How to Comply and how to Protect Privacy

The General Data Protection Regulation (GDPR) –codified as Regulation (EU) 2016/679 – is an important law concerning the protection of data of all people living in the European Union (EU). Through the GDPR regulation; all the legislative and secretarial bodies of the EU, namely the European Parliament, the Council of the European Union and the European Commission, fortify and toughen and unify all aspects of data protection for all individuals within the European Union (EU).

Business, Technology, Internet and network concept. Young businessman showing a word in a virtual tablet of the future: Data protection

Another area that is addressed by the GDPR is the export of personal data to regions outside the EU. The core purposes for which the GDPR is enacted are twofold:

  • Giving control back to citizens and residents over their personal data
  • Simplifying the regulatory environment and bringing about uniformity and unity in data protection regulations across the EU to facilitate the ease of doing global business within the EU.

The GDPR will be the new law without requiring members to endorse it

The GDPR came into effect when the European Commission adapted the proposal for its creation on January 25, 2012. When the GDPR comes into effect and becomes enforceable from 25 May 2018 after a two-year transition period after being adopted on 27 April 2016; it will replace the data protection directive that has been in use in the EU from 1995: Directive 95/46/EC.

The all-powerful nature of this regulation can be gauged from the fact that it does not require legislative support from any of the EU members. It straightaway becomes law and will be directly binding and applicable from the date of its enforcement.

Benefits of the new legislation

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The GDPR will come with many advantages:

  • It will offer greater and clearer insight into Personally Identifiable Information (PII) processing within the company
  • It will boost security controls and unify these across the 27 EU members
  • It brings about increased customer confidence, since there are stronger safeguards for data protection
  • It will relax the process of doing business in the EU

Drawbacks of the GDPR for companies that want to do business in the EU

While the primary objective of the GDPR is smoothing the laws for allowing global businesses in the bloc; it comes at a rather expensive price tag: If companies fail to comply with the GDPR provisions on data protection, they end up coughing up two percent of their worldwide revenues in penalties!

These are some of the other pain areas of the GDPR:

  • Provisions stipulate fines of up to € 20 million
  • Inviting a host of complicated lawsuits
  • Loss of reputation
  • A host of liability cases

These facts about the GDPR make it necessary for companies in any line of business that want to gain access to the huge EU market to get a complete and clear grasp of the nuances of this new legislation. This is absolutely necessary if they have to avoid the consequences of noncompliance.

Get to understand the ways of the GDPR

This is the learning that a webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will be offering. Derk Yntema, who has over 15 years of experience in ICT and security-management and has demonstrated capacity to implement innovative security programs that drive awareness towards information security and strengthen organizations and proven knowledge of privacy legislation and helping companies towards privacy compliance, will be the speaker at this session.

To get a full and proper understanding of the GDPR and how it affects your business, please register for this webinar by visiting Security Controls up to level

At this webinar, which will be of very high value to professionals such as Board of Directors, Supervisory Board, CxO’s and Compliance Managers/Officers; Derk will cover the following areas:

  • What is Privacy?
  • How to Protect Privacy
  • What is PII?
  • What is in the GDPR (General Data Protection Regulation)
  • How to Comply.

Understanding opportunities in NAFTA

The North American Free Trade Agreement (NAFTA) came into being on the first day of 1994. While the US and Canada had been having free trade agreements that go back at least three decades culminating in the US-Canada Free Trade Agreement of January 1, 1989; NAFTA became a reality following Canada’s entry in 1991 into the bilateral talks between the US and Mexico, creating the trilateral FTA.

One of the primary objectives of the NAFTA was the elimination of a number of duties and restrictions, which were the stumbling block to free trade between the three neighbors of North America.

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Duties on eligible goods traded among these North American markets are almost reduced or eliminated. NAFTA negotiated and created the Rules of Origin with the purpose of determining the eligibility for favorable treatment under the Agreement. The intention behind the Rules of Origin was to also exclude third countries from obtaining benefits by simply passing goods through North America.

NAFTA’s Rules of Origin are based on the 1988 US-Canada, by which FTA goods generally must undergo sufficient processing within North America if they have to merit a change in tariff classification.

NAFTA has chapters covering a host of aspects of trade, such as:

  • Rules of Origin
  • Protection of intellectual property rights
  • Customs procedures
  • Investment
  • Procedures for dispute settlement
  • Trade in services
  • Agriculture and sanitary and phytosanitary measures
  • Government procurement

Understanding NAFTA is important for businesses in North America and beyond

For businesses in not just North America, but also Asia and Europe, a thorough grasp of the present and emerging NAFTA opportunities and challenges is essential for formulating a sound business strategy. If they have to gain advantage and exploit the huge North American market; they need to be aware of the way the regulations and laws concerning NAFTA operate.

All the aspects of the NAFTA will be explained in detail at a webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance.

The speaker at this webinar is Douglas Cohen, Senior Manager, Global Trade and Contracts at Worldwide Trade and Legal Associates (WWTL), who 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, where he has developed significant expertise in import-export operations and compliance, global transactions, international negotiations, intellectual property, and cross-cultural business communication.

To benefit from the rich experience that Douglas brings into his areas of trade, please register for this webinar by visiting North American Free Trade Agreement (NAFTA)

Full explanation of Rules of Origin and the Certificate of Origin

At this webinar, Douglas will help import-exporters in understanding the NAFTA requirements. This understanding and the way the rules, especially the Rules of Origin, apply will help the participants to take advantage of NAFTA to reduce their costs. The way in which import-exporters classify their potential NAFTA products has major implications for their overall costs of doing business and their profit margin.

Douglas will show how participants can properly complete the NAFTA Certificate of Origin so that they gain advantages such as being able to receive duty free treatment and preventing errors that can result in severe civil/criminal penalties by each countries customs administration. He will also explain how to prepare for a NAFTA audit.

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Douglas will cover the following areas at this webinar, which will be of great benefit to those who currently trade in North America, those considering trading within North America, compliance departments, import-export departments, Trade Consultants, Chambers of Commerce, Business Development Centers, and Foreign Trade Agencies:

  • Fundamentals of NAFTA
  • How do you take advantage of NAFTA to obtain duty free treatment for your NA trade?
  • What is the intent of the NAFTA rules of origin?
  • What is the applicable rule of origin in NAFTA?
  • How do you obtain the certificate of origin?
  • Recordkeeping Requirements
  • Questionnaires, Verifications, Audits

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

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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:

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  • 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.

 

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.

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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.

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  • 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

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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.

How current regulations effect product development strategies

The life sciences market in Japan, consisting of pharmaceuticals, medical devices, biologics and combination products, is huge by the standards of the markets in the neighborhood, such as China, Malaysia, Singapore and Australia. It compares with those of Europe and North America. The main reasons attributed for this are the high spending power of the population, high number and density of the population, the aging population and the huge spending on the healthcare sector on R and D and innovation, which result in high costs that have to be passed on to the consumer.

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At this point of time, Japan is going through developments that have the potential to cause tremors, if not turbulence, in the life sciences market, particularly that of drugs. The annual potential for only drugs is pegged at ¥ 150 billion. In the backdrop of high unit prices of drugs, the government is keen to actively pursue a couple of major initiatives.

One, it wants to cut the price of generics, so that they reach out to a larger market base. Two, it wants to bring about improvements into the regulatory framework by focusing on regulations that ensure higher and easier postmarketing safety. The Japanese regulatory agency, the Pharmaceuticals and Medical Devices Agency (PMDA), is stepping up efforts to make changes into their IT systems, which will streamline the processes for filing clinical data for regulatory approval.

Makeover of its image

The PMDA also plans to recruit more manpower to tighten the overall regulatory process and bolster innovation in this sector to take it to even higher standards than it currently is in. the main purpose for which the PMDA is pushing for all these is to eradicate the impression that has gained ground, especially among western life sciences companies, that Japanese regulatory processes are laggardly and not up to the standards that can be expected from a country of its developmental level.

It is in the backdrop of these contexts that understanding what it takes to make regulatory filings in the life sciences in Japan acquires significance. An in-depth understanding of this topic will be the content of a webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance.

At this webinar, Robert J. Russell, who is President of RJR Consulting, Inc., which assists the pharmaceutical, medical device and biotech industries in understanding and complying with International Regulations affecting compliance, new product development, manufacturing and Quality Assurance, will be the speaker.

To gain insights into how the regulatory filing requirements and compliance processes for Japan work, please enroll for this webinar by visiting http://www.compliance4all.com/control/w_product/~product_id=501369LIVE?Wordpress-SEO

Insights into the regulatory scene

At this session, Robert J. Russell will familiarize participants with the regulatory compliance requirements and procedures for pharmaceuticals, medical devices, biologics and combination products in Japan. He will help participants get an understanding of topics relating to pre-clinical and clinical requirements, as well as with the structure of the regulatory agencies in Japan.

While elaborating on the current regulatory climate in Japan; the speaker will offer examples of effective compliance procedures and techniques. He will describe the methods by which regulators in the corresponding agencies process filings and registrations and what is expected in the authorization and dossier maintenance of licensed products and familiarize participants with a few common issues and concerns that professionals and firms dealing with Life Sciences usually face when they do business with Japan.

Japan’s utilization of the ICH standards

The speaker will also explain how Japan interacts with and utilizes ICH standards. He will also describe how Japan’s way of working with other national regulatory agencies influences their business. The webinar will show ways by which to address the conflicts that sometimes arise and suggest the optimal ways of doing this.

This course will provide insights into all the important areas of regulatory filing requirements and compliance processes for the life sciences in Japan. Its objectives are the following:

  • What is the Regulatory Structure in Japan
  • Understanding the specific procedures for Pharmaceuticals, Medical Devices, Biologics and Combination Products
  • How to begin your company involvement in Japan
  • How current regulations effect product development strategies
  • Pricing issues
  • Understanding the concerns/issues of Japanese Regulatory Personnel
  • Understanding the Local Culture: How to negotiate with the regulators
  • Information necessary for effective submissions
  • Maintenance of Authorized Products

This is the outline for the course:

  • Japan’s Regulatory Structure for the Life Science Product Industries
  • Beginning Your Company Involvement in Japan
  • Life Science Regulations and the Regulatory Processes in Japan
  • Japan’s Use of ICH Standards/Principles
  • Marketing Authorization Processes – Filings & Registrations
  • Variations: Changes to Marketed Products
  • Renewals
  • The Do’s and Don’ts of Regulatory Involvement

Implementing the Final FDA FSMA Rules on the Sanitary Transportation of Human and Animal Foods

The FDA’s Food Safety Modernization Act (FSMA) rule on Sanitary Transportation of Human and Animal Food, which was passed on April 6, 2016, has now become final. This is the latest in a series of as many as seven rules that have been getting legislated from January 2013 with the intention of creating a modern, risk-based framework that ensures food safety.

This Final Rule has, like its predecessors, been created with the goal of preventing practices that create risks in food safety during transportation. Failure in properly refrigerating food, not ensuring sufficient and thorough cleaning of vehicles between loads, and inability to protect food fully and properly are some of these risks and methods. In its efforts at preventing food contamination during transportation, the FDA seeks to enhance its endeavor of protecting foods “from farm to table”.

Takes off from the 2005 Sanitary Food Transportation Act

The foundation to this Rule can be found in the safeguards the FDA envisioned in the 2005 Sanitary Food Transportation Act (SFTA). Following the FDA’s identification of transportation as a major source of food contamination; it has formulated its seven Rules targeting this particular activity. It seeks to address the concerns of contamination during transportation and has brought about this regulation to ensure that foods are safe during transportation.

Towards facilitating this goal; the Final Rule on sanitary transportation of human and animal food establishes sanitary practices requirements which shippers, loaders, carriers by motor or rail vehicle, and receivers involved in transporting human and animal food have to comply with.

Learn the ways of complying with the Final Rule

How do food transporters ensure that they mitigate the risk associated with their business, and how do they comply with this regulation? The ways of doing this will be the learning a webinar from Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will be offering.

This webinar is part of three training sessions that are required for transporters as part of the Final Rule of April 6, 2016. Trainings for the subsequent two sessions will be carried out later. In this session, which is entitled “Responsibilities of the Carrier Under the Final Rules”, John Ryan will cover the training requirements that all carrier personnel engaged in food transportation operations, except those that are exempt, are required to establish. As part of this requirement, they are further required to earn training certificates for the following:

o  Responsibilities of the carrier under the final Sanitary Transportation rules

o  Awareness of potential food safety problems that may occur during food transportation

o  Basic sanitary transportation practices to address those potential problems.

To understand the ways of implementing the Final Rule, please register for this webinar by visiting Final FDA FSMA Rules

Everyone involved in food transportation activities, such as Drivers, Managers, Compliance personnel, Buyers, Supervisors, Internal food safety team members, Maintenance Personnel, Loaders/Unloaders, Inspectors, Trainers and Food Shippers will find this session very useful.

John will cover the following areas at this webinar:

o  Understand US FDA FSMA Law for the Sanitary Transportation of Human and Animal Foods

o  Understand changes from the proposed FDA FSMA rules

o  Know the different requirements for shippers, carriers and receivers

o  Know who is exempted

Understand the FDA waiver requirements.

Meeting equipment validation requirements from the FDA and EU

Putting in place a program for calibrating and maintaining test and measurement equipment is a regulatory requirement from both the FDA, under 21 CFR Part 210 and 211, and relevant EU regulations. Both these agencies have regulations that require this program from manufacturers.

The purpose of this equipment validation program is to ensure these among others:

o  The equipment is reliable and is capable of performing the use to which it is being put

o  It is safe

o  It ensures free flow of work

o  Keeps costs of preparing it down

o  Ensures that the company does not spend too much on premature replacements.

These are some of the ingredients of this program:

o  Intervals

o  Scheduling

o  Specific procedures

o  Limits of accuracy/precision, and

o  Remedial action when the equipment does not meet established requirements.

Main aspects of equipment validation

Equipment validation has to be done from these three perspectives:

o  Installation Qualification (IQ)

o  Operational Qualification (OQ)

o  Performance Qualification (PQ)

o  Change control & Requalification

Validation before and after use

Validation has to be done prior to use. An equipment must be validated to ensure that it the product being produced meets its specifications. In addition, there are ways of validating equipment that are already in use.

A thorough and proper understanding of how to plan and implement a program for the validation and maintenance of test and measurement equipment will be the learning a webinar that is being organized by Compliance4All, a leading provider of professional trainings for all the areas of regulatory compliance, will offer.

This webinar will have Jeff Kasoff, a senior Regulatory Affairs professional, who has more than 30 years in Quality and Regulatory management; as speaker. Jeff brings the rich experience of having implemented and overseen quality system operations and assured compliance, at all sizes of company, from startup to more than $100 million in revenue. To gain the benefit of insightful learning from this highly experienced Regulatory Affairs professional, please register for this webinar by visiting Calibration and Preventive Maintenance

All the aspects of calibrating and maintaining test and measurement equipment

At this webinar, Jeff will give participants an understanding of how to calibrate and maintain test and measurement equipment. He will explain all the elements that go into it, namely intervals, scheduling, specific procedures, limits of accuracy/precision, and remedial action in the event that the equipment does not meet established requirements. In addition, he will also offer an understanding of the various ways by which to validate equipment already in use.

Professionals holding positions in companies, whose work involves equipment/process development, such as QA management, Quality Engineering staff, R&D management, Engineering management, Production management, Manufacturing Engineering staff, Design engineers, Reliability engineers, Calibration technicians, and Maintenance personnel will find this session valuable.

Jeff will cover the following areas at this webinar:

o  Equipment Validation: Installation Qualification, Operation Qualification, and Performance Qualification

o  Preventive Maintenance Requirements

o  Calibration vs. Maintenance: When to use Which One?

o  Remedial Action for Out-of-Calibration Equipment

o  Use of Calibration Standards to Save Cost

o  Equipment Calibration Requirements: Scheduling, Use of External Services, and Documentation.