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 financial regulatory priorities listed out in a study carried out by Harvard included the following:

o  Increased capital regulation

o  Improved stress testing and capital planning

o  Regulation of the liquidity requirements

o  The need for learning the tools for regulatory migration across financial institutions

o  The authority the regulatory agencies have in regulating large financial institutions

These constitute the broad items of financial regulatory priorities. Financial advisers may use these financial regulatory priorities issued at a particular point of time to make assessments and calculations that help them arrive at decisions which they pass on to investors. However, different priorities emerge from time to time, simply because the financial situation is fluid and ever evolving.

Based on evolving priorities and situations

Financial advisers may make valuations and offer honest advice to investors about the financial markets, but these can be subject to flux. In the event of these changing goals and situations; it is not possible to arrive at black and white conclusions about the priorities.

Financial professionals and those who take their advice need to be fully alert to the happenings in the financial landscape if they have to arrive at the right decisions. How do they do that? What is the basis on which the exam initiatives need to be understood in order to facilitate sensible decision-making about finance?

Learning about how to understand exam initiatives

This is what a webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will be offering at a webinar. This webinar will have Lisa Marsden, IACCP, who is the President and Founder of Coulter Strategic Services. Coulter Strategic Services, which provides Financial Advisors and compliance consulting firms with compliance and project management services, as the speaker.

Please visit day to day tasks of financial compliance to enroll for this webinar and gain clarity in understanding the details set out in the regulatory exam initiatives.

Understanding how the priorities suit participants’ organizations

The speaker will explain what each financial industry participant needs to know about this year’s regulatory initiatives. She will highlight the importance of learning from priorities that are involved in the day to day tasks of financial compliance.

She will show how participants can learn the ways of reviewing the regulator’s annual priorities list and incorporating the priorities that relate to their own firm into their compliance program. The ways by which to test the specific areas and how to remediate any issues found, will be explained. Beyond the priorities, Lisa will also show how to find out what to expect from exams and how to test the suitability of the participants’ compliance program based on what the regulators are focusing on.

Lisa will cover the following areas at this webinar:

o  Learn how to gain access to the financial regulators priorities

o  Understand how to apply those priorities to your firm

o  Incorporate the priorities into your annual review

o  Distinguish which priorities need to become part of the Compliance Manual/Code of Ethics

o  Determine what your firm’s financial regulatory priorities should be

o  Other sources for annual priorities.

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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 growth.

Skeptics say it’s a risky bet on an unproven technology — one with more than its fair share of hype and, in some cases, fraud. But a growing number of Hong Kong entrepreneurs and policy makers are convinced the online ledger system that underlies cryptocurrencies like bitcoin will eventually reshape everything from financial services to supply chains. They say the city’s laissez faire approach toward regulation, along with its expertise in finance and logistics, make it a natural hub for blockchain startups.

“I don’t see why Hong Kong can’t be a leader of blockchain technology,” said Leung, who co-founded 300cubits.tech after more than a decade in the financial industry that included stints as a research analyst at JPMorgan Chase & Co. and Jefferies Group LLC. “It’s so new that it’s not like any country has a huge advantage compared to us.”

Hong Kong’s government has been throwing resources at the technology. The city’s monetary authority is developing its own digital currency and is testing blockchains for trade finance, mortgage applications and e-check tracking. Hong Kong’s securities regulator has joined R3, a global consortium that develops blockchain technology for financial transactions, while a government-backed research institute has worked on a blockchain-based system for tracking property valuations, among other initiatives. Hong Kong Exchanges & Clearing Ltd., the city’s publicly-traded exchange monopoly, plans to start a blockchain platform for early-stage companies and their investors next year.

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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, time series analysis uses visual methods to plot data over time.

A common technique plots the data to help detect trends, cycles, and shifts. The major use of these valuable methods is that they can help anticipate problems before they occur and demonstrate the effectiveness of corrective actions.

A webinar from Compliance4All on time series analysis

Dan O’Leary, President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management, will be the speaker at a webinar that analyzes time series analysis. This webinar is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance.

Please visit methods when the data has a time based order to register for this webinar on time series analysis.

Full explanation of time series analysis

At this session, Dan will explain the graphical methods. In addition, he will also demonstrate some analysis techniques using Excel. Some special cases including data smoothing using moving averages, analysis with a lag function, and statistical process control (SPC), will be explained. By attending this webinar, participants will be able to gain understanding of time series analysis and some Excel capabilities to help perform the analysis. These tools are valuable for improvement projects and reporting information to management.

When the appropriate method is not clear, data analysis can be difficult. At this webinar, Dan will explain the methods when the data has a time based order. Excel includes functions and methods that can one can use to analyze the data and present it in a meaningful way.

Meaningful objectives

In this webinar, which will be of immense use to professionals who use statistics in their quality requirements, such as Quality Engineers, Manufacturing Engineers, Design Engineers, Data Analysts, Auditors, CA&PA Specialists, and Quality Managers; Dan will impart the following objectives:

o  Using run (trend) Charts

o  Determining a Linear Trend

o  Data Smoothing (Moving Averages and Lag Functions)

o  Using variables Control Charts(x-bar & R).

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: Different regulations have to be made depending on whether the software in medical devices is to be classified as a device itself, is used to alter the performance of the device, or is used for computing values. The inability of the regulatory agencies to catch up with the speed of developments in the medical device software arena has had the agency scurrying for quick solutions.

Among these are its decision to integrate the current provisions of voluntary standards developed by the National Institute of Standards and Technology (NIST), which it considers as a useful guidance for medical software professionals and voluntary information sharing organizations to meet cybersecurity challenges into its regulatory oversight. The onus of being knowledgeable about FDA regulations thus rests on firms that design and market software.

Learning on all the aspects of medical device cybersecurity

A formal learning session that examines this complex relationship is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance. The speaker at this webinar is Casper Uldriks, ex-FDA Expert and former Associate, Center Director of CDRH. Participants who wish to gain clarity on these aspects of medical device cybersecurity can register for this webinar by visiting National Institute of Standards and Technology

The speaker at this webinar will seek to help participants identify the FDA’s fundamental premarket and postmarket requirements that involve software. When medical device companies go to the FDA for approval to market their product; they need to be very well informed about everything that the FDA states and requires in this regard, because, as we have examined, the burden of design factors requires well informed considerations about how medical device manufacturers protect their product’s software and how they outsmart increasingly sophisticated cyber attackers.

All-round plans

At the same time, device manufacturers also need to be totally compliant with the regulatory options and responsibilities lie with them when a cybersecurity problem is located in their device. Their responsibilities include plans about how to recover and publicly disclose cyberattacks, especially when private medical records are involved. Not getting this right leads to fines that run into millions of dollars for every breach.

So, their cybersecurity efforts should be inclusive of important factors such as these among others:

o  Design planning

o  Postmarket vigilance

o  Training for employees

o  An action plan for managing an attack.

Learning on the factors to consider

Casper will help participants identify these basic considerations at this webinar. He will explain the kind of device cybersecurity programs that protect and foster the performance of device based software or standalone software that device manufacturers need to instill in order to assure the safe use of the device. Such programs need to use the FDA’s premarket and postmarket information requirements when entering and staying in the market.

This session is of very high value to professionals who deal with some or another form of medical device software and its marketing. This includes those in Regulatory Affairs, Quality Assurance, Software Design Engineers, Manufacturing, the Complaint Department, Hospital Risk Department, and those who market their own labels.

Casper will cover the following areas at this webinar:

o  FDA’s Cybersecurity Premarket Design Information

o  FDA’s Postmarket Controls

o  Voluntary Controls

o  Cybersecurity Training

o  Recovery Plans.

Tool for Checking Corporate Revenue Accounts Frauds

Corporate revenue account fraud and account manipulation are serious issues for businesses in many parts of the world today. Although legislations such as Sarbanes Oxley have been passed with the intention of making corporates more accountable; corporate accounting is still vulnerable to manipulation and fraud. A company’s financial statement is a primary area in which a fraud can happen.

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A financial statement is the elementary piece of documentation which reflects a company’s financial stature. It mirrors the company’s financial health, and is the document that is taken up as reference for discussion and clarification during shareholders’ and board members’ meetings. Since they contain information about cash flows, balance sheets and income statements; financial statements are the reference point for judging the financial situation of a company.

Why does fraud take place in financial statements?

Financial statement fraud can happen for a number of reasons:

  • It can be carried out to deflate figures, so that shareholders may be paid lesser dividends than they deserve
  • Financial statement fraud can also be to report lesser incomes, so that the company pays lesser tax
  • They can also be inflated to raise more funding and capital

Financial ratios as a means of detecting financial statement fraud

Among the many mechanisms used for detecting financial statement frauds; financial ratios are an important one. They can be used to analyze and interpret the numbers in financial statements to arrive at an understanding of important aspects such as the following among others:

  • Is the company holding excess inventory unnecessarily?
  • Is it running a heavier debt than is necessary or manageable?
  • Are the payments from customers coming rightly, fully and on time?
  • Is the company spending a lot more on production than is necessary, i.e. is its operating expense on the higher side?
  • How is the company utilizing its resources and assets to generate revenues?

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Ways of using financial ratios to detect frauds

A financial analyst, or anyone connected with the company’s financial statements, such as a chartered accountant, auditor, stakeholders, and board members and so on, can use financial ratios to quickly analyze the situation. Whenever there is a change in the allocation or revenues from each source, the extent to which the changes happened needs to be explained. Unless there is a reasonable or convincing reason for which the values change from one year to another; it becomes a potential red flag that is worth investigating into.

And the percentage or extent to which the ratio changes in relation to the industry average can also be used as a reference. If the industry average for a certain item is say, 15% of the expense, and if there is a perceptible change in it from one year to another in a company’s financial statement, then that is something that needs to be looked into.

These are just a couple of examples of how ratios can potentially show up mismatches and anomalies in the financial statement.

Full learning on how to use ratios for detecting fraud

Is there a way of detecting these account frauds before they happen? Which are the warning signs and red flags that need to be taken note of when checking financial statements, so that these frauds are detected early, and the damage limited?

A webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will show which these are, and how they can be used. This webinar will offer an in-depth, professional way of using ratios for detecting financial fraud in companies.

At this webinar, Mike Morley, who is a Certified Public Accountant, business author and an entertaining and informative speaker and a recognized authority in the field of finance, will be the speaker. Mike offers various training programs, such as IFRS, SOX, and Financial Statement Analysis that focus on providing continuing education opportunities for finance and accounting professionals. It is this wide-ranging experience that Mike brings into this session on using ratios for fraud detection.

Please register for this webinar by visiting Detection in Corporate Revenue Accounts Michael will offer an overview of some of the best practices in ratio analysis for fraud detection in corporate revenue accounts used today. This will be highly useful to participants from the Finance sector, such as Accountants, CFO’s, Auditors –External and Internal, Business Managers, Forensic Accounting Researchers, and Fraud Investigators.

Mike will cover the following areas at this webinar:

  • External Pressures that Might Lead to Committing Financial Reporting Fraud
  • Internal Red Flags that Might Affect the Revenue Accounts
  • Ratios that Help Spot Unusual Financial Results
  • Ratios that Indicate which Transactions should be Analyzed in Detail
  • Ratios for Finding Account Balances that Might be Inflated

Ratios for Verifying the Relationship Between revenue and other Accounts.

Latest Trends in Human Error Issues in the Industry

To say that the manufacturing industry is huge is to make a huge understatement. It is an activity that spans entire industries and is the lifeblood of many economies, right from advanced to developing ones. Despite the advancement in automation in the processes of many industries, manufacturing is still heavily dependent on human labor.

This makes manufacturing an activity that is prone to human error, because wherever there is human involvement, there is scope for human error. Why is this so? It is because as humans, we are not perfect. With all the care and diligence that one is capable of taking, human errors can somehow creep into a manufacturing process.

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Huge costs associated with human errors

There are enormous costs associated with human error in manufacturing, no matter whether the error is intended or unintended. At times, it can affect other activities in the chain and disrupt the process. A human error can sometimes set up a whole chain of errors. Because of this, it is not always possible to make a precise assessment of the loss caused by human error. Yet, rough estimates that the American and British pharma industries suffer put the loss at some $25 billion a year. Human error in this industry leads to unexpected runtime error, resulting in loss of more than a third of the productive time. Human error can result in many losses relating to quality and production and is at the root of many performance issues.

Understanding human error

Even with all the advancements and developments in high end, precise technologies and processes; it is not likely that human error will be eliminated at any point of time. At best, it can only be mitigated and minimized.

Get to the source first

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Many a time, the response to a human error is piecemeal and ad-hoc. Instead, the first step towards containing human error should be to locate its source. Human error starts right at the design stage. The prudent approach is to thoroughly understand the root cause and reduce the likelihood of human error by going deep into the variables and causes that bring about human error. Training is an option, but it is surprising that lack of proper training accounts for just a tenth of human errors.

Getting to the root of human errors involves having to control the procedures, training, and workplace environment where many variables that affect human behavior fuse. In order to understand the cause and nature of human error, one needs to directly address the systemic weaknesses to improve or fix them. To do this, it is necessary to get an understanding of human behavior and the psychology of error. Implementation of human factors in manufacturing, the right communication, encouraging continuous practice, the right kind of training, describing the right procedures and offering instructions, facilitating a positive work environment and putting the right processes in place are some of the matters that involve going to the root of human error.

Thorough trainings to help understand human error

A webinar from Compliance4All, a highly acclaimed provider of professional trainings for all the areas of regulatory compliance will offer a complete understanding of the nature of human error, its roots, its psychology and everything else connected with it.

The speaker at this webinar is Ginette Collazo, a human error and human behavior expert who has spent more than 15 years in technical training, organizational development and human reliability areas. Please visit Controlling Human Error to understand the whole autonomy of human error.

Practical approaches to all areas of human error

This webinar seeks to help regulatory and quality professionals get a thorough idea of the factors that cause human error. Towards fostering this, the speaker will offer practical approaches and tools to address human performance issues in manufacturing. She will offer an understanding of the human psychology and behavior behind human errors. This will point to where the weaknesses lie, which will help to address the human performance issues. The aim is to help correct and prevent recurrences of human error.

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Ginette will cover the following areas at this webinar:

  • Background on Human Error Phenomena
  • Importance of Human Error Prevention/reduction
  • Training and human error
  • Facts about human error
  • Human Error as the Root Cause
  • What is Human Error?
  • How is Human Error controlled?
  • Common mistakes Memory failures, Overconfidence, We believe we are above average, Visual Detection, Vigilance Effectiveness
  • Types of error
  • Human error rates and measurement
  • Trending and tracking
  • Prediction
  • CAPA effectiveness.

For referal Websites

http://learnaboutgmp.com/the-top-7-how-to-reduce-manufacturing-human-error/

https://hbr.org/1989/03/the-human-costs-of-manufacturing-reform

http://www.pharmtech.com/human-error-costs-industry-billions

MS Excel can be a wonderful tool for carrying out umpteen functions

Mastering MS Excel formulas and functions can make a miracle out of this program. When used optimally, MS Excel can be a wonderful tool for carrying out umpteen functions and optimizing work related to a number of departments. For example, the Accounts Department can do a number of important functions such as loan repayment calculation, generating a profit and loss statement, solve complex mathematical and engineering problems, and carry out anything that involves addition, subtraction, multiplication and other functions with utmost ease.

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This is because MS Excel has a number of built-in tools. If a user knows how to use these; it could be a real blessing, because it carries out a number of complex tasks at the touch of a button. The user of MS Excel only needs to know how to use these functions. The features range from simple sum and average to the IF and VLOOKUP functions.

Goes beyond calculating and arriving at data

The major advantage of maximizing the use of MS Excel is that it saves lots and lots of time for the user. Be it a student or an accounts executive; MS Excel helps them to make the best use of time, as they will be required to spend a lot lesser time on functions since MS Excel does it for them.

Calculation of and arriving at data is not the only function MS Excel is capable of carrying out. Calculating someone’s exact age in days, combining text items from several cells into a single cell or converting a list of lower case text items to capital letters are just some of these. And what is MS Excel’s capability in relation to creating financial data and models? It is perfectly useful here, too.

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Discover the ways of optimizing the use of MS Excel

Want to understand how to make MS Excel work magically for you? Then, a webinar from Compliance4All, a leading provider of professional compliance for all areas of regulatory compliance, will show you how. The speaker at this extremely useful session is none other than Mike Thomas, a subject matter expert in a range of technologies including Microsoft Office and Apple Mac, who has worked in the IT training business since 1989.

From the time Mike founded theexceltrainer.co.uk; he has produced nearly 200 written and video-based Excel tutorials. To be able to make your MS Excel a much more efficient program and help it save you enormous time and resources; please get the most out of the learning from this webinar by enrolling for it at Creating complex functions the easy way

1ec5ef5b-96a1-4353-96c2-c9a26ad2adc5This session is ideally suited for any Excel user who needs to go beyond the basics of using formulas or simply wants to become more comfortable and productive in using Excel formulas and functions. Any Excel user who deals with large lists needs these tools and techniques to effectively manage the lists and become more productive. This program can be a good fit for anyone who is above the entry level.

Mike will cover the following areas at this webinar:

  • Creating formulas to perform mathematical calculations
  • Copying formulas and the difference between absolute and relative references
  • Assigning names to cells and using them in formulas
  • Using functions to combine text strings from multiple cells
  • Using functions to change text from lowercase to uppercase and vice versa
  • Using functions to perform calculations on dates and times
  • Using the IF function to automate data entry
  • The VLOOKUP function
  • Creating complex functions the easy way.