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July 2017 Blog Posts (38)

Effective legal writing skills are essential for FDA submissions

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A number of reasons make cultivation of the art of effective legal writing skills for FDA submissions important. Documents that are submitted to the FDA…

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Added by John Robinson on July 31, 2017 at 6:27am — No Comments

Ways of getting the PREDICT, ACE and the HTS right to smoothen shipping

In September 2014, the FDA deployed a new risk-based screening tool for imports called the Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT). The main aim of PREDICT was bringing about improvement in screening and targeting of adulterated or misbranded goods or those that flout any of the FDA’s rules. The FDA seeks to bring this about by doing away with its legacy electronic system, OASIS’ admissibility screening function.

PREDICT is an important tool…

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Added by Adam Fleming on July 31, 2017 at 5:27am — No Comments

Ways of getting the PREDICT, ACE and the HTS right to smoothen shipping

In September 2014, the FDA deployed a new risk-based screening tool for imports called the Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT). The main aim of PREDICT was bringing about improvement in screening and targeting of adulterated or misbranded goods or those that flout any of the FDA’s rules. The FDA seeks to bring this about by doing away with its legacy electronic system, OASIS’ admissibility screening function.

PREDICT is an important tool…

Continue

Added by Adam Fleming on July 31, 2017 at 5:27am — No Comments

Ways of getting the PREDICT, ACE and the HTS right to smoothen shipping

In September 2014, the FDA deployed a new risk-based screening tool for imports called the Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT). The main aim of PREDICT was bringing about improvement in screening and targeting of adulterated or misbranded goods or those that flout any of the FDA’s rules. The FDA seeks to bring this about by doing away with its legacy electronic system, OASIS’ admissibility screening function.

PREDICT is an important tool…

Continue

Added by Adam Fleming on July 31, 2017 at 5:27am — No Comments

Vital Stark Law considerations for physician employment agreements

Since the Affordable Care Act (ACA) –popularly called Obamacare –came into existence, there has been an exponential increase in the number of physician practice acquisitions. Some of the reasons that can be ascribed for this phenomenon are these:

-        Physician practice…

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Added by Roger Steven on July 28, 2017 at 7:32am — No Comments

Social Media Do's And Don'ts

Stevenson University Online offers a wide range of graduate and professional study options.

Added by Stevenson University on July 26, 2017 at 8:30am — No Comments

Quality Assurance Auditing for FDA-regulated industries

Quality Assurance Auditing for FDA-regulated industries5

An effective audit constitutes the heart of an effective Quality System. The FDA and other regulatory agencies have emphasized this principle time and again. The purpose of an audit program is to ensure proper and thorough compliance with the guidelines set out by the regulatory agencies. A…

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Added by John Robinson on July 26, 2017 at 5:51am — No Comments

Don't Fall Asleep At Work With These Tips

Does your job keep you awake at night? If so, you’re not alone. Nearly half of American workers say job-related anxiety keeps them from falling asleep.

That lack of sleep can lead to a vicious cycle: You’re stressed about work, which means you can’t sleep, which leads to lower productivity at work, which means you’re stressed about work, which means you can’t sleep, etc. Getting the seven to nine hours of uninterrupted sleep that we need isn’t just a good idea, it could be the key to…

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Added by Erin Orr on July 25, 2017 at 3:30pm — No Comments

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…

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Added by John Robinson on July 25, 2017 at 6:14am — No Comments

Understanding and applying ICH Q3A and Q3B

The ICH Q3A and Q3B are guidances on dealing with impurities in new drug products. These documents have been issued by the FDA and are updates of earlier versions on the same topic that were prepared by the ICH, which this FDA guideline complements. This is why the documents get their name. The FDA keeps revising these documents from time to time. After every revision, the latest version carries the added taxonomy of “R” to denote that the guidance is a revised one.…

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Added by Adam Fleming on July 25, 2017 at 5:31am — No Comments

Implementing ICH guidelines-compliant validation

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Professionals in the field of statistical analysis need to possess clarity on understanding and interpreting statistical concepts used to investigate quantitative ICH Guidelines, such as:

  • Analytical methods validation
  • Procedures and acceptance criteria in calibration limits…
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Added by John Robinson on July 24, 2017 at 6:06am — No Comments

How to Comply and how to Protect Privacy

The General Data Protection Regulation (GDPR) –codified as Regulation (EU) 2016/679 – is an important law concerning the protection of data of all people living in the European Union (EU). Through the GDPR regulation; all the legislative and secretarial bodies of the EU, namely the European Parliament, the Council of the European Union and the European Commission, fortify and toughen and unify all aspects of…

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Added by Adam Fleming on July 24, 2017 at 5:16am — No Comments

Michigan Safety Conference Elects New Board Chair

EAST LANSING, MIJuly 21, 2017 – The Michigan Safety Conference (MSC), announces that AJ Hale, Safety & Loss Prevention Manager, CompOne Administrators, has been elected Chairman of the Board of the Michigan Safety Conference, for a three-year term.  Hale is a Senior Board Member, Past President, Past Distinguished Service Award Winner, and was a member 2013-2014 Bylaws Review Committee. He currently serves on the Arrangements Committee, Site…

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Added by Denise McGinn, CAE on July 21, 2017 at 3:52pm — No Comments

Sources of contamination that exist in a clean room environment

Aseptic technique is one of the methods used in eliminating or at least minimizing contamination in pathogens. It is also used to make compounding sterile products. Sterilized equipment, sterile apparel, high degree of processing, and cleaning on a continuous basis make up the important procedures used in aseptic technique.

The main aim of aseptic technique in cleanrooms is to ensure that the sterile product is sterile, safe and effective. Ensuring this is all the more important for…

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Added by Adam Fleming on July 21, 2017 at 6:07am — No Comments

An integrated approach is needed for Complaints Handling, Adverse Event Reporting, and Recalls

Adverse Event Reporting, and Recalls4

The fact that medical device manufacturers work and operate in various regulatory systems whose requirements are different and not always consistent with each other is recognized and empathized by the…

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Added by John Robinson on July 21, 2017 at 5:54am — 1 Comment

Understanding opportunities in NAFTA

The North American Free Trade Agreement (NAFTA) came into being on the first day of 1994. While the US and Canada had been having free trade agreements that go back at least three decades culminating in the US-Canada Free Trade Agreement of January 1, 1989; NAFTA became a reality following Canada’s entry in 1991 into the bilateral talks between the US and Mexico, creating the trilateral FTA.

One of the primary objectives of the NAFTA was the elimination of a number of duties and…

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Added by Adam Fleming on July 20, 2017 at 5:24am — No Comments

Training and Development is a highly developed and evolved, broad body of knowledge. Many employees place themselves at a disadvantage vis-à-vis their colleagues in the absence of the right professio…

Development of technical training in the life sciences3

Training and Development is a highly developed and evolved, broad body of knowledge. Many employees place themselves at a disadvantage vis-à-vis their colleagues in the absence of the right professional training and development. If employees have to consistently close gaps in their learning, they need to keep…

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Added by John Robinson on July 19, 2017 at 6:21am — No Comments

How to create processes and procedures to implement them?

Product Risk Management is a critical aspect of ensuring medical devices are safe and effective for intended uses. This course will help you understand the regulatory requirements, including ISO14971.

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You’ll learn techniques that can help you identify hazards and potential harms. You’ll learn how to mitigate risk and effectively monitor risk to ensure your customers receive safe and effective products. A rigorous…

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Added by Adam Fleming on July 19, 2017 at 5:45am — No Comments

Ensuring compensation-focused compliance with Stark Law considerations

Stark Law compliance is now more than just a compliance issue. It has grown to become an Enterprise Risk Management matter, if the substantial awards and settlements in recent enforcement actions are anything to go by. For healthcare organizations that develop and implement provider contracts; managing their…

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Added by Roger Steven on July 18, 2017 at 7:52am — No Comments

Why is credit card surcharge an issue for businesses?

The credit card surcharge issue has always been a tricky one in the US. Back in 2005, this issue was the subject of an antitrust lawsuit, and the resultant judgment, which came in mid-2012 prohibited credit card surcharge in ten States. Another 12 States are in the process of implementing their laws.

Although credit card regulations have traditionally opposed surcharging; companies have been circumventing merchant rules to ensure that credit card surcharge continues to be made. Even…

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Added by Adam Fleming on July 18, 2017 at 5:25am — No Comments

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Fire Protection safety Tips for Schools

While the number of school fires has decreased over recent years, they continue to be a serious risk for schools. Every year around one in twenty schools experiences a fire and nearly hour of faculty fires are started deliberately.The short effects of loss of facilities and instrumentation may be calculated, however the longer-term effects of loss of work, disruption of…See More
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Pro-Sapien Software posted a blog post

Pro-Sapien partners with LMS365 to offer integrated Learning Management on Office 365

Pro-Sapien Software, specialist providers of EHS software on Office 365, has announced its partnership with fellow Microsoft ISV ELEARNINGFORCE International to offer Training Management alongside Pro-Sapien’s HSEQ Innovate.ELEARNINGFORCE’s product LMS365 empowers people through learning management fit for the Modern Digital Workplace. Managers can create, distribute, and track learning courses; employees can manage their own learning schedule with progress trackers, notifications and…See More
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AI Machine Learning In Businesses How wоuld уоu define a small buѕinеѕѕ, thе number оf реrѕоnеl, thе size оf the budget, оr ѕаlеѕ?

How wоuld уоu define a small buѕinеѕѕ, thе number оf реrѕоnеl, thе size оf the budget, оr ѕаlеѕ?However you define уоur оwn ѕmаll business, it tоо can tаkе advantage оf thе AI/ …Continue

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Started by emmablisa on Monday.

Distracted Driving 1 Reply

****WARNING**** Despite the fact that this is a life event portrayed by actors, it's graphic. This video should be part of…Continue

Tags: texting, fatality, safety, car, driving

Started by Wendy. Last reply by Jen McDade Dec 5.

Safety update: OSHA announces fit-test procedures 1 Reply

Fabricators as well as other workers may be required to use respirators to protect themselves from inhaling fumes, particles, or dust when performing cutting, grinding, welding, coating, or painting,…Continue

Tags: online, training, Safety, workplace, PPE

Started by Safety Training International. Last reply by Jen McDade Dec 4.

Proper guarding protects workers: Six steps to focusing on your employees' needs 1 Reply

When people think of machine guarding, usually they think of devices to protect people from the moving parts on machinery.When people think of machine guarding, usually they think of devices to…Continue

Tags: training, compliance, PPE, Training, Safety

Started by Safety Training International. Last reply by Jen McDade Dec 4.

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