Online Safety Community

Adam Fleaming's Blog (160)

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…

Continue

Added by Adam Fleaming 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…

Continue

Added by Adam Fleaming on October 16, 2017 at 6:12am — 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…

Continue

Added by Adam Fleaming on October 13, 2017 at 6:03am — 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…

Continue

Added by Adam Fleaming on October 12, 2017 at 6:38am — 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…

Continue

Added by Adam Fleaming on October 10, 2017 at 6:25am — 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.…

Continue

Added by Adam Fleaming on October 9, 2017 at 6:15am — 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…

Continue

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

Artificial intelligence set to revolutionise future occupational health delivery

“Technology will replace many doctors, and other professions.” This headline caught my eye in October 2016 when I was preparing a presentation for the Medgate UK annual conference.

The article, from the Harvard Business Review (Susskind R and Susskind D, 2016), has become my wake-up call. It states that faced with the claim that artificial intelligence (AI) and robots are poised to replace most of today’s workforce, most mainstream…

Continue

Added by Adam Fleaming on October 5, 2017 at 6:08am — 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…

Continue

Added by Adam Fleaming on October 4, 2017 at 6:15am — 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…

Continue

Added by Adam Fleaming on October 3, 2017 at 6:37am — 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…

Continue

Added by Adam Fleaming on September 28, 2017 at 6:18am — 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…

Continue

Added by Adam Fleaming on September 27, 2017 at 5:55am — 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…

Continue

Added by Adam Fleaming on September 26, 2017 at 6:22am — 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…

Continue

Added by Adam Fleaming on September 25, 2017 at 5:44am — 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…

Continue

Added by Adam Fleaming on September 22, 2017 at 5:54am — 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…

Continue

Added by Adam Fleaming on September 21, 2017 at 6:02am — 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…

Continue

Added by Adam Fleaming on September 20, 2017 at 6:26am — No Comments

Nitinol-based Medical Devices 2017 Global Market Expected to Grow at CAGR 10.50 % and Forecast to 2021

About Nitinol-based Medical Devices

Nitinol-based medical devices are made of nitinol, an alloy of nickel and titanium. The use of nitinol-based stents and guidewires has improved procedural outcome. The nitinol alloys are corrosion resistant and are highly accepted in the medical device industry. The global medical devices market has been growing extensively over the years. With increasing investment in research and development (R&D) for manufacturing…

Continue

Added by Adam Fleaming on September 19, 2017 at 6:03am — No Comments

A common technique plots the data to help detect trends, cycles, and shifts

Some of the functions of medical device manufacturers include:

o  Analyzing complaints

o  Processing data

o  Evaluating nonconformances

o  Utilizing other quality data sources.

The main purpose of this analysis, done using appropriate statistical methodology, under §820.100, is to identify the cause of nonconforming products and other quality problems. Time series analysis is one such family of these tools. Also called trending analysis,…

Continue

Added by Adam Fleaming on September 18, 2017 at 6:49am — No Comments

Which leads to fines in the millions of dollars per intrusion

Developments in the area of medical device software –i.e., the software that is put to use in medical devices –have been taking place at such a torrid pace that regulatory agencies such as the FDA have been unable to keep pace with them. Almost invariably, every development in medical device software brings about a new level of complexity.

Also, the classification of the device is another factor the FDA and other regulatory agencies have had to contend with:…

Continue

Added by Adam Fleaming on September 14, 2017 at 6:22am — No Comments

Take our poll!

Take our poll!

Latest Activity

Training Doyens posted events
1 hour ago
Adam Fleaming posted a blog post

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 CPA’s and the parties. This section has…See More
19 hours ago
John Robinson shared their discussion on Twitter
19 hours ago
John Robinson posted a discussion

Risk Management Solutions

Risk is defined as the potential hazard, harm or side effect of an activity. Almost all activities come with some or another form of risk, which needs to be mitigated or eliminated. Risk management is a major issue for regulatory compliance professionals. Our resources directory is a medium that helps them understand and overcome challenges. A few ISO standards, such as ISO 9004 cover risk management.Risk Management is a key component of ISO 9004:2000There is an intricate link between ISO…See More
19 hours ago

Forum

Risk Management Solutions

Risk is defined as the potential hazard, harm or side effect of an activity. Almost all activities come with some or another form of risk, which needs to be mitigated or eliminated. Risk management…Continue

Tags: risk, Banking, management, healthcare, Process

Started by John Robinson 19 hours ago.

Occupational Health and Safety 4 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 John Robinson yesterday.

Introduction to PEGA-PRPC

Pega/PRPC is a popular rules engine and BPM tool from Pega systems that is gaining good market share among large corporations. Architects and developers build the Pega/PRPC instance while…Continue

Tags: training, course, online, pega

Started by Soujanya Naganuri Oct 6.

Introduction to PEGA-PRPC

Pega/PRPC is a popular rules engine and BPM tool from Pega systems that is gaining good market share among large corporations. Architects and developers build the Pega/PRPC instance while…Continue

Tags: training, course, online, pega

Started by Soujanya Naganuri Oct 6.

Introduction to PEGA-PRPC

Pega/PRPC is a popular rules engine and BPM tool from Pega systems that is gaining good market share among large corporations. Architects and developers build the Pega/PRPC instance while…Continue

Tags: training, course, online, pega

Started by Soujanya Naganuri Oct 6.

Badge

Loading…

© 2017   Created by Safety Community.   Powered by

Badges  |  Report an Issue  |  Terms of Service