The GDPR differs Significantly from EC Data Protection Directive 95/ 46

The General Data Protection Regulation (GDPR), which has been codified as Regulation (EU) 2016/679, is a very powerful law regarding the protection of data of the half billion people who live in the European Union (EU). Having come into effect as a result of the European Commission having adapted the proposal for its creation on January 25, 2012; it will replace Directive 95/46/EC, the data protection directive that has been in use in the EU since 1995.

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The GDPR becomes a full-fledged law and is enforceable from 25 May 2018. This is after it goes through a two-year transition period from its adaption date of 27 April 2016.

The GDPR doesn’t require members to endorse it

Just how powerful is this regulation? Well, an idea of its overarching potency can be understood from the fact that it becomes law and will be binding from the date of its enforcement without requiring legislative support from any of the EU members.

Rationale for the creation of the GDPR

The GDPR has been created for the purpose of harmonizing and strengthening all the legislative and secretarial bodies of the EU, namely the European Parliament, the Council of the European Union and the European Commission, and to tighten the various fragmented elements concerning data protection for all individuals within the European Union (EU). The GDPR also governs the export of personal data to regions beyond the EU.

It is being created to serve two important purposes:

  • Equipping EU citizens the power to control their personal data
  • Smoothening the regulatory environment and synchronizing and unifying all regulations concerning data protection regulations across the EU, and lubricating the process of doing global business within the EU.

What benefits does the new legislation offer?

The GDPR has been legislated to offer many advantages:

  • Within the company, Personally Identifiable Information (PII) will be processed with greater ease and clarity
  • The security controls in place till now will be unified and strengthened across all the EU members
  • Its stronger safeguards for data protection inspire greater customer confidence
  • The process of doing business in the EU is now a lot more simplified

What happens when companies fail to comply with the GDPR rules?

The EU mandates strict penalties for companies that fail to comply with the GDPR provisions on data protection provisions on data protection:

  • They have to pay penalties of between two and four percent of their worldwide revenues
  • Fines can go up € 20 million
  • The EU laws can initiate serious and expensive lawsuits
  • All these mean that companies obviously lose face

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These are the reasons for which companies that want to do business in the EU need to have thorough knowledge of this law and the ways in which it applies to them. This is the means to avert the expensive consequences that follow from noncompliance.

 

Proper understanding of the ways in which the GDPR works

Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will be offering a clear and thorough understanding of this new legislation at a webinar that it is organizing. Founder of GO DPO® and the Co-Director of the GDPR Transition Programme at Henley Business School and one of the leading data protection practitioners in Europe, Ardi Kolah, will be the speaker at this session.

Want to understand how Ardi will bring the varied and rich experience he has gained over the years into this very important topic? Then, please register for this webinar by visiting Features including a risk-based approach

Ardi will show how important it is for Data Controllers, Joint Data Controllers and Data Processors to address all the points relating to business continuity, risk and technology if they have to achieve the outcomes expected by the Supervisory Authorities and Industry Regulators. He will explain how to use this knowledge to build deeper trust with customers, clients, supporters and employees and a strong reputation.

The following areas will be covered at this webinar:

  • Difference in scope between Directive 95/46/EC and key data protection principles
  • Expanding the definition of personal data and special personal data
  • Enhanced individual Data Protection Rights
  • Key organisational and Personnel Changes
  • Mandatory personal data Breach Reporting
  • Global personal Data Transfers outside of the EEA and co-operation between Supervisory Authorities
  • New financial Penalties and Sanctions
  • Member State laws and the GDPR.

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

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 as State laws will continue to override networks merchant rules; companies have been looking out for ways to skirt the laws.

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The credit card surcharging issue in the US

Why is credit card surcharge an issue for businesses? It is because the credit card surcharge is the last link in the payment chain and causes a business that makes use of this facility to incur expenses. In simple terms, this is the checkout fee that gets added to every consumer’s shopping bill whenever a credit card is used to make payments for the purchases made at the business. Businesses are not willing to bear this expense and like to pass it on to the consumer.

The court judgment of 2012 permitted charging of credit card surcharge for certain card transactions from January 2013. As a result, there has been a change in not only merchant processing transactions but also of credit card usage. The settlement makes it mandatory for businesses that levy the credit card surcharge to follow requirements relating to consumer disclosure and to set limits on the amounts for which the surcharge is collected.

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They should also notify Visa and their acquirer of their decision to charge credit card surcharge a month before they begin to levy the surcharge. These rules vary from State to State, and the business is free to choose which brands of its outlet it wants to keep the credit card surcharge.

Clear the confusions about the issue

A more detailed and clear understanding of this topic will be offered at a webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance. Ray Graber, a highly experienced professional in the payment industry, who brings deep and profound understanding of the way banking and finance converge with technology, will be the speaker at this webinar.

Please register for this webinar by visiting What are the Stipulations for Compliance

Clarifying the important issues relating to credit card surcharging

Ray Graber will offer clarity on the changes in the rules and will explain who benefits from the changes, and how these changes are going to affect the retailers and customers. He will explain the perils of an uninformed reaction to surcharging by end-user organizations. He will show why it is important to first look at the big picture of credit card surcharging, since end-users should also educate suppliers about the economics of card acceptance, pointing out the savings possible and other benefits. Suppliers should not be adding a surcharge when they are reaping the rewards. Ray will explain how they might overlook the benefits of card acceptance, as well as the cost of other payment methods like checks and cash.

Being of high value and importance to every level of employee who works in the credit card industry, such as financial officers, small business owners, corporate risk officers, internal auditors, operational risk managers, credit card program administrators, CPA’s and attorneys and legal staff; this session will cover the following areas:

  • What changed in the rules?
  • Why did it change?
  • What rules apply to surcharge?
  • Survey results
  • Who may benefit?
  • Will this change anything?

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, at a ninth of that of the US.

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In terms of numbers of cyber attackers, the top cyber attackers are found predominantly in the developed world, with three of the top countries for cyber attackers belonging to the west. Germany is home to over a million cyber attackers, followed closely by the US, which had close to a million attackers in late 2013, followed by Mongolia and France.

 

A huge variety of losses

In addition to the financial loss that organizations face in the aftermath of a cyberattack, they have to also contend with other losses that are of a grave nature. Organizations in which fraud happens risk their reputation. They go down in the market as being run by incompetent and untrustworthy people at the top. Deloitte lists a number of other losses, both hidden and overt, that cyberattacks cause to organizations. These are some of them:

  • Inability to meet regulatory compliance and having to pay fines levied by regulatory agencies
  • Payment of losses and fees spent on litigation
  • Costs relating to taking measures to improve security
  • Cost of the investigation
  • Loss caused by disruption to business
  • Loss of intellectual property
  • Increased cost of insurance

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What can be done about this?

If organizations need to prevent negative scenarios such as these; they have to implement a number of security measures and procedures. These security measures need to be in the form of an Incident Response Program that will allow organizations the ability to respond to such attacks with dexterity, while at the same time making sure that their business operations do not get disrupted.

This calls for establishing Key Performance Indicators (KPI) to help to determine if organizations’ Information Systems Incident Response program meets business objectives and operational metrics for ongoing process improvement.

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Get to understand the ways of implementing cyber security

The ways of putting such a system in place will be the learning a webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance. Michael Redmond Consultant, a well-known speaker and author who also conducts ISO Certification Training for PECB, will be the speaker at this webinar. Michael is the Chapter President for Association of Contingency Planners Eastern Great Lake Chapter and an active member of ISSA.

Please log in to Business Continuity Planning to register for this webinar.

The key learning imparted by this training session is the ways of creating, testing and implementing an effective cyber Incident program to counter cyber threat and malware attacks. It will explain how to measure an organization’s susceptibility to a cyberattack. The speaker will explain the critical action areas in such events.

Ms. Redmond will explain all the measures that organizations need to take in order to avert a cyberattack, during the course of which she will discuss the following:

  • How to tailor and enhance an existing security training program and set up requirements for specific audiences
  • How to strengthen IT Risk Management – Integrate Information Security risk management with enterprise risk management
  • How to build an IS regulation review process, schedule and regulation requirements

This session will be of high value to those professionals who are at the forefront of security operations, such as Information Security Managers, CEO, CIO, CFO, CSO, Technology Managers, Risk Managers, Compliance Managers, and Auditors.

The speaker will cover the following areas at this webinar:

  • Adopting a systematic approach to risk tracking to enhance the effectiveness of the Cyber Incident Program
  • Outlining the critical actions to take if an event affects the company or its partners
  • Understanding an organizations’ susceptibility to a Cyber Attack
  • Cyber Incident Response: Getting started, research, training, testing and maintaining
  • Standards and Best Practice: ISO 27001, ISO 27035, ISO 27005. NIST, FFIEC, HIPPA and HITRUST.

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 cause.

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However, like all other technology-dependent systems; ACH’s bring their own disadvantages. Like all other modes of technological payment methods; ACH’s are prone to a variety of frauds. All that it takes to breach and impugn the systems is some smartness and knowledge of the ways in which they work within organizations or networks. Since ACH’s house almost all kinds of transactions; embezzlement into their systems can typically affect all kinds of payment methods and accounts, ranging from hacking and taking over entire individual accounts to penetration of accounts of business houses.

Companies that deal with ACH’s in one or another form –and there is no dearth of these –need to be constantly on their vigil if they have to prevent large-scale of small-scale swindling of their accounts. Their transactions need to be tightened and made as secure as possible if they have to prevent frauds.

Understanding of the ways by which ACH frauds can be prevented

The ways by which business houses can mitigate and prevent ACH fraud will be the learning a valuable webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will be imparting.

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At this webinar, Rayleen M Pirnie, founder and owner of RP Payments Risk Consulting Services, LLC, who is a nationally recognized payments risk and fraud expert who offers specialized consulting services, procedural and risk management reviews, and payments education, will be the speaker.

To gain important lessons into the ways of preventing ACH frauds; please enroll for this webinar by visiting (ACH) frauds

Explanation of the vulnerabilities and ways of handling them

Rayleen will discuss the many vulnerabilities that organizations that rely on ACH’s face. These could range from individual companies to government organizations and departments to NGO’s. Especially aimed at these kinds of organizations that deal with ACH payments for their daily transactions; this webinar will explain the best practices every organization should implement to detect and mitigate the threat of ACH fraud.

Rayleen will explain all the internal controls and processes and services that organizations of any size should discuss with their financial institution for reducing their exposure and risk. The threat of ACH fraud may be high, but much of the fraud can be averted and the potential losses mitigated if the organization knows what to look for and implement the right controls.

She will explain the various types of internal processes and controls that vary by industry and organization size. She will suggest a wide range of options and recommendations that the participants of this webinar can assess and implement based on their own internal protocols.

A bouquet of benefits from attending the webinar

These are some of the tangible benefits that the participants of this webinar will derive from this session:

  • Understanding the ways by which businesses lose thousands of dollars in seconds easily
  • Identifying sound business practices and easy to implement internal controls that are proven to reduce losses
  • Reviewing a few of the common solutions offered by financial institution to further minimize exposure

This session will be of high value to those who deal with ACH’s and other related professionals, such as AAP, CPA, Risk Managers, those in Management, and Investigators.

Rayleen will cover the following areas at this session:

  • Examples of how criminals use the ACH Network to steal from organizations
  • Restructuring and rearranging a Notebook
  • Sound business practices to minimize exposure
    • Variety of options including the dual benefits of dual control and enhanced internal approval processes
    • Enhanced internal controls
      • How criminals use an organizations technology to commit fraud
      • Securing internal payment instructions and approvals
      • Account reviews
  • Stronger account security options
    • Explore most common options including ACH positive pay, debit filters, debit blocks, credit only accounts, account alerts, etc.

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 products will be explaining these and related functions of MS Excel in a clear and easy to understand manner. Why not join David Ringstrom, author and nationally recognized instructor who teaches Microsoft-related topics at scores of webinars each year, for an enlightening webinar session on the multiple uses of MS Excel?

This webinar is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance. All that is needed to register for this highly educative and entertaining session is to visit http://www.compliance4all.com/control/w_product/~product_id=501299LIVE?Wordpress-SEO

Speaker’s rich experience at play

The major advantage that participants to this session will have is that they will learn from the honcho of Microsoft programs. David’s Excel courses are based on over 25 years of consulting and teaching experience. He believes in the mantra, “Either you work Excel, or it works you”. With this thinking in mind, he focuses on what he sees users don’t, but should, know about Microsoft Excel. His goal is to empower them to use Excel more effectively.

It is this outlook that will be of immense use to professionals such as Accountants, CPA’s, CFO’s, Controllers, Excel users, Income Tax Preparers, Enrolled Agents, Financial Consultants, IT Professionals, Auditors, Human Resource Personnel, Bookkeepers, Marketers and Government Personnel, professionals whom this webinar seeks to benefit.

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Ways of creating resilient and practical budget spreadsheets

The core of the learning of this webinar is how to create resilient and practical budget spreadsheets. David will familiarize participants with a wide range of helpful techniques, which include ways of separating inputs from calculations, streamlining formula writing, preserving key formulas, and creating both operating and cash flow budgets. An additional benefit is the explanation he will offer of the uses and benefits of a variety of Excel functions, including CHOOSE IFNA, IFERROR, and ISERROR ROUNDUP and ROUNDDOWN VLOOKUP and SUM and SUMIF.

This session is useful in more ways than one. David will demonstrate every technique at least twice first, on a PowerPoint slide with numbered steps, and second, in Excel 2016. Both during the presentation and in his detailed handouts; David will draw participants’ attention to the many differences in Excel 2013, 2010, and 2007. David will also offer an Excel workbook that includes most of the examples he uses during the webcast.

The core of this learning session is to impart the following learning objectives:

  • Learn to create both operating and cash flow budgets
  • Learn how to streamline formula writing
  • Transform filtering tasks using the Table feature
  • Understand the benefits associated with a variety of Excel functions
  • Apply and isolate all user entries to an inputs worksheet
  • Protect all calculations and budget schedules on worksheets
  • Use range names and the Table feature to create resilient and easy-to-maintain spreadsheets
  • Calculate borrowings from, and repayments toward, a working capital line of credit

David will cover the following areas at this webinar:

  • Avoiding the complexity of nested IF statements with Excel’s CHOOSE function
  • Streamlining formula writing by using the Use in Formula command
  • Improving the integrity of spreadsheets with Excel’s VLOOKUP function
  • Comparing IFNA, IFERROR, and ISERROR functions and learning which versions of Excel support these worksheet functions
  • Going beyond simple rounding with the ROUNDUP and ROUNDDOWN worksheet functions
  • Learning a simple design technique that greatly improves the integrity of Excel’s SUM function
  • Using the SUMIF function to summarize data based on a single criterion
  • Learning how range names can minimize errors, save time in Excel, serve as navigation aids, and store information in hidden locations
  • Learning how the Table feature allows you to transform filtering tasks
  • Preserving key formulas using Excel’s hide and protect features.

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 and other regulatory bodies, audits, be they internal or external; carry manifold advantages. These are some of them:

o  Organizations can apply best practices relevant to their industry through audits

o  Audits help organizations to identify where they need to improve

o  Audits play a stellar role in ensuring the quality of products, which leads to enhance customer satisfaction

o  They help organizations to take preventive actions with which bigger problems can be checked

Most organizations think of audits as an unpleasant duty

Although internal and external audits are considered so useful; it is a fact that most organizations carry them out only because it is thrust upon them. Most companies lack the conviction and volition for an audit, and drag their feet when it comes to this important task. The many benefits of an audit program are usually overlooked by 75% of companies.

What happens to organizations that are not diligent when it comes to carrying out audits? They are sure to receive penal actions from the FDA, which range from Warning Letters, 483’s to penalties to Consent Decree.

Learning session on ways of getting internal audits right

In order to help organizations get their internal and external audits right, Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will be organizing a webinar. The purpose of this session is to help professionals who need to carry out an internal audit for their organization, get it right.

The speaker at this seminar is Susanne Manz, Quality and Compliance Expert/Auditor for Medical Devices, Manz Consulting, Inc., who is an accomplished leader in the medical device industry with emphasis on quality, compliance, and Six Sigma. Participants that want to get a clear and total understanding of the rationale for carrying out audits and of the ways for get them right can enroll for this webinar by visiting http://www.compliance4all.com/control/w_product/~product_id=501303LIVE?Wordpress-SEO

An explanation of the ins and outs of auditing

Susanne will equip participants with the knowledge needed for audit professionals in organizations to put an effective and compliant audit program in place. She will help them understand what it takes to carry out a solid and thorough quality audit program that meets regulatory requirements by first being able to identify the red flags. This is the groundwork for understanding, reducing and communicating risks associated with quality and compliance.

Susanne will cover the following areas at this session:

o  Using a structured program to identify areas of risk leading to an effective audit strategy

o  How to develop a meaningful structure of audit, oversight, transparent communication, and escalation to management review

o  How to ensure your audit staff is well trained to proactively identify, communicate, and escalate issues

o  How a culture of quality and compliance can encourage clear and transparent communication of risk

o  How to prioritize, resource, and implement corrective actions

o  Tools for monitoring and communicating risk and improvement over time

o  How to identify residual risk

o  Monitoring and Controlling progress over time

o  Signs that your company culture is taking unnecessary compliance or quality risk

o  How to ensure management gets valuable information from your audit program

o  How to prioritize, resource, and implement corrective actions

o  Tools for monitoring and communicating risk and improvement over time.