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July 2017 Blog Posts (62)

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

Managing Workflows Requires Quite an Ability

Managing workflows is a serious talent. Managers and many other employees are required to handle umpteen tasks, all of which need to be completed at more or less the same time. When tasks are scheduleding tightly, most of the doer’s attention is concentrated purely on getting the job done. This is no doubt important, but most people do not plan for a contingency.

Whenever jobs or tasks are lined up in close…

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Added by kate smith on July 31, 2017 at 6:03am — 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 Fleaming 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…

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Added by Adam Fleaming 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…

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Added by Adam Fleaming 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

Meetings Have to be Effective if They Have to Serve Their Purpose

Meetings, meetings and meetings. Many organizations seem to have unlimited numbers of meetings all day, to such an effect that meetings have more often than not become the butt of office ridicule. Many jokes about the total waste of time that meetings do the rounds. Sample a few of them:

We will continue having lots of meetings until we find out why no work is getting done.

Lonely? Don’t like your work? Then call for a meeting. You can see people drawing pictures and…

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Added by kate smith on July 28, 2017 at 5:00am — No Comments

Onboarding New Hires is a Skill

Onboarding starts with the induction of the new hires. It includes their acclimatization with all the important aspects of the new organization, such as the business, the organizational culture, the people, and the environment. Since onboarding is such an important activity; it is not right to think that it is just yet another of the many tasks that HR does. It goes a lot more beyond paperwork and…

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Added by kate smith on July 27, 2017 at 6:07am — 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

An Explanation of the D.I.S.C. Personality Assessment

A 100-employee business spends an average downtime of 17 hours a week on just clarifying communications. In the process, it ends up losing over half a million dollars annually on this exercise. The reason: Lack of effective communication. This is at the heart of the problems that most organizations face. About 70% of small to mid-size businesses admit that communication is their primary problem.   

The cost…

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Added by kate smith on July 26, 2017 at 7:36am — No Comments

Quality Assurance Auditing for FDA-regulated industries

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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

The centrality of Risk Analysis to HIPAA

Carrying out audits is among the most important requirements for any organization that handles Protected Health Information (PHI). HIPAA hosting providers, who implement safeguards in the manner specified in the HIPAA Privacy…

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Added by Roger Steven on July 25, 2017 at 8:00am — No Comments

Guarding Against Corporate Scamming

Getting emails announcing that you have been selected as a winner of an online lottery from a distinguished company and will be winning millions of dollars is an almost quotidian occurrence. While the fact that people do send out such mails in this age is surprising; what is even more surprising is that many…

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Added by kate smith on July 25, 2017 at 7:09am — 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 Fleaming on July 25, 2017 at 5:31am — No Comments

Understanding the Importance of Drafting the Employee Handbook Rightly

Employee handbooks are a great way for organizations to state their policies vis-à-vis employee behavior. On the one hand, they are a simple and reliable guide to letting employees and other people connected to the organization in one or another way about many aspects of the organization’s…

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Added by kate smith on July 24, 2017 at 6:58am — 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 Fleaming 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

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Training Doyens posted an event
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The Role of Internal Audit in CECL Compliance at 26468 E Walker Dr, Aurora, Colorado 80016-6104

December 14, 2017 from 1pm to 2pm
OVERVIEWThe best ways to leverage an internal audit department as the organization becomes CECL compliant are explained in this session. Participants will learn what IA can or cannot do and how the internal auditors can assist in ensuring that CECL processes are robust and complaint with regulator expectations.With all the attention placed on CECL, it is important that organizations utilize all resources available to them. Also, Internal Audit is in a unique position to help the organization…See More
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Training Doyens updated an event
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Presentation Skills for IT Professionals at 26468 E Walker Dr, Aurora, Colorado 80016-6104

December 14, 2017 from 1pm to 2pm
OVERVIEWOn successful completion of this course you will be able to:Develop and organize engaging presentationsUse your voice and other physical skills to project confidence enthusiasmDesign and use appropriate visual aidsHandle questions from an audience with easeHow to make your presentation clear and accessible,How to interact with your audienceHow to retain their interest while keeping your anxiety under control.The ability to present articulately to management, to customer or to a non tech…See More
4 hours ago
John Robinson posted a blog post

Regulations in the US and EU Dealing with Combination Products

Registering and maintaining combination products in the US and the EU is a bit tricky, because these are disparate markets that are governed by different sets of regulations which are independent of each other. So, any business that wants to market combination products into the US or the EU must be completely aware of the nature and meaning of all the regulations. Such businesses…See More
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Occupational Health and Safety 5 Replies

Health and safety are important aspects of an organisation’s smooth and effective functioning.  Did you know that workplace health & safety injuries cost Australian businesses over $60 billion…Continue

Tags: Safety, and, Health, Occupational

Started by WHS Solutions. Last reply by Tara safe on Thursday.

QlikView for its Safety Strategic Business Intelligence Solution Worldwide

QlikTech (NASDAQ:QLIK), a leading…Continue

Tags: Qlikview, safety

Started by nicolewells on Wednesday.

What's your favorite motivational/safety quote? 102 Replies

Favorite Motivational Quote: If you want something, you'll find a way - If not, you'll find an excuse.Favorite Safety Quote: Don't learn safety by accident!Continue

Started by Michelle Sears. Last reply by David Collins on Tuesday.

Business Intelligence with Big Data happens at Unipê

the college center of João Pessoa will preserve the 1st assembly at big records, geared toward professionals inside the regions of administration, economics, public control and facts technologies.…Continue

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Started by Soujanya Naganuri Nov 1.

Road Safety Solutions 13 Replies

The Road Safety Signs ,Barriers,Humps,Hazard Markers and Visual Warnings are some of the important marks to be observed. Signs such as "keep left",stop, "give way" should not be casually treated.…Continue

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