Adam Fleming's Blog (255)

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.

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…

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…

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.

GLP’s are Quality…

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 3^rd edition,…

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…

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.…

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.…

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,…

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…

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.

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

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…

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.

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