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September 2017 Blog Posts (60)

How to Reduce Compliance Risk? Join Now: Trainings at $10

As a regulatory professional, do you face the same jitters as thousands of your peers in the industry? Are you concerned, like many of them, about how to reduce compliance risk? Then, join now: trainings at $10!

How to reduce compliance risk is a major challenge for regulatory professionals. Whether they are experienced or are new, there is some discomfort in implementing the…

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Added by John Robinson on September 21, 2017 at 7:16am — No Comments

RPS says pharmacists must always be present in pharmacies

The three RPS national boards have jointly called for legal guarantees that a pharmacist will always undertake a clinical assessment or check, and that there must be no legal loopholes that can bypass this requirement.

www.pharmaceutical-journal.com/Pictures/580xAny/0/2/3/1074023_pharmacy-counter-patient-pharmacist-al-17.png"…

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Added by John Robinson on September 21, 2017 at 6:05am — No Comments

FDA Warns on Mixing Opioid Addiction Treatments, Other Meds

TRENTON, N.J. (AP) — The Food and Drug Administration issued new warnings Wednesday about the dangers of combining medication for opioid addiction with anti-anxiety medicines and other drugs that also slow breathing and brain activity.

The FDA warned that mixing such drugs can cause difficulty breathing, coma or death, so it should be done with caution.

The agency said…

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Added by Adam Fleming on September 21, 2017 at 6:04am — No Comments

Brain Activity and Good Diet May Prevent Insomnia-Related Depression

Brain Activity and Good Diet May Prevent Insomnia-Related Depression
While lack of sleep is a major risk factor for depression, not everyone who tosses and turns at night becomes depressed. According to a study, individuals whose brains are more attuned to rewards may be protected from the negative mental health effects of poor sleep. The findings revealed that students with poor quality sleep were less likely to…
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Added by John Robinson on September 21, 2017 at 6:02am — No Comments

FDA Finalizes Guidance on Interoperable Medical Devices

On September 6, 2017, FDA finalized a guidance document entitled “Design Considerations and Pre-Market Submission Recommendations for Interoperable Medical Devices” (“Final Guidance”). In the Final Guidance, the agency outlines design considerations for manufacturers when developing…

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Added by John Robinson on September 20, 2017 at 6:32am — No Comments

Graham-Cassidy health care bill: What you need to know

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Sens. Lindsey Graham of South Carolina and Bill Cassidy of Louisiana have drafted the latest Republican attempt to repeal Obamacare. The bill would overhaul or eliminate major sections of the health care law, including its subsidized insurance coverage and Medicaid expansion. Instead, states would receive block grants, or a lump sum of money from the federal…

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Added by John Robinson on September 20, 2017 at 6:29am — No Comments

Q7 and Other Requirements for Active Pharmaceutical Ingredient (ASM) GMP

In late 2016, the FDA published the revised the Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, Guidance for Industry. The aim of this revision is to address Good Manufacturing Practices (GMPs) for a Quality Management System for Active Pharmaceutical Ingredients (API’s). Another of its aims is to help companies ensure that they meet the requirements of API quality and purity characteristics. While replacing Q7A Good Manufacturing Practice…

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Added by Adam Fleming on September 20, 2017 at 6:27am — No Comments

Nitinol-based Medical Devices 2017 Global Market Expected to Grow at CAGR 10.50 % and Forecast to 2021

About Nitinol-based Medical Devices

Nitinol-based medical devices are made of nitinol, an alloy of nickel and titanium. The use of nitinol-based stents and guidewires has improved procedural outcome. The nitinol alloys are corrosion resistant and are highly accepted in the medical device industry. The global medical devices market has been growing extensively over the years. With increasing investment in research and development (R&D) for manufacturing…

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Added by Adam Fleming on September 19, 2017 at 6:05am — No Comments

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…

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Added by John Robinson on September 19, 2017 at 5:54am — No Comments

Hermetic Packaging, Connectors for Medical Implant Industry

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Hermetic Implantable Packaging and Connectors for Medical Components

PA&E works with leading medical implant designers to advance integration and performance for hermetic implantable packaging and connectors in one of the most unique and critical environments known: the human body.

PA&E has created proprietary materials and encapsulations with hermetic seals that enable implantable medical…

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Added by John Robinson on September 19, 2017 at 5:51am — No Comments

Pharmacist in deadly meningitis outbreak heading to trial

Teens also at risk for orga

And the damage to the heart and blood vessels can occur in youth at blood pressure levels that are below the clinical definition of hypertension in youth.

High blood pressure in youth is defined differently than it is in adults. In childhood, high blood pressure is based on percentiles, rather than blood pressure level. Researchers looked at…

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Added by John Robinson on September 18, 2017 at 7:45am — No Comments

Pharmacist in deadly meningitis outbreak heading to trial

Pharmacist in deadl

After watching his mother die from meningitis in a nationwide outbreak caused by contaminated steroids, Scott Shaw is determined to make sure something like that never happens again.

A stiff punishment for the Massachusetts pharmacist Shaw believes is partially responsible…

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Added by John Robinson on September 18, 2017 at 7:42am — No Comments

How to Get a Job in Compliance with no Experience? Learn New Skills for $10

For people on a job hunt, the reason for not offering one is almost invariably the same: You lack experience. How do you convince the organization that one can gain no experience unless one has a job? This is a typical chicken and egg conundrum: You are not given a job because you have no experience, and you have no  experience because you don't get a…

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Added by Roger Steven on September 18, 2017 at 6:52am — No Comments

A common technique plots the data to help detect trends, cycles, and shifts

Some of the functions of medical device manufacturers include:

o  Analyzing complaints

o  Processing data

o  Evaluating nonconformances

o  Utilizing other quality data sources.

The main purpose of this analysis, done using appropriate statistical methodology, under §820.100, is to identify the cause of nonconforming products and other quality problems. Time series analysis is one such family of these tools. Also called trending analysis,…

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Added by Adam Fleming on September 18, 2017 at 6:49am — No Comments

Hurricane Harvey HIPAA Reminder

Disasters, which can ultimately lead to a data breach, come in various forms – natural, man-made and technical. HIPAA, the HITECH Act, the Federal Trade Commission and the Securities and Exchange Commission are just a handful of entities requiring that the confidentiality, integrity and availability of the sensitive information (e.g., protected health information (PHI) and personally identifiable information (PII)) remain intact. Although federal HIPAA has distinct…

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Added by John Robinson on September 15, 2017 at 6:46am — No Comments

The job of the corporate controller –prospects and pitfalls

The job of the corporate controller –prospects and pitfalls3

The position of the corporate controller, or company controller, has become an important one in companies today. This is a role that has come into being following the evolution of the corporate setup, which has brought with it many changes. The corporate controller has come into existence because of these changes.

In simple terms, the corporate controller is one who can be defined as the chief accounting officer. She is to accounting what the chief…

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Added by John Robinson on September 15, 2017 at 6:43am — No Comments

Are you considering a career in compliance? Join our $10 Training Online

What, in your estimate, is the cost of taking up a career in compliance? Thousands of dollars? Hundreds? Well, none of these! If you are considering a career in compliance, join our $10 training online! Yes, $10 is all that it costs for you to start a career in compliance!

Who is offering this monstrous offer, and why? Let us explore this a bit for you: GlobalCompliancePanel, a leading provider of professional trainings for all the areas of regulatory compliance, has come up with an…

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Added by John Robinson on September 15, 2017 at 6:06am — No Comments

Are You Obese but Healthy? You May Still Be 96% More Susceptible to Heart Failure

Are You Obese but Healthy Obesity is one of the biggest causes of non-communicable, lifestyle diseases today. According to the World Health Organisation, close to 1.9 billion adults were obese in the year 2014. Around 2.8 million people die due to some complications associated with obesity every year. A recent study published in the Journal of the American College of Cardiology notes that obese people who may otherwise be healthy and free from ailments like diabetes, hypertension, et cetera may still run at…

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Added by John Robinson on September 13, 2017 at 6:45am — No Comments

Progress on global poverty and disease at risk, Gates says

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LONDON, Sept 13 (REUTERS) – Proposed United States budget cuts could put in jeopardy great progress in reducing global poverty and disease and lead to 5 million more deaths from AIDS alone, the philanthropist Bill Gates warned on Wednesday.

Gates, whose Bill and Melinda Gates…

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Added by John Robinson on September 13, 2017 at 6:38am — No Comments

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