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.

European 023456106501

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

GDPR 1235416484

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.

7 Keys to Compliance Excellence that Form the Foundation for Any Excellent Organization

In any industry, compliance is everything; be it highly specialized fields such as the life sciences, healthcare, medical devices or non-technological areas such as food and clothing. Why do companies need to be compliant? It is simply because being in compliance with the required regulatory requirements helps the organization to achieve the most positive outcomes needed for a business:

  • It earns them a good reputation
  • Increases stakeholder and customer confidence
  • Augments the value of their products or services
  • Improves performance and operations
  • Maximizes profits
  • Guarantees that they adapt the right processes.

ComplyArena_AchievingComplianceExcellence

Meeting the appropriate compliance requirements is mandatory for the regulated industries. This fact is known, but the challenge is in implementing the measures needed for achieving compliance. A compliance program that is built into the organization’s processes and of which it is an inseparable part is the way to go about achieving compliance.

A very comprehensive term

Compliance is a very broad and huge term into which many aspects are built. Compliance has to be shown at all levels by an organization if it has to achieve its outcomes and help the organization fulfil its business and other objectives. Many organizations are somewhat lackadaisical in their approach to compliance, thinking that it is an auxiliary function and not a core business activity. They cannot be more mistaken.

It is more than just a duty that needs to be completed to satisfy regulators. An organization should strive to reach levels of excellence in compliance. Those who fail to do this are not aware of the colossal opportunity they miss to stay ahead of the competition. Excellence in compliance opens the key to several unimaginable opportunities. It leads to high levels of positive results. Achieving levels of excellence at compliance standardizes and optimizes processes and makes them safe, reliable and efficient.

Understand how to achieve excellence in compliance in all its depth

Want to understand how to achieve this in all detail? Then, you could enroll for a highly educative and informative webinar on this topic that Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, is organizing. Please register for this webinar by visiting Achieving Compliance Excellence

800TD

Charles H. Paul, who is the President of C. H. Paul Consulting, Inc., a regulatory, manufacturing, training, and technical documentation consulting firm that works with both domestic and international clients designing solutions for complex training and documentation issues and is celebrating its twentieth year in business in 2017; will be the speaker at this webinar. A regulatory and management consultant and an Instructional Technologist for 30 years; Charles has published numerous white papers on various regulatory and training subjects.

Seven keys to compliance excellence

At this course, Charles will explain the seven critical keys to achieving compliance:

  • Understanding the regulations that pertain to one’s industry and business throughout each level and function of one’s organization
  • Defining the critical processes relative to the regulatory path that has been chosen
  • Developing sound regulatory documentation
  • Harmonizing processes and procedures between plants
  • Committing to and executing comprehensive technical training
  • Instituting a sound and effective complaint and investigations handling process
  • Managing performance up and down the line to the performance structure created. If it is not managed it will not be performed.

At this session, which will be ideal for Directors, Managers, Scientists, Technicians and Associates; Charles will cover the following areas:

  • Understanding the Regulations that Pertain to your Industry and your Business throughout each Level and Function of your Organization
  • Defining your Critical Processes and why that is important
  • The Benefits of Developing Sound Regulatory Documentation
  • Why Harmonizing your Processes is Critical to Consistency in Operations and Regulatory Compliance
  • Why Technical Training is Essential to every Aspect of Business Operations to include Meeting and Exceeding Regulating Requirements
  • Institute a Sound and Effective Complaint and Investigations Handling Process
  • Performance Management – the glue that holds everything together and Guarantees Acceptable Performance throughout the Organization.

Understanding and applying ICH Q3A and Q3B

The ICH Q3A and Q3B are guidances on dealing with impurities in new drug products. These documents have been issued by the FDA and are updates of earlier versions on the same topic that were prepared by the ICH, which this FDA guideline complements. This is why the documents get their name. The FDA keeps revising these documents from time to time. After every revision, the latest version carries the added taxonomy of “R” to denote that the guidance is a revised one.

international-analytical-methodology-48-728

The Q3A and the Q3B are two revised guidelines that relate to impurities in drugs. Impurities can happen due to a number of reasons. These are some of them:

  • Raw materials
  • Byproducts
  • Residual solvents
  • Reagents
  • Product reactions
  • Catalysts
  • Foreign impurities
  • Product degradation

The ICH guidelines Q3A and Q3B deal with the ways of addressing organic and anorganic substances, respectively.  They both follow the principles of reporting, identification and qualification of impurities at defined limits. They both exclude impurities arising out of the excipients of drug products.

Scope of Q3A

The scope of the Q3A guideline is limited to testing of impurities in new drug substances. It concerns itself with the content and qualification of chemical substances in new drugs. It is not meant for products derived from herbal, crude, animal or plant, or semi synthetic origin. It is also not for products in the clinical trial stage or for addressing extraneous contaminants, polymorphic forms or enantiomeric impurities.

Scope of Q3B

international-analytical-methodology-57-728

The scope of the Q3B guideline differs in some ways from that of Q3A. It is meant for the content or qualification of degradation products. It excludes products of all the sources that Q3A does, and additionally also excludes impurities arising from excipients or extractables/leachables of the container closure system.

Thorough and full understanding of these guidelines

It is to offer a complete and thorough knowledge of how to apply the Q3A and Q3B guidelines that Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will be organizing a webinar. Greg Martin, who is the President of Complectors Consulting (www.complectors.com), which provides consulting and training in the area of Pharmaceutical Analytical Chemistry and served as Director of Pharmaceutical Analytical Chemistry (R&D) for a major Pharma company for a number of years during his over 25 years of experience in the pharmaceutical industry; will be the speaker at this webinar.

To gain clear insights into how these ICH/FDA guidelines apply to your laboratory or area of work, please register for this webinar by visiting Applying ICH Q3A and Q3B for Control

All about the guidelines and regulatory expectations

The objective of this webinar is to provide participants with an understanding of the regulatory expectations for controlling impurities and degradants, including DNA reactive/potential genotoxic impurities, in drug substances and drug products.

Participants who complete this course will be able to:

  • Understand regulatory expectations regarding impurities, degradants and potential genotoxic impurities in pharmaceuticals
  • Understand what specifications will conform to regulatory expectations
  • Develop a process for reporting impurities and addressing OOS situations

Greg will cover the following areas at this webinar:

  • Landscape of impurities requiring control in pharmaceutical products
    • General impurities: elemental impurities, residual solvents, microbiological
    • Drug-related impurities process impurities, degradants, potentially genotoxic impurities
  • Process Impurities
    • Understanding ICH Q3A
    • Where impurities originate
    • How impurities are characterized
    • How specifications are developed
    • How impurities should be reported
  • Degradants
    • Understanding ICH Q3B
    • Where degradants originate
    • How degradants are characterized
      • Potential genotoxic impurities
    • How specifications are developed
    • How degradants should be reported
  • Questions and discussion

How to create processes and procedures to implement them

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.

Risk Management 27c1eb1e2dc1b8a3706b072b36cda186

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.
In 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

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. By visiting this Management Techniques for Medical Devices

product-life-cycle

Here the areas will be covered by the 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

Those who will be benefited by the session as listed in the below

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

It offers professional trainings for regulatory compliance professionals and offers innovative strategic consulting and advice to a broad range of organizations. These services help them to be compliant with regulatory requirements.

Susanne Manz MBA, MBB, RAC, CQA 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.

Understanding GLP’s and their relationship with GMPs and SOP’s

Good Laboratory Practices (GLP’s) are a series of federal regulations passed in the US by the FDA under 21 CFR Part 58. In addition, Environmental Protection Agency (EPA) also has formed GLP’s both for Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) in 40 CFR Part 160 and for Toxic Substances Control Act (TSCA) in 40 CFR Part 792.

Biotechnology concept

GLP’s are Quality Systems that relate to the processes and conditions that organizations carrying out nonclinical studies concerning health and the environment have to comply with. The objective of creating these processes and conditions is to ensure proper planning, performance, monitoring, recording, archiving and reporting of these studies. GLP’s are not just guidelines; they have the effect of a law.

The intention of framing GLP’s is that a minimum standard has to be established for conducting nonclinical laboratory research. This acts as the basis for research or marketing of products that are regulated by the FDA or the EPA. Typically, products that come under GLP’s include:

  • Animal food additives
  • Medical devices that are meant for human use
  • Biological products
  • Pesticide products
  • Human and animal drugs
  • Electronic products

Cosmetic products do not come under GLP’s.

An understanding of GMPs

good-manufacturing-practices-4-638

Good Manufacturing Practices or GMPs are quality assurance standards which ensure that consistency and control go into the manufacture of products and that these products are in accordance with their quality standards that are required for their Intended Use and in conformity with the Market Authorization or the specifications that the product has to have.

What are SOP’s?

Standard Operating Procedures (SOP’s) are detailed written instructions that are aimed at bringing about maximization of safety and efficiency in the operations of select types of organizations such as:

screen-shot-2015-09-14-at-13-35-01

  • Pharmaceuticals
  • Clinical research
  • Emergency response
  • Government
  • Power

 

 

 

 

How are GLP’s related to GMPs and SOP’s?

Do GLP’s, GMPs and SOP’s have a close relationship with each other? How are they, all being vital elements of the industries to which they relate, connected with each other? GLP’s have nothing to do with GMPs, but what about SOP’s? What is the nature of the similarities between these and what are their differences?

This will be the important learning a webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will offer. At this webinar, the speaker is Joy McElroy. During the over 20 years of working in the pharmaceutical and biotech industries, Joy has gained extensive knowledge of Quality Assurance, Process and Cleaning Validation, and Equipment Qualification, which has enabled her to write and execute Equipment Qualification and Validation Protocols for several well-known companies.

To comprehend the nature of the relationship between GLP’s, GMPs and SOP’s, please register for which webinar by visiting Associated with GMPs and SOPs

Comparison and differences between GLP, GMP and SOP

Professionals such as Quality Assurance Personnel, Quality Control Personnel, Research and Development Personnel, Regulatory Affairs Personnel, Project Managers, Manufacturing Managers, Validation Engineers, Internal Auditing Personnel, Microbiology Personnel and Auditors will learn everything from:

  • What GLPs are
  • Why they were created
  • The objective of GLP’s
  • How they relate and are associated with GMPs.

Joy will explain what GLP’s are and help participants understand and compare the differences with GMPs.

 

Steps to IEC 60601-1 approval

The 60601-1 is a standard that relates to the safety of medical electrical equipment. This harmonized standard is recognized by most countries around the world. Existing and new medical devices have to comply with the requirements set out in IEC 60601-1.

The IEC 60601-1 is going through its latest revision, its 3rd edition, which came into effect in June 2012. The regulatory agencies of various countries that have adapted this standard are in various stages of implementation. Documentation and certification for IEC 60601-1 is to be done in stages at various dates, which will go up to 2018.

60601

Major product safety changes brought about by the 3rd edition

Through the publication of Amendment I, IEC 60601-1 brings in around 20 new requirements and some 60 modifications to the existing requirements. The major change IEC 60601-1’s latest version, 3.1 of the 3rd edition brings is that it makes a risk management file and process that aligns with ISO 14971 mandatory for manufacturers of medical electrical equipment. The ISO 14971 is the global standard that applies to risk management in medical devices.

The IEC 60601-1 3.1 Edition also requires design review and third party approval for medical devices. In addition, this version has also modified requirements in relation to these among many other areas:

  • Essential Performance
  • Documentation
  • Humidity
  • Marking and Labeling
  • Temperature Testing
  • Programmable Electrical Medical Systems (PEMS)
  • Mechanical Hazards
  • Electrical Hazards
  • Construction

risk-management-in606011-14-638

Stay clear of the complexity

Want to understand the ways by which the new IEC 60601-1 version works for your organization? Want to clear the confusions regarding implementation of the new IEC 60601-1 standard and gain acceptance by meeting compliance requirements set out by the various regulatory agencies? A webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance will provide all the answers.

The guru of IEC 60601-1, Leonard Eisner, will be the speaker at this highly insightful session. The Founder and Principal Consultant at Eisner Safety Consultants, which specializes in helping medical device manufacturers through product safety, international regulatory (FDA 510(k), CE Mark, Canadian Medical Device Regulations (CMDR), etc.) and quality system processes; Leo, a licensed professional engineer in safety engineering, a Notified Body and Quality System auditor/technical reviewer, an expert in product safety for medical electrical devices (IEC 60601 series of standards) and an expert in CE marking for the medical device EU Directives, has helped countless clients through the Product Safety and Regulatory maze over his career.

To register for this highly interesting and relevant session, please visit 16 Steps to Get Approval to IEC 60601-1

Learning from others’ mistakes

Leo will help participants accelerate their time to market. He will show how to follow the steps and hasten the speed at which they can obtain their product certification to IEC 60601-1 series of standards. All the expectations for product testing set out by certification agencies to the IEC 60601-1 series of standards on medical electrical equipment and systems, such as UL, TUV, BSI, Intertek, etc., will be explained.

An important element of the learning at this webinar is the ways by which to learn from the mistakes Leo has seen others make that have gone on to slow their certification process. He will show the participants what proactive steps they can take to avoid these mistakes and ensure that their product doesn’t need to get redesigned after testing starts.

isoiec80001-do-we-need-another-standard-14-638

Leo will cover the following areas at this webinar:

  • Learn about the scope of the IEC 60601-1 standard & if it applies to your product. Also, what are the Collateral Standards (IEC 60601-1-X) and Particular Standards are about
  • What you need to know to classify your products to the IEC 60601-1 series
  • What is an isolation diagram and how does that help me with my design?
  • Determine the applicable tests for your device
  • What are the marking and labeling requirements for the device?
  • Know your critical components
  • What pre-tests to run and what’s not worth pre-testing?

Uniform Customs and Practice standard and can be negotiated by over 30,000 banks worldwide

Letters of Credit are the primary instruments for assuring payment of goods sold internationally. This web session is designed to provide attendees with an end-to-end understanding of the L/C (letter of credit) process. From the beginning of a contractual agreement, through the letter of credit application process and actual negotiation of the L/C, this information-rich webinar will provide techniques that are indispensable to both importers and exporters.

WF_LC_Graphic

Why should you attend your staff should understand Letters of Credit. Even in today’s free trade-oriented business environment, companies must exercise particular caution when agreeing on payment terms. With financing choices that include cash in advance, open terms, letters of credit (L/C), sight drafts and time drafts, both importers and exporters need to understand the true implications of their credit policies and practices. By login with this Letters of Credit for Importers you may know.

These Things of the areas will be covered by the speaker Douglas Cohen

  • Gain a Comprehensive Understanding of the Letter of Credit Process
  • Learn how to Negotiate the Terms of both Import and Export L/Cs
  • Be 100% aware of Letter of Credit Documentation requirements
  • Be Aware of all Expenses Associated with Using Letters of Credit
  • Learn how to Avoid Amendments and Discrepancies

Understand the role of banks and freight forwarders in the L/C process.

how-does-letter-of-credit-work

  • Documentary Credits Defined
  • Letters of Credit for Exporters
  • Sight Drafts and Time Drafts
  • Documentation Requirements
  • Letters of Credit for Importers
  • The Letter of Credit Process
  • Amendments and Discrepancies

Those who are the experts benefited by this

  • Exporters
  • Logistics and Trade Professionals
  • International Sales Executives
  • Customs Brokers
  • Freight Forwarders
  • Airlines
  • Steamship Lines
  • International Banking Personnel
  • Professors and Students of Global Trade

D_Payment

Douglas Cohen has been at the forefront of international trade and transactions. With positions in private law practice, US Department of Commerce, the European Union, IATA, and American Airlines, he has developed significant expertise in import-export operations and compliance, global transactions, international negotiations, intellectual property, and cross-cultural business communication. At present, Mr. Cohen is Senior Manager, Global Trade and Contracts at Worldwide Trade and Legal Associates (WWTL), where he provides legal and strategic advice to organizations seeking to enter or expand foreign markets.

In addition, he is the director of WWTL’s Global Trade Compliance Training division, where he offers comprehensive import-export training to private companies, universities, and pubic organizations.

Mr Cohen has been asked to teach university courses and corporate seminars on international business and law in the US, Europe, Asia, and the Middle East. He is the author of numerous publications on Internet law, international contract negotiations, intellectual property protection, and import-export operations and compliance.