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Adam Fleming's Blog (255)

Learn How to manage and improve Human reliability

Manufacturing is a behemoth of an activity that straddles several industries. Modern manufacturing has come a long way from the days of its infancy, which can be traced to the Industrial Revolution of some 250 years ago. Getting advanced and refined at many stages; production or industrialization or manufacturing is the lifeblood of most of the world’s economies. Automation in the processes may have been introduced in many industries; yet, manufacturing…

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Added by Adam Fleming on October 24, 2017 at 6:20am — No Comments

What is cyber security certification worth?

There have been a lot of interesting reactions to the Equifax data breach. One of the most interesting for me is the criticism of the Equifax CISO’s lack of technical or cyber security education. She does have Bachelor’s and Master’s degrees in music composition as well as a resume that shows a work history at several companies also in the finance industry. This situation illustrates the challenge we all face in identifying qualified candidates.…

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Added by Adam Fleming on October 23, 2017 at 6:32am — No Comments

Learn How to Prevent Quality and Compliance Problems by having a strong system for Purchasing Controls!

In this era of globalization; outsourcing has become a major component of business. Outsourcing brings many benefits for companies. Short and long-term cost benefits, the ability to concentrate on their core activities and grow their business, and the freedom of avoiding the actual tasks that go into manufacturing are some of the stated…

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Added by Adam Fleming on October 19, 2017 at 6:20am — No Comments

Ukraine Will Pursue Hard Reforms This Fall, Finance Minister Says

After a week of back-to-back meetings in Washington, Oleksandr Danylyuk is tired. He gladly downs a cup of coffee before we turn on our microphones to discuss Ukraine’s economy. The affable forty-two-year old finance minister is one of the few reformers left in Ukraine’s Cabinet of Ministers and has a reputation as a doer. He’s in town for the International Monetary Fund’s and World Bank’s annual meetings.…

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Added by Adam Fleming on October 18, 2017 at 5:35am — No Comments

When SSARS does and does not Apply to Preparation Engagements

The Statement on Standards for Accounting and Review Services (SSARS) is a section of the professional standards set out by The American Institute of CPA’s (AICPA), seeking to review earlier standards for reviewing and compiling financial statements and setting out the terms of engagement between the…

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Added by Adam Fleming on October 17, 2017 at 6:23am — No Comments

Who Benefits from the changes, and How it will affect the Retailers and Customers

Credit card surcharge was the bone of contention in an antitrust lawsuit filed 2005. As a result, the judgment in this case, which came in mid-2012, prohibited credit card surcharge in ten States. The implementation of their respective laws is underway in another 12 States.

Credit card regulations have traditionally opposed surcharging. Yet, companies have been devising ways by which they have sidestepped merchant rules and have continued to ensure that credit card surcharge gets…

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Added by Adam Fleming on October 16, 2017 at 6:13am — No Comments

How to test your firm's Compliance Program based on what the Regulators are Focusing on

The financial regulators publish a listing of their exam initiatives for the upcoming year. Financial advisers use this listing to anticipate what thinking the regulators bring into a financial year, which will have a major bearing on the financial industry. This listing offers financial advisers an idea of what to expect during a particular financial year.

For instance, taking off from the backdrop of the financial crisis of 2007 to 2009; the…

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Added by Adam Fleming on October 13, 2017 at 6:04am — No Comments

How to create Slicers which are the New Visual way to Filter a Pivot Table

Microsoft Excel can be used to carry out a number of functions such as sorting, filtering, and subtotal to manage large lists of data. Yet, its MS Excel PivotTable is a very useful feature when it comes to analyzing all that data and doing it quickly. Its use is all the more pronounced when the user is required to quickly create a compact summary report (based on lots of data) without having to write complex formulas or rely on lengthy…

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Added by Adam Fleming on October 12, 2017 at 6:40am — No Comments

What You Need To Know For Validated Systems?

Instances of cyberattacks that lead to disruption of service, data theft or compromise and even ransomware are making the news headlines of late with alarming frequency. Cyberattacks are carried out because computer systems used in highly regulated companies house very sensitive and valuable information.

Data relating to valuable electronic submissions, clinical information, medical device design control records, legal information, and other such information are usually placed in…

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Added by Adam Fleming on October 10, 2017 at 6:26am — No Comments

What Should be Included in a Calibration Program

One of the very important activities for a laboratory is calibration. The terminology found in 21CFR160 (b) (4) spells out the requirements for this aspect of medical devices. In addition, other terminologies and concepts that need to be applied for an effective calibration program, but are not found in the regulation, such as instrument classifications, also need to be taken into consideration.…

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Added by Adam Fleming on October 9, 2017 at 6:16am — No Comments

Many UK SMBs don't invest in security solutions

A third of UK small businesses are risking their online safety by operating at or below the “security poverty line,” according to new research from Duo Security.

The cybersecurity company partnered with YouGov to survey 1,0009 senior decision makers across the UK to determine how much they are spending on cybersecurity and whether government initiatives such as Cyber Essentials and Cyber Risk Aware have been effective at protecting SMBs from cyber…

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Added by Adam Fleming on October 6, 2017 at 6:12am — No Comments

How they take on water and therefore on how they react in the process

For any product that is being produced using the extrusion process; raw materials and their characteristics are the most important variable.

Grasp of why things happen as they do in the process and why the process and product being produced react as they do, can come about only when there is a basic understanding of the raw materials and how they flow, cook and potentially over-process.

Since different types of ingredients have different properties; each ingredient reacts very…

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Added by Adam Fleming on October 4, 2017 at 6:16am — No Comments

15 ways to stay healthy in college

With crispy chicken strips and addictive fries at the Pilot House, nine seasons of The Office on Netflix and the newfound freedom of college, staying healthy and active at school can be more difficult than it was back home. Whether you’re a freshman or senior, it’s undeniable that healthy eating and self-care often takes the back burner when you have to juggle school, jobs and a social life.

Health-sayings-stay-happy-stay-healthy

Some freshmen even might worry about the…

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Added by Adam Fleming on October 3, 2017 at 6:39am — No Comments

Who are involved in filing investigational new drug applications

Lack of data integrity or the presence of anomalies in data is one of the primary reasons for which the FDA hauls up and penalizes an organization engaged in pharmaceutical manufacturing. As the use of analytical methods for drug quantification at many stages of drug development process grows in prevalence; the need for scientists, technicians, and quality assurance personnel, etc. to understand the complete validation process of the analytical method has…

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Added by Adam Fleming on September 28, 2017 at 6:19am — No Comments

U.S. asks China not to enforce cyber security law

GENEVA (Reuters) – The United States has asked China not to implement its new cyber security law over concerns it could damage global trade in services, a U.S. document published by the World Trade Organization showed on Tuesday.

China ushered in a tough new cyber security law in June, following years of fierce debate around the move that many foreign business groups fear will hit their ability to operate in the country.

The law requires local and overseas firms to submit to…

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Added by Adam Fleming on September 27, 2017 at 5:56am — No Comments

How to uncover fraud, and put a plan in place to prevent it going forward

Internal fraud, by which people who work for an organization are themselves involved in fraud, is a serious issue for businesses. This kind of fraud is very insidious, as it is stealthy and is almost impossible to detect. Accounts Payable, a core component of most organizations, is one of the primary areas of fraud. This AP fraud is something organizations don’t seem to be precluded from, no matter what the nature of their business or its size.

Yet, learning to…

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Added by Adam Fleming on September 26, 2017 at 6:23am — No Comments

Crypto-Mania Grips Hong Kong as City Looks for Life Beyond Banks

In the mid-1990s, Johnson Leung embarked on a career in shipping. In the early 2000s, he moved to finance. And now, he runs a Hong Kong startup that aims to improve how container ships are booked using blockchain technology.

Many in Hong Kong hope the city can make a similar leap. The shipping and banking hub, which has struggled for years to nurture a domestic technology industry, is embracing the blockchain revolution as it looks for new sources of…

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Added by Adam Fleming on September 25, 2017 at 5:45am — No Comments

The fourth season of Gurgaon's biggest & most popular food awards concludes with fervour

Some of the biggest names of India’s hospitality industry descended at the Hyatt Regency Hotel Gurgaon on Wednesday evening to celebrate the fourth season of ‘The Big F Awards’ – undoubtedly, Gurgaon’s biggest & most popular food awards.

The gala event was marked with the presence of bigwigs from the food & beverage…

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Added by Adam Fleming on September 22, 2017 at 5:55am — No Comments

FDA Warns on Mixing Opioid Addiction Treatments, Other Meds

TRENTON, N.J. (AP) — The Food and Drug Administration issued new warnings Wednesday about the dangers of combining medication for opioid addiction with anti-anxiety medicines and other drugs that also slow breathing and brain activity.

The FDA warned that mixing such drugs can cause difficulty breathing, coma or death, so it should be done with caution.

The agency said…

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Added by Adam Fleming on September 21, 2017 at 6:04am — No Comments

Q7 and Other Requirements for Active Pharmaceutical Ingredient (ASM) GMP

In late 2016, the FDA published the revised the Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients, Guidance for Industry. The aim of this revision is to address Good Manufacturing Practices (GMPs) for a Quality Management System for Active Pharmaceutical Ingredients (API’s). Another of its aims is to help companies ensure that they meet the requirements of API quality and purity characteristics. While replacing Q7A Good Manufacturing Practice…

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Added by Adam Fleming on September 20, 2017 at 6:27am — No Comments

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