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June 2017 Blog Posts (28)

Understanding the way the FDA works in handling food imports

The FDA’s task is cut out when it comes to one of its core functions –that of regulating imports. With the US economy absorbing food imports to the tune of $ 49 billion every year and with its allied regulatory agencies overseeing an astronomical number of nearly half a million facilities in the US and abroad; the FDA is certainly in a most unenviable position.

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In view of the fact that these foods are imported from almost all over the world to be sold into the US…

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Added by Adam Fleming on June 30, 2017 at 5:25am — No Comments

Advantages and disadvantages of Electronic Health Records

Electronic Health Records (EHR) or electronic medical records (EMR), as they are called, are of enormous use in the fields of healthcare and medical sciences. They have a number of features that enable the patient; the medical professional and the healthcare provider have complete and unimaginably easy access to all important records that relate to the patient.

A direct result of the…

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Added by Roger Steven on June 29, 2017 at 7:50am — No Comments

Why does FDA think they can Regulate them, and why do others think they Cannot

This presentation will review the legal definition of medical device, and how it is applied by FDA to in vitro diagnostic tests. It will review the history of FDA interest in LDTs, and will describe the current situation with respect to Laboratory-developed tests. It will describe tests which have been cleared by FDA and those which have attempted clearance but not been cleared. It will discuss possible future actions by FDA and by the US laboratory community and assess their…

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Added by Adam Fleming on June 29, 2017 at 5:17am — No Comments

Safety Management and OSHA Compliance

Safety Management and OSHA Compliance 1

Why is Occupational Safety and Health Administration (OSHA) compliance necessary? For a simple reason: OSHA compliance is the surest legal way of ensuring safety at the workplace. Safety management and OSHA compliance go hand in hand and are deeply connected to and intertwined with each…

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Added by John Robinson on June 28, 2017 at 6:17am — No Comments

How current regulations effect product development strategies

The life sciences market in Japan, consisting of pharmaceuticals, medical devices, biologics and combination products, is huge by the standards of the markets in the neighborhood, such as China, Malaysia, Singapore and Australia. It compares with those of Europe and North America. The main reasons attributed for this are the high spending power of the population, high number and density of the population, the aging population and the huge spending on the healthcare sector on R and D and… Continue

Added by Adam Fleming on June 28, 2017 at 5:38am — No Comments

Documenting Software for FDA Submissions

Files

The Agile methodology is an important tool for software project management. It emerged out of the gradual efforts at arriving at a team based methodology of iterative software development. Its close association with software makes it as suitable to this field as Lean is to manufacturing.…

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Added by John Robinson on June 27, 2017 at 6:14am — No Comments

All about biosimilars –from development to registration

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Biosimilars can be described as near-copies of an original pharmaceutical product that another company may have manufactured. These products are versions of an original or innovative product, but are officially approved.

There is a misconception that they are similar to or are the same as generics, but this is not so in…

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Added by John Robinson on June 27, 2017 at 6:01am — No Comments

Putting the MS Excel VBA to optimal use

Visual BASIC for Applications (VBA) is the programming language built into MS Excel and other MS programs. It is a macro, which, as we know, is a recording of a series of tasks. At a simple level, it can be thought of as a smaller version of programing in that once certain tasks are assigned to it, it carries them out.

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The main function of a macro is to work within a program such as MS Excel and automate tasks that…

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Added by Adam Fleming on June 27, 2017 at 5:36am — No Comments

Food Manufacturing Sanitation Checklist

This was created by Meyer Industrial

Added by Meyer Industrial on June 22, 2017 at 5:11pm — No Comments

10 Ways To Destress Your Employees (Infographic)

The Jacobson Group created the infographic below to showcase easy steps to help relieve stress for your employees during the work day. A more stress free environment can help build a stronger relationship with your employees as well as a more efficient and productive workplace. Check out some of our tips below!…

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Added by The Jacobson Group on June 21, 2017 at 12:00pm — 1 Comment

Guide to Comparing Safety Gloves

Something that fits perfectly is said to fit “like a glove,” but those who work with hazardous materials should know that, depending on the circumstances, a glove may not fit “like a glove” at all. That’s because not all gloves provide the same level of protection against all types of hazardous materials. What provides complete protection against certain types of chemical solvents may not protect you from other types. Whether you work in a laboratory or in an industrial environment where…

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Added by Enviro Tech International on June 20, 2017 at 11:05am — No Comments

HIPAA compliance expectations from Small Healthcare Providers

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Added by John Robinson on June 14, 2017 at 6:27am — No Comments

Food safety concerns and issues and ways of mitigating them

Food, despite being the most important human need, is fraught with many risks and hazards. The food chain, which consists of activities that cover everything from the proverbial farm to fork, passes through many points at which a harm of any nature can happen. The chances of risks to the food safety chain are all the more amplified in this age of globalization, when food travels through many regions and continents from its source to its destination.…

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Added by Adam Fleming on June 14, 2017 at 6:09am — No Comments

A Guide to Employee Recognition

Employees are a company’s most valuable asset, and should be recognized for all the work they do for a company. Motivating them to go above and beyond is extremely important for a successful business, and recognizing employees is a great way to increase productivity and improve workforce engagement and retention. Many employers use employee recognition programs to improve safety amongst workers. In honor of National Safety Month, here is an infogrpahic on how to implement an incentive…

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Added by Julie Feece on June 13, 2017 at 10:47am — No Comments

Bringing about positive changes into the US healthcare system

The American healthcare industry is a curious mélange. On the one hand, it is the world’s largest industry, with an estimated size of around $ three trillion. It is a system in which any treatment option that one can think of is available to the patient. Yet, it is characterized by a high degree of inefficiency and exorbitant costs. Many treatment options are out of reach of a large number of patients. It also suffers from non-implementation of many best practices that would have ensured a…

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Added by Roger Steven on June 13, 2017 at 8:24am — No Comments

Change Control is at the core of GMP Compliance

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Added by John Robinson on June 13, 2017 at 6:46am — No Comments

HIPAA implementation for human resources

It is not commonly known that a Covered Entity or its Business Associate have to comply with HIPAA regulations that relate to their organization’s human resources function. While HIPAA requirements for departments that deal with IT security and risk management are commonly known; HIPAA for the human resources department is also important.

HIPAA lays down a number of requirements that the HR…

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Added by Roger Steven on June 12, 2017 at 8:40am — No Comments

Safety Tips for Amateur and Professional Gardeners

Gardening is an excellent way to get physically fit and if you’re a professional landscape gardener or outdoor handyman, it’s also a lovely way to earn a living. But there are a number of safety risks to consider, and, whether you’re an amateur flower…

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Added by Alex on June 12, 2017 at 6:57am — No Comments

Learn how to build professional, eye-catching form-driven applications and spreadsheets

MS Excel, a wonder program, has umpteen uses for a number of professionals, students, and a host of other users. We have known for long that it can be used to carry out a number of functions that are varied and interesting. However, adding design elements to MS Excel goes a long way in enhancing its aesthetic appeal, as also the effectiveness.

Booking forms, sales order forms, invoices, loan agreement forms and surveys are just some of the endless kinds of forms…

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Added by Adam Fleming on June 12, 2017 at 5:52am — No Comments

An effective internal audit program is indispensable for continuous improvement

Both the ISO and the FDA require an internal audit program of an organization’s Quality Management Systems. This is a core requirement. The simplest way to understand an internal audit system is that it is a tool to assess or inspect an organization’s Quality System.

Apart from helping organizations to fulfill the requirements of auditing set out by the ISO and the FDA…

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Added by Adam Fleming on June 9, 2017 at 6:31am — No Comments

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Wow Gold

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Outlook PST Recover 2 Replies

If your outlook data corrupted which is a part of the Ms Office Suit commonly use as an email application. It includes some email items like calendar, tasks, contact and other items. You may use any…Continue

Tags: outlook, recover, recovery, pst

Started by colin munro. Last reply by treykelly 20 hours ago.

eSoftTools NSF to PST Converter 1 Reply

Here I am prescribing eSoftTools NSF to PST Converter programming that safely performs to recover NSF…Continue

Started by Irisrose. Last reply by treykelly 21 hours ago.

How to convert NSF data files to Outlook PST 7 Replies

If you want to convert the NSF data to Outlook PST and other formats. If you want to follow the 2 way, definitely you can convert all NSF data to PST. The first method is Manual.Manual method is free…Continue

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Started by Max Beckham. Last reply by treykelly 21 hours ago.

Zip password recovery

Recover zip file password with the help of the eSoftTools zip password recovery software instantly.…Continue

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How EDB to PST Converter software important for Exchange user? 2 Replies

Do you know how Exchange server is important for Exchange user? You get know by reading this articleThis article will give you the brief idea of how…Continue

Started by Rose Watt. Last reply by jan smith yesterday.

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