citations in the guidance documents.

The aim of this learning on Applied Statistics for FDA Process Validation is to lead participants into ways of establishing a systematic approach to implementing statistical methodologies into a process development and validation program that is consistent with the FDA guidance.

Complete learning on Applied Statistics for FDA Process Validation

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Over the two days of this seminar, the participants will learn how to:

  • Apply statistics for setting specifications
  • Assess measurement systems (assays)
  • Use Design of Experiments (DOE)
  • Develop a control plan as part of a risk management strategy, and
  • Ensure process control/capability.

All concepts at this Applied Statistics for FDA Process Validation seminar are taught within the three-stage product cycle framework defined by requirements in the process validation regulatory guidance documents.

Although aimed at the pharmaceutical industry, this seminar on Applied Statistics for FDA Process Validation provides a useful framework for other related industries, as well.

In this important learning on Applied Statistics for FDA Process Validation; Dr. Burdick will cover the following areas:

  • Apply statistics to set specifications and validate measurement systems (assays)
  • Develop appropriate sample plans based on confidence and power
  • Implement suitable statistical methods into a process validation program for each of the three stages
  • Stage 1, Process Design: utilize risk management tools to identify and prioritize potential critical process parameters; and define critical process parameters and operating spaces for the commercial manufacturing process using design of experiments (DOE)
  • Stage 2, Process Qualification: assess scale effects while incorporating large (pilot and/or commercial) scale data; develop process performance qualification (PPQ) acceptance criteria by characterizing intra and inter-batch variability using process design data and batch homogeneity studies; and develop an appropriate sampling plan for PPQ
  • Stage 3, Continued Process Verification: develop a control plan as part of a risk management strategy; collect and analyze product and process data; and ensure your process is in (statistical) control and capable.

keep enhancing FDA Process Validation

Shipley Center Website Offers Prostate Cancer Facts for Patients

One in every seven men in the United States will get prostate cancer, making it the second most common type, after skin cancer, for American men. It tends to be a slow-growing disease, but can sprint to life-threatening severity if detected too late. Screening for prostate cancer can yield false-positive findings, but those most at risk for the disease—men whose father or a brother had prostate cancer, African American men, overweight men, and those in their 60s and 70s who are in good health and could expect years more of life—still should ask their doctors whether screening makes sense for them.

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The website for the Shipley Prostate Cancer Research Center provides basic information about the prostate gland and how disease affects it.

That information comes from the just-launched website of the Shipley Prostate Cancer Research Center at the School of Medicine. Created with a $10.5 million gift from BU trustee Richard Shipley (Questrom’68,’72), the center’s labs will be in the Conte Building on the Medical Campus when it opens. The center’s research will be focused on finding genomic approaches to determine which prostate cancers are aggressive and need treatment, and which can simply be monitored.

The center’s website and its Facebook page and Twitter account are up and running now, offering easy-to-follow, impartial information on practically everything anyone needs to know about prostate cancer. There’s “Prostate 101,” an overview about the prostate, information about prostate cancer and getting a second opinion, and a checklist of symptoms; information on screening; treatment options; and the state of research.

This knowledge is available to patients everywhere, “irrespective of where they choose to get their medical care or where they are in terms of testing, diagnosis, or treatment,” says site editor Gretchen Gignac, a School of Medicine associate professor of hematology and medical oncology.

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Most cases of prostate cancer are slow-growing tumors that have a very high cure rate, but some cases are fast-growing.

For its founding donor, the center is as much a beacon of information to patients as an incubator for medical research. Shipley was diagnosed with prostate cancer in 2014 and chose focal laser ablation, a new and less invasive treatment than surgery and other therapies.

“The website will be unique in that it will provide up-to-date information, both on diagnostic and treatment options, in a form the layman can easily understand,” Shipley says.

Read More: http://snip.ly/olj5q#http://www.bu.edu/today/2017/shipley-center-website-offers-prostate-cancer-facts-for-patients/

Congress, keep hands off employer sponsored plans in healthcare fights

Congress, keep hands

Lawmakers are back in town and soon the Senate Health, Education, Labor and Pensions (HELP) Committee will once again take up the beast that is healthcare.

Some will be tempted to merely throw more money and the semblance of flexibility into a broken system — we urge them  to reject this Band-Aid, and to instead implement real reforms. The ERISA Industry Committee (ERIC) implores Congress not to take this opportunity to protect the employer-sponsored health insurance system, which is the single most common source of health coverage in the nation, providing 178 million Americans with access to healthcare.

Congress is focused on stabilizing endangered exchange marketplaces. ERIC heartily agrees that market stabilization is important for everyone, but addressing the cost sharing reduction (CSR) payments to insurance companies is just a small part of solving the problem.

 

Last month, ERIC, along with several other organizations, sent a letter to Congress with policy recommendations that would help stabilize the market, while also ensuring the future of affordable employer-provided health benefits.

We recommended Congress should fund CSR payments to improve affordability in the individual market. Congress should also repeal the 40 percent “Cadillac” tax on employer-sponsored health plans, with no new taxes on health benefits. And lawmakers should repeal the health insurance tax on fully insured health plans, which a recent Oliver Wyman study found will cost Americans $22 billion next year alone. They should also enable employers to innovate with Health Savings Accounts (HSAs) and protect the ability of employers to offer uniform benefits to employees and their families — no matter where they live, work, or receive medical care.

Tax relief is key to protecting the employer-sponsored system. Since World War II, the American tax code has encouraged employers to set up quality health plans for their employees by exempting company health benefit expenditures from income and payroll taxes. The Affordable Care Act placed a crippling financial burden on plan sponsors through the employer mandate and the taxes mentioned above.

An easy place to start would be fully repealing the highly unpopular Cadillac tax. It has already been delayed until 2020 and lawmakers have voted to repeal it twice. The first time in 2015 and the most recent during the healthcare votes this past July.

The Cadillac tax will hit more than 50 percent of the workforce within ten years of its implementation, according to a January study by the consulting firm Milliman —that’s 60 million Americans. These employees could see their benefits slashed by thousands of dollar while their salaries stay flat.

Some economists theorize that because of the Cadillac tax, workers might see their pre-tax wages increase as employers switch to cheaper plans. But if that happens, employees would also pay a lot more in taxes, costing 12.1 million employees upwards of $1,000 in higher payroll and income taxes.

In fact, 80 percent of the revenue raised by the Cadillac tax is expected to come from workers paying more income and payroll taxes, according to the Joint Committee on Taxation and the Congressional Budget Office.

Aside from health tax relief, another way to improve the healthcare system is updating consumer-directed health options like Health Savings Accounts (HSAs). The Committee and Congress should raise HSA contribution limits, ensuring that HSA and high-deductible plan beneficiaries have access to supplemental benefits. They should also allow consumers to use their HSAs to purchase over-the-counter medicines while updating rules to ensure those enrolled in HSA-compatible plans can benefit from first-dollar coverage for prescription drugs and other medical products and services likely to prevent or reduce catastrophic episodes in the future.

The Senate HELP Committee must also look at value-based healthcare options, which are ways plan sponsors and consumers can spend healthcare dollars smarter. Earlier this year, The ERISA Industry Committee and the Pacific Business Group on Health launched the DRIVE Health Initiative, a campaign to accelerate economic growth by controlling health costs and improving quality through the rapid adoption of value-based healthcare. The initiative calls for targeted deregulation and the use of market-based purchasing strategies by Medicare and other federal health programs.

Fixing healthcare is not easy. As lawmakers move forward in crafting new legislation, they must be sure it protects the employer-sponsored system that has provided affordable, quality coverage to more than half of the population for decades and allow for continued improvement and innovations.

If they don’t, the employer-sponsored health insurance system could be in jeopardy, creating a much bigger problem than that of the ACA exchanges.

James Gelfand is the senior vice president for health policy at The ERISA Industry Committee (ERIC). ERIC is the only national association that advocates exclusively for large employers on health, retirement and compensation public policies at the federal, state and local levels.

Management for Medical Device Industry

 

A look at these gigantic figures perhaps gives some perspective of the importance of document management for the medical device industry: The US total market for medical devices is valued at over $110 billion annually. It makes up nearly two fifths of the global market, and is expected to grow by over 20 percent by 2016.

While many global players sell into the American market, the over 6500 American medical device companies too, on their part, sell in the US and other markets.

It goes without saying that a market whose products are often complex and play a critical role in sustaining life for patients has to be highly regulated. For products sold in the American market, irrespective of whether they are manufactured domestically or overseas, a slew of regulations exist for a number of activities. Document management for the medical device industry is one of the core areas for which the FDA has regulations.

FDA and other regulations for document management for medical device industryThe FDA and other regulatory bodies have regulations and standards for GxP processes in the medical device industry. These include:

  • Quality System Regulation (QSR), which is outlined in 21 CFR Part 820, Current Good Manufacturing Practices (CGMP)
  • 21 CFR Part 11
  • ISO 13485, which relates to Quality Management System Requirements for medical devices
  • ISO 14971
  • Relevant sections of SOX, and
  • ISO 9000 standards.
What should a document management system for medical devices be like?Ideally, an electronic document management system for the medical device industry should integrate process management and document management in a simple and seamless manner. This is the real purpose of document management for the medical device industry. This document suite should be customizable and configurable. It should serve the following purposes:

  • It should help companies achieve regulatory compliance with required regulatory bodies and standards such as FDA, ISO and other regulations.
  • It should do this by automating and managing GxP processes in an efficient and cost-effective manner.
  • Communication between the functions of the company should be quick and efficient, and should allow access by designated persons.
  • Document management for medical device industry should be designed to ensure quality compliance and help companies enhance the performance of the GxP processes all through the product development lifecycle. The document management system for medical device industry should help companies have control over critical activities such as:
    • Design Control
    • Device history record
    • Mechanism for receiving and addressing complaints
    • A record of the corrective actions the company takes of these complaints
    • Note of nonconformances

Read More :  http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900830SEMINAR?wordpress_SEO

FOIA allows release of documents from the government

Description: This Act defines agency records subject to disclosure, outlines mandatory disclosure procedures and grants nine exemptions to the statute

What is FOIA?

The Freedom of Information Act (FOIA) represents the implementation of freedom of information legislation in the United States.It was signed into law by President Lyndon B. Johnson on July 4, 1966 and subsequently has been amended in 1996, 2002, 2007. This act allows for the full or partial disclosure of previously unreleased information and documents controlled by the United States Government. This Act defines agency records subject to disclosure, outlines mandatory disclosure procedures and grants nine exemptions to the statute

Background

With the stress on constitutional rights for information, it was considered important to make government information available to the public.  However since some of the information was sensitive and need not necessarily be known by the general public, this law was enacted. The belief was that the people have the ‘right to know’ about government information and could place a request for such information.

Applicability

The act explicitly applies only to executive branch government agencies. These agencies are supposed to declare the process for requesting the information or documents pertaining to the information.  This act also specifies the legal recourse in case the executive agency does not comply with the requirements of the act.

Exemptions

There are nine exemptions to the act and there are several areas of discrepancy in these exemptions. These exemptions were brought about to address the issues of sensitivity and personal rights.

Here are the exemptions

1. Executive orders kept secret in the interest of national defense or foreign policy

2.Records that are solely related to the internal personnel rules and practices of agovernment agency

3. Information that is specifically exempted from disclosure by the legislative statutes

4. Privileged or confidential commercial or financial information and trade secrets

5. Anyinter-agency or intra-agency communication in the form of memoranda or lettersthat is otherwise not available by law to any party other than the ones that are a party to litigation.

6.Files containing personnel information or medical information the disclosure of which can constitute invasion of privacy.

7. Information records compiled for the purpose of law enforcement the disclosure of which

  1. could interfere with enforcement proceedings,
  2. could constitute invasion of privacy,
  3. could disclose identity of a person, state, nation or other entities that disclose information on a confidential basis,
  4. is related to criminal law enforcement,
  5. intelligence information,
  6. information about the techniques of law enforcement the disclosure of which could support or assist in circumvention of the law and
  7. information that can endanger the life or physical safety of an individual.

8. Information related to the regulation or supervision of a financial institution.

9.Certain confidential geological and geophysical information and data including maps.

FDA 101 gives information about the agency to the public

Description: FDA 101 seeks to provide transparency about the agency and its activities to the public

FDA 101

Introduction

FDA 101 is a part of FDA, Food and Drug Administration’s transparency initiative. It was initiated to explain to the public what the agency does, in a user-friendly manner. At present public seeking information from the agency can request for the information under the Freedom of Information Act (FOIA) by submitting the request form in the process suggested by the FDA.

Transparency Task Force

As a part of this initiative a transparency task force was formed with the representatives from each of the offices of the FDA. The transparency task force collects the information that the public would like to know from the FDA, such as the regulations, how they operate, decision-making, in what circumstances enforcement actions are required, or any questions about the drug recall efforts and such other questions.

After collecting the information from the public, the transparency task force aims at preparing a FDA 101 curriculum for educating the public about the FDA and related activities.

The transparency task force hascreated a blog site where in the task force discusses the various ways information about the FDA can be shared with the public. This blog site is expected to run for a scheduled period of time, after which based on the suggestions and inputs from the public the FDA 101 will be designed. (http://fdatransparencyblog.fda.gov/?s=FDA+101)

Action points for the Transparency Task Force

  • Seek public input on transparency related issues;
  • Recommend different ways in which the agency operations, activities, processes, and decision making, can be explained ;
  • Identify information FDA should share about specific agency activities, operations,decision making,  processes, and recalls, enforcement actions, and product approvals;
  • Identify internal or external problems and barriers to providing useful and understandable information about FDA activities considering health, literacy and needs of special populations;
  • Identify tools and new technologies information sharing;
  • Recommend changes to FDA’s current operations  in order  to provide information to the public in a timely and effective manner;
  • Recommend legislative or regulatory changes;
  • Submit a written report to the Commissioner on the task force’s findings and recommendations.

The transparency task force strives to ensure that the implementation of the Task Force’s recommendations shall make FDA’s actions, decisions, and underlying processes more transparent to the public, at the same time, still meeting the agency’s goal of appropriately protecting confidential information. 

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