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.

Relationship Between an EM Excursion Program and CAPA

The FDA’s regulations on cleanroom environmental monitoring (EM) are based on the assumption that any person who enters a cleanroom is likely and almost certain to have brought contaminants in one or another form with him. The FDA’s regulations on cleanroom environmental monitoring are built on the thinking that microorganisms can assail even the cleanest of systems, which is why its regulations on cleanroom environmental monitoring are stringent and scientific. The FDA proceeds on the thinking that nil contamination of not only cleanrooms, but all locations involved in aseptic processing is not possible.

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Based on this thinking, the FDA has formulated its guidelines on cleanroom EM taking into consideration the limitations of obtaining completely microorganism-free environment for cleanrooms. It seeks to bring about a consistent EM system that meets high environmental quality requirements all the time, being able to detect changes and deviations in this consistency level and bring the level to control limits.

Regulations that cover all areas of cleanroom environmental monitoring

Keeping this in mind, the FDA has formulated regulations that cover all aspects of cleanroom environmental monitoring, starting from the buildings and facilities, right up to the qualification and training required for personnel manning these cleanroom facilities to what should go into closures to validation of the aseptic processing and sterilization techniques. These cGMP regulations are found in 21 CFR Parts 210 and 211.

All the disciplines of cleanroom monitoring, such as quality, manufacturing, engineering, quality, environmental monitoring, sterilization and cleaning and many others need to be taken into full consideration while building an FDA-compliant monitoring program. These should be included all along, into all these phases:

  • Planning phase
  • Design phase
  • Construction phase
  • Commissioning phase
  • Qualification phase
  • Submission phase
  • Operational phase

A complete understanding of the FDA’s regulations

The ways of understanding and implementing the FDA’s regulations for environmental monitoring program will be the topic of a webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance.

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The speaker at this webinar is Joy McElroy, who in over the 20 years of total experience she has had in the pharmaceutical and biotech industries has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification. She has written and executed Equipment Qualification and Validation Protocols for numerous companies.

Want to learn the ways of understanding FDA regulations for environmental monitoring? Then, please register for this webinar by visiting

Ways of ensuring compliance

Joy will highlight the importance of compliance with the FDA regulations on environmental monitoring, as the costs of noncompliance are much more exorbitant than those of compliance. Participants who take part in this training will be able to get a proper grasp of how to implement a cleanroom Environmental Monitoring (EM) program that complies with the FDA’s regulations.

She will describe the basis of the four phases of cleanroom transitional monitoring (Pre-qualification through post-qualification EM) and explain what each type stands for. In addition to describing what has to be the basic content of a well-designed, effective and compliant EM Program; Joy will also go on to help participants comprehend the relationship between an EM Excursion Program and CAPA.

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This training session is of high value to Quality Control, Quality Assurance, Microbiologist, Facilities, Chemist, Analysts, Manufacturing, Validation, Engineering, Sterility Assurance, Compliance, Testing Technicians, Environmental Testing Personnel, Raw Materials Manufacturers, Clinical, Research and Development, and Laboratories.

Joy will cover the following areas at this webinar:

  • Applicable Regulations – Where does the EM Program fit in the Regulation? – Role of Clean room Environmental Monitoring Program?
  • Basics of Setting a Robust and Effective EM Program – Key Considerations – Relevant Material Verification Processes – Steps and Content of an EM Program Testing Procedure
  • Processing a Completed Environmental Monitoring Test Media – Sample Handling and Incubation – Documentation and Data Management of EM Test Results – What is the EM Test Data used for? – Retention of EM Test Results – Interpretation of EM Test Results
  • Basics of Designing an Effective and Compliant EM Trend Reports – Types; Content – Using Trend Report as a Critical Tool and Quality Metrics
  • Basics of Designing an Effective and Compliant EM Excursion Program – Types; Content – Handling EM Excursion Investigation – Handling Impacted Manufactured Batches – Disposition of Affected Products with Failed Clean room EM Test Results
  • Corrective and Preventative Action (CAPA) – Relationship between CAPA and EM Test Data Excursion Investigations Question and Answer Session.

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

The role of validation in HACCP

The Hazard Analysis and Critical Control Point (HACCP) is a process control system that is aimed at identifying the points or areas at which hazards (dangers) may arise in the food chain. It prescribes strict measures for manufacturers and transporters of food products to prevent contamination and the resultant hazards. Control of hazards in the food chain has always been a need, but HACCP assumes added significance in today’s world, where globalization has made it possible for food to travel to hitherto unexplored parts of the world.

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While this development has increased the choices before the consumers of food; it also brings challenges in the form of having to maintain hygiene and cleanliness standards throughout the often long food chains, usually over long periods of time. HACCP is considered a path breaking system in that it looks at food hazards very holistically and comprehensively. It seeks to control the onslaught of major microbiological contaminants in food such as E.coli, salmonella, listeria and many others that could cause diseases.

Tackling contamination from all sources

HACCP adapts a comprehensive view of all the sources of contamination, and seeks to prevent risks to food from all sources, such as:

  • Microbiological
  • Chemical
  • Physical

In addition, it also prescribes steps aimed at putting in place a hazard control system that consists of seven important steps:

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  1. Conducting a hazard analysis for identifying potential hazards that could enter the food production process
  2. Identifying the critical control points (CCPs), which are points in the process in which the potential hazards could occur and taking steps to prevent and control them
  3. Establishing critical limits for preventive measures associated with each CCP
  4. Establishing CCP monitoring requirements to ensure that each CCP stays within its limit
  5. Establishing corrective actions where monitoring shows that a CCP is not within the established limits. The aim of the corrective actions is to prevent public health hazards from occurring
  6. Establishing effective recordkeeping and documenting procedures to ensure that the HACCP system is working rightly. Documentation should show the ways in which CCPs are being monitored, as well as verification activities and deviation records
  7. Establishing procedures for verifying that the entire HACCP system is working and offering the desired outcomes.

Good intentions not backed by validation requirements  

The noble intentions behind the HACCP systems and the stringent and serious endeavors towards their implementation notwithstanding; one grouse that food experts have had of the HACCP till recently is that the validation aspect of these hazards has not been given the same importance as other factors. Validation has no doubt been a part of HACCP, but somehow, it has been sort of overshadowed by the emphasis on verification.

It is only of late that validation has been gaining in prominence as a control measure. Companies need to validate their products by properly designing and taking adequate control measures that are capable of controlling food hazards within the process.

Understanding the role of validation in HACCP

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A valuable learning session that will emphasize the importance of validation in the HACCP system is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance.

Ruth Bell, a Food Safety/Quality and HACCP Management Consultant, Auditor and Trainer, who has worked on a number of projects helping organizations throughout the food chain to design, develop, implement and verify manageable food safety systems tailored to their needs, is the speaker at this webinar. Ruth is well known for her practical Quality and HACCP knowledge as an auditor, consultant and trainer. Please register for this webinar by visiting Food Safety Control Measures

Putting in place scientific validation measures

The aim of this session is to drive home the importance of validating food safety control measures to ensure food safety management system capability. Validation of food safety control measures is an essential measure in ensuring that a food safety management system will be capable of producing safe food and remains effective over a period of time.

Validating food safety control measures requires a theoretical examination of the scientific justifications for the control measures identified and practically challenging them to determine they will be suitable and capable of consistently achieving the required level of control to ensure safe food.  Ruth will dwell on these aspects in detail at this webinar.

This webinar is aimed at HACCP team members and leaders, technical/quality managers, food safety managers, as well as auditors of food safety and HACCP systems, and specifically for specialists in positions such as HACCP Team Members, Technical Managers, Production Managers, Engineering Managers, and Consultants.

The speaker will cover the following areas at this webinar:

  • Current Guidelines for Validation
  • Differences between Verification and Validation Activities
  • Components of Food Safety Management System Validation
  • Validation Techniques including SPC, Predictive Microbiological Methods, and Challenge Testing.

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.

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?

How to control those risks and monitor the effectiveness of the controls put in place

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 products. A rigorous risk management process can prevent serious problems and costs for your company.

risk-management-definitionIn this webinar we’ll cover:

  • Overview and Definitions
  • FDA Expectations
  • ISO14971 Regulation
  • Linkages to Design Controls, Production Controls, Investigations, and CAPA
  • Risk Management throughout the product lifecycle
  • Common mistakes
  • Best Practices

Why should you have to Attend The cost of poor product risk management can be staggering. Complaints, Medical Device Reports, recalls, and serious adverse impact to your customers can all result from poor risk management. And these types of problems expose you to regulatory inspections and citations. Many companies have even experienced class action law suits because of product quality issues. An effective program of risk management can help you proactively identify and mitigate product risks. A good risk management process can help you methodically identify, mitigate, and monitor risk throughout the product life-cycle.

These are the areas covered by the speaker Susanne Manz

  • Overview of the ISO14971 standard as it applies to medical device companies
  • Integrating the new standard with ISO 13485 as part of your overall QMS
  • Conducting a review of the intended use of your device
  • Stages of Risk Management as well as Tools and Techniques
  • Identifying hazards in your product or production process, and estimating their severity
  • Judging the probability that harm may occur from those hazards
  • How to control those risks and monitor the effectiveness of the controls put in place

By login with this Risk Management Techniques for Medical Devices

Which are the experts benefited by this session are as shown in the below

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  • Design Engineer
  • Manufacturing Engineer
  • Quality Engineer
  • R&D Personnel
  • R&D Project Managers
  • Quality Managers
  • Auditors
  • Regulatory Affairs Specialist
  • R&D Manager

Susanne Manz is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. While at GE, J&J, and Medtronic, Susanne worked in various world-wide roles including Executive Business Consultant, WW Director of Quality Engineering and, Design Quality, and Director of Corporate Compliance. Susanne has a BS in Biomedical Engineering and an MBA from the University of NM.