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Adam Fleming's Blog (75)

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 6:08am — No Comments

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 5:26am — 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 5:46am — 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 5:26am — No Comments

Understanding GLP's and their relationship with GMPs and SOP’s

Good Laboratory Practices (GLP’s) are a series of federal regulations passed in the US by the FDA under 21 CFR Part 58. In addition, Environmental Protection Agency (EPA) also has formed GLP’s both for Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) in 40 CFR Part 160 and for Toxic Substances Control Act (TSCA) in 40 CFR Part 792.

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GLP’s are Quality…

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Added by Adam Fleming on July 17, 2017 at 5:37am — No Comments

Steps to IEC 60601-1 approval

The 60601-1 is a standard that relates to the safety of medical electrical equipment. This harmonized standard is recognized by most countries around the world. Existing and new medical devices have to comply with the requirements set out in IEC 60601-1.

The IEC 60601-1 is going through its latest revision, its 3rd edition,…

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Added by Adam Fleming on July 14, 2017 at 6:26am — No Comments

How to control those risks and monitor the effectiveness of the controls put in place

Overview of this session 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, and how to create processes and procedures to implement them.

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…

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Added by Adam Fleming on July 13, 2017 at 5:42am — No Comments

Uniform Customs and Practice standard and can be negotiated by over 30,000 banks worldwide

Letters of Credit are the primary instruments for assuring payment of goods sold internationally. This web session is designed to provide attendees with an end-to-end understanding of the L/C (letter of credit) process. From the beginning of a contractual agreement, through the letter of credit application process and actual negotiation of the L/C, this information-rich webinar will provide techniques that are indispensable to both importers and exporters.…

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Added by Adam Fleming on July 12, 2017 at 5:23am — No Comments

How to deal with dynamic source data and the “refresh” concept

Microsoft Excel comes with a myriad of tools such as sorting, filtering, and subtotal to manage large lists of data. Yet, when it comes to analyzing all that data and doing it quickly, the MS Excel PivotTable is a very useful feature. It is particularly important and useful when the user is required to quickly create a compact summary report (based on lots of data) without needing to write complex formulas or rely on lengthy techniques.…

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Added by Adam Fleming on July 11, 2017 at 5:39am — No Comments

Guarding against cyberattacks

Data breaches, malware and related frauds can cost an organization very dearly. The effects of cyber fraud are rather alarming:

It was estimated that cyberattacks amounted to a loss of at least a trillion dollars to the US economy in 2013, up by more than 25% over the previous year. The US continues to be the largest target and sufferer of cyberattacks. It accounts for more than a third of all cyberattacks that happen all around the world, followed by India, which is a distant second,…

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Added by Adam Fleming on July 10, 2017 at 5:19am — No Comments

Understanding and dealing with Automated Clearinghouses (ACH) frauds

Automated Clearinghouses (ACH) are a popular means of financial transactions, as they substitute actual physical paper documents such as cards and checks. ACH’s are an electronic network that facilitate and carry out a huge number of transactions online. In being online and quick; they have grown as a byproduct of the IT revolution and have gained popularity around the world for the ease of payments they…

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Added by Adam Fleming on July 7, 2017 at 5:33am — No Comments

One of the technique described in ISO 14971 is Hazard Analysis

The confusing terms”hazard”, hazardous situation”,”harm”,”causative event”,”ALARP”,”risk index”,”residual risk” will be explained. We will go step by step through a template for hazard analysis so that the process is clear. Examples of hazards and hazardous situations will be discussed. How to deal with residual risk will be discussed. We will go step by step through a typical hazard analysis. We will explain how to integrate Human Factors studies into the Hazard Analysis and how to…

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Added by Adam Fleming on July 6, 2017 at 6:00am — No Comments

Mastering budget spreadsheets in MS Excel

Cash flow budgets, preserving key formulae and streamlining formula writing are just some of the varied functions of MS Excel. This wonder program helps the user to carry out a number of functions, all of which help in facilitating business decision-making. These apart; MS Excel offers users the opportunity to explore and carry out a vast range of activities, functions and calculations.

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An expert with a quarter of a century of working in the world of Microsoft…

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Added by Adam Fleming on July 3, 2017 at 5:20am — No Comments

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 5:34am — 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

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…

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Added by Adam Fleming on June 28, 2017 at 5:39am — 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 6:07am — No Comments

Maximizing profits and patient outcomes in the backdrop of declining reimbursements

In the situation of falling revenues from Medicare billing, many practitioners are worried about the state of their future earnings. A very tangible factor that will help them tide over this problem is often overlooked: the Durable Medical Equipment (DME) program.

The DME program is a very reliable and long term source of income for Medicare practitioners. Yet, this is not considered seriously by most of them because of the various misconceptions that are associated…

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Added by Adam Fleming on June 13, 2017 at 5:44am — 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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