Regulatory Compliance

DLP is a data security technology that detects and prevents data breach incidents  by monitoring data in-use, in-motion and at-rest.  It has been widely applied for regulatory compliances, data privacy  and intellectual property protection. This talk will introduce basic concepts and security models to describe DLP systems with high level architecture.  DLP is an interesting discipline with content inspection techniques supported by sophisticated algorithms.  Special investigation will be taken for  a few algorithms:  document fingerprinting,  data record fingerprinting, scalable M-pattern string match and etc..

This article examines dynamics of financial surveillance and risk-based regulation in the context of ongoing activities to combat money laundering and terrorist financing. Close analysis of the situation in the UK reveals entangled forms of co-regulation and ultimately co-production of surveillance that challenge ‘institutional boundaries’ of the state regarding policing and intelligence practices. It is argued that ongoing transformations in the anti-money laundering field reveal a dual movement that combines forms of indirect administration with a process of ‘neoliberal bureaucratization’.The article aims to show how current policies against ‘dirty money’ still paradoxically work on the basis of heterogeneous goals and misapprehensions between ‘professionals of security’ and ‘professionals of finance’.

This chapter utilizes a green criminological perspective to examine this key issue as it pertains to waste dumping in rural northwestern China. First, we offer a brief review of green criminology’s approach to waste crime and summarize the literature on top-down environmental regulation enforcement in China. Next, we describe the development of the medical waste regulation framework and highlight the current obstacles to enforcement in China. The chapter then utilizes a case study to illustrate how institutional incentives in the job performance evaluation system of bureaucrats shaped the under-enforcement of medical waste regulations at the grassroots level of rural governance. Our chapter concludes with a discussion of how the study expands our understanding of waste crime and environmental regulation enforcement in an illiberal context.

The study related to pharmaceutical packaging has come to attention for its importance to the quality of drugs and compliance achievement. The aims of this study is to provide a conceptual view of producing a new model of pharmaceutical drug packaging design to overcome existing problems. The proposed methods for this research is to use the process mining techniques to support the construction of a new model for pharmaceutical packaging design process improvement. A case study method was selected for the methodology of the research resulted the flow of packaging design process in pharmaceutical company. The study lengthens the knowledge of drug packaging design process and concludes the importance of drug packaging design process to be investigated for compliance fulfilment purposes. This study is significant to the strong implication of drug quality and safety outcomes for the patients.

В коллективной монографии, посвященной 10-летнему юбилею института оценки регулирующего воздействия в России, анализируется опыт формирования и развития системы публичных обсуждений проектов нормативных правовых актов на наднациональном, федеральном и региональном уровнях. Рассмотрены концептуальные подходы к пониманию сущности регуляторной политики и ее инструментов, выявлены условия эффективного применения на практике правовых средств регуляторной политики, среди которых механизмы оценки регулирующего воздействия, оценки фактического
воздействия и «регуляторная гильотина». В приложении к работе представлен постатейный комментарий к Федеральному закону «Об обязательных требованиях в Российской Федерации».

This article analysis Governments and interest group’s intermediation of employment interest under neo-corporatism to understand young third-country immigrants’ transition to work in  Czech Republic, Hungary, and Poland. Existing research pointed to neo-corporatism that  emphasize large interest group organization cooperates with each other and with public
authorities in interest intermediation to reconcile competing group’s interest with the public,  but the governance leads to inequality. Although neo-corporatism involves regulatory  weakness, there is still little research in Central Eastern European (CEE) countries explaining  Government and interests’ group intermediation of employment interest under neo-corporatism to understand young third-country immigrants’ transition to work. Based on a  qualitative cross-national case-oriented research approach with fewer-country comparison,  documents, published and unpublished scholastic texts are collected and analysed by a  document and content analysis technique to fill in this gap. The findings show that exchange  interaction, industrial restructuring, and compliance monitoring instruments are a major  perceived influence in neo-corporatism governance with a lack of public value accountability  that may impair the reconciliation of social dispute when looking at issues such as young third-country immigrants and socioeconomically disadvantaged groups in interest  intermediation setting. The study demonstrates certain decentralised multilevel corporatist  governance similarities but dissimilarities from the country’s institutional context. The  outcome points to regulatory administrative devices to manage interest group’s crisis and  young vulnerable people’s employment opportunities. This is relevant to bureaucratic  accountability and deliberate democracy, but the risks to democratic deficit, competitiveness,  political inequality, and inefficiency in the complex policy implementation process may  impair ethnic minority people’s belongings, jeopardize public the trust, and hampered open democratic values.

La loi Sapin 2 a introduit un nouveau dispositif anticorruption qui, à l’instar d’autres législations étrangères, valorise la dimension institutionnelle et normative des entreprises afin de garantir une plus efficace prévention et détection des faits de corruption, notamment internationale. L’article analyse les différents volets de ce dispositif en vue d’identifier, au prisme aussi de l’analyse comparée, les garde-fous institutionnels et matériels qui permettraient de garantir un « juste » équilibre entre l’intérêt général de la prévention et de la punition des faits de corruption et les intérêts particuliers qui peuvent être à cette fin stratégiquement sollicités par les pouvoirs publics.

The Sapin 2 law has introduced a new anti-corruption mechanism which, like other foreign legislations, enhances the institutional and normative dimension of companies in order to guarantee a more effective prevention and detection of corruption, especially international corruption. The article analyses the different features of this mechanism in order to identify the institutional and material safeguards that would ensure a "fair" balance between the general interest of prevention and the punishment of corruption and the idiosyncratic interests that may be strategically solicited for this purpose by the public authorities.

Purpose – The paper aims to document the effects of the privatisation of building code enforcement regimes. It notes that privatisation is generally accompanied by trade-offs between competing democratic values such as effectiveness, efficiency, accountability, and equity and explores the extent to which particular trade-offs might be related to aspects of the design of the regimes in which they occur.

Design/methodology/approach – The paper uses a comparative case study analysis of two Australian and two Canadian privatised building control regimes. This comparison is based on semi-structured interviews with key actors in the building and building control industries.

Findings – Evidence of the expected trade-offs between competing democratic values is found in the privatised regimes within the case study. Some of these might be explained in terms of the extent of private sector involvement (PSI) in a regime, or of the nature of the relationship between the public and the private sectors within it. However, not all trade-offs are necessarily related to these characteristics. Overall, PSI deliver an increase in effectiveness and efficiency but at a particular cost of public accountability. A competitive, rather than a complementary, relationship between the private and public sectors in a privatised regime is also found to be more likely to generate problems related to the equity of the service being provided.

Research limitations/implications – The case studies are explorative in nature and the research does not therefore claim empirical generalization, but instead provides illustrations of the impacts that might result from privatising building code enforcement. The paper is largely based on a series of interviews. The findings should be understood as the aggregated opinions of the interviewees.

Practical implications – Based on the case study analysis, the paper draws important conclusions for policymakers in this area. It suggests that privatisation should be performed with the utmost care and highlights positive features of the regimes studied that might indicate some of the ingredients of a successful privatisation. These include providing private sector inspectors with the opportunity to specialize, confining PSI to assessment tasks, and ensuring that a complementary relationship exists between the private and public sectors within the privatised regime.

Originality/value – The paper makes original contributes to existing literature on the impact of the “policy mix” on regulatory governance, and on the trade-offs which result from the introduction of the private sector into regulatory governance.

Overview:

Failure mode and effects analysis (FMEA) is one method hospitals can use to comply with the requirement by the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) that they conduct at least one proactive risk assessment of a high-risk process each year.While it is not the only means of satisfying the requirement,Failure Mode Effect Analysis is used to assess the efficacy and efficiency of medical devices.

Why Should You Attend:

FMEA is an established and widely used procedure in almost all industries including healthcare. FMEA is not, however, a simple procedure.It is of immense use for the high-risk processes such as programming infusion pumps for intravenous delivery of medications, surgical robots, diagnosing a disease, and performing ER interventions. The entire team has to grasp the fundamentals from start to finish because a cross-functional brainstorming is a requirement.

Areas Covered in the Session:

The Joint Commission regulations
FMEA process
Preparation for FMEA
Variations in FMEAs
Team selection and guidance
Improving team efficiency
Identifying failure modes
Identifying system-wide causes
Severity rating
Frequency rating
Detection rating
Risk mitigation
FMEA verification
FMEA procedure at VA hospitals
Examples at other hospitals

Learning Objectives:

Learn to eliminate and minimize risks
Understand the principles of designing a robust process for patient care
Learn to simplify and standardize a procedure
Learn how to prevent harm to patients

Who Will Benefit:

Senior management
All doctors
All nurses
Quality assurance staff
Patient safety staff
Risk managers
Hospital administrators

Level:

Beginner


For more detail please click on this below link:
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Tel: +1-516-900-5515

The aim of this paper is to provide insight into the regulatory landscape surrounding much criticized regulatory reporting and know your customer (KYC) requirements for financial institutions and to describe how regulatory technology can be used for improvement. In terms of potential cost reduction, efficiency gains, and customer satisfaction , significant benefits are to be expected from (regulatory) technology in this domain. Additional factors that will shape the future financial environment are taken into account. First a general summary of upcoming regulation, regulatory technology, blockchain, and KYC are outlined. Subsequently blockchain application in the field of KYC is explained, including an overview of the major benefits and related challenges. Introduction The backlash of the 2008 financial crisis and new technology are the main drivers that have given shape to the new paradigm in the financial industry. Regulators maintain record-low interest rates while establishing a firm legal grip on financial institutions. On top of this, technological innovations lead to changed demands and new forms of competition. Recently FINTECH (financial technology) companies , whose business model revolves around providing automated alternatives to mainstream banking products , have received much attention. 1 With their offer they appeal to the younger generation (millennials) of customers that demands quick, digital, and personal-ized service. Surveys confirm that this generation has a

Para hablar de medicamento debemos establecer su definición como "toda preparación o producto farmacéutico empleado para la prevención, diagnóstico y/o tratamiento de una enfermedad o estado patológico, o para modificar sistemas fisiológicos en beneficio de la persona a quien se le administra". Igualmente hay que definir el concepto de principio activo, que es toda sustancia química o mezcla de sustancias relacionadas, de origen natural o sintético, que poseyendo un efecto farmacológico específico, se emplee en medicina humana. Al hablar de nombre genérico, nos referimos a la denominación de un principio activo o, cuando corresponda, de una combinación de principios activos a dosis fijas, adoptada por una Autoridad Sanitaria nacional o, en su defecto, la Denominación Común Internacional, de un principio activo recomendada por la Organización Mundial de la Salud. El concepto de biodisponibilidad nos remite a la velocidad y magnitud en que un principio activo se absorbe a partir de una forma farmacéutica y queda disponible en el lugar de acción, aceptándose las concentraciones sanguíneas detectables como representativas de concentración en el lugar de acción. Finalmente, una especialidad farmacéutica será todo medicamento, designado por un nombre convencional, sea o no una marca comercial, o por el nombre genérico que corresponda a su composición y contenido, preparado y envasado uniformemente para su distribución y expendio, de composición 1

219/2006 -Attuazione della direttiva 2001/83/CE relativa ad un codice comunitario concernente i medicinali per uso umano, nonché della direttiva 2003/94/CE Art. 113 -Definizione di pubblicità dei medicinali e ambito di applicazione Per «pubblicità dei medicinali» si intende: qualsiasi azione d'informazione, di ricerca della clientela o di esortazione, intesa a promuovere la prescrizione, la fornitura, la vendita o il consumo di medicinali. La «pubblicità dei medicinali» comprende: a) la pubblicità dei medicinali presso il pubblico; b) la pubblicità dei medicinali presso persone autorizzate a prescriverli o a dispensarli, tra cui: la visita di informatori scientifici presso persone autorizzate a prescrivere o a fornire Medicinali.

O presente artigo tem por objetivo analisar a responsabilidade dos administradores das companhias abertas pela implantação e manutenção de programas de compliance, à luz das novas regras estabelecidas na recém-publicada Lei 12.846/2013, a que alguns vêm chamando de Lei Anticorrupção.

SUMARIO: 1. INSPECCIÓN ADMINISTRATIVA Y MEDIO AMBIENTE. 2. AUTORREGU-LACIÓN Y MEDIO AMBIENTE. 3. CONTRATACIÓN PÚBLICA Y MEDIO AMBIENTE.4. CONTRATACIÓN PÚBLICA Y COMPLIANCE. 4.1. Antecedentes. 4.2. La incorporación del compliance a la legislación europea en materia de contratación pública. 4.3. La incorporación del compliance a la legislación española en materia de contratación pública. 5. LA PROYECCIÓN DEL COMPLIANCE EN EL ÁMBITO DE LA CONTRATACIÓN PÚBLICA SOSTENIBLE. 6. CONCLUSIONES. 7. BIBLIOGRAFÍA. 1. INSPECCIÓN ADMINISTRATIVA Y MEDIO AMBIENTE

Imagine a situação. De um dia para o outro você descobre que, a partir daquele momento, será o responsável pela área de Compliance da sua empresa, com a necessidade de implementar o programa para ontem. Ou, insatisfeito com sua atividade profissional, resolve empreender uma transição de carreira e descobre no Compliance uma excelente oportunidade, mas não sabe, ao certo, por onde começar. Pode parecer uma situação surreal ou desesperadora, não importa. A verdade é que essa é uma realidade cada vez mais presente no ambiente corporativo brasileiro, que aflige desde diretores experientes de áreas já estabelecidas, como Jurídico ou Finanças, até jovens profissionais que acabaram de fazer um curso e tem uma boa base teórica, mas...
Compliance é uma atividade prática!
Claro, é importante conhecer legislações locais e internacionais pertinentes, metodologias de avaliação de risco, de implementação de controles, de investigações internas, etc. Entretanto, todo esse cabedal teórico, por si só, não vai ajudar na sua missão mais importante naquele momento, diante do que a empresa em que trabalha ou cliente contratado realmente esperam de você: implementar o bendito Programa de Compliance.
Não é uma tarefa fácil, nem simples. Mas, existem ferramentas que podem ajudar profissionais sem grande vivência na área a executar essa missão de forma mais rápida e objetiva. E dentre essas ferramentas, este Manual de Compliance é, muito provavelmente, uma das mais simples, práticas e acessíveis.
O Manual de Compliance foi escrito pelos participantes do Compliance Mastermind – programa de afiliação anual da LEC para profissionais de Compliance em posição de gestão. Isso dá a esta obra, a experiência de décadas e décadas, obtida por quem atua tanto dentro de empresas, como em consultorias, trazendo um olhar amplo, mas sempre a partir de uma abordagem real do funcionamento da área.

The integration of governance, risk, and compliance (GRC) activities has gained importance over the last years. This paper presents an analysis of the GRC integration efforts in information technology departments of three large enterprises. Action design research is used to organize the research in order to assess IT GRC activities based on a model with five dimensions. By means of semi-structured interviews key findings concerning the status quo of the three IT GRC disciplines, their integration and their relation to GRC on the corporate level are identified and rated. Five key findings explain the main commonalities and differences observed.

The proliferation of Internet and virtual communities led to the creation and continuous increase of circulation of virtual currency schemes. The virtual currency that has seen enormous growth both in value and public perception to date is the Bitcoin scheme which is based on a pioneering technology: the decentralised ‘blockchain’ technology. Bitcoin does not have any physical counterpart with legal tender status and there is no involvement or supervision by central banks or any other authorities in the process. Hence, its fundamental features in the context of cryptocurrency could be considered both beneficial and disadvantageous. However, the risks to which users, central banks and whole economies are exposed, might be mitigated whether Bitcoin scheme would be regulated. While the question of a potential regime for this type of virtual currencies arises, several national authorities, the European Central Bank and international fora express their major interest pertaining to the issue. Although Bitcoin’s future role as a currency is a completely hypothetical matter, its technology could transform law not only in terms of new legislation, but also in terms of practice.

The review explores the regulatory framework governing heavy vehicle road transport in Australia and explores the motivations behind non compliance with the law. It evaluates the effectiveness of the existing regulatory tools to respond to the different reasons for non compliance.

Artificial intelligence, blockchain and other potentially disruptive technologies form the crucial innovation, structural and institutional foundation for not only economic development, but also moral development and practical ethics. The integration of blockchain and AI [artificial intelligence] into a decentralized intelligence system has profound possibilities to employ data in innovative ways. An effective amalgamation of both technologies with IoT [internet of things] devices will enable faster and seamless data management, validation of transactions and detection of illegal activities, among others.

Four traditional criminological theories--opportunity, control,  subcul­tural, and differential association--are tested for their explanatory power in accounting for organizational compliance with regulatory laws. The primary data source is interviews with 410 chief executives of small orga­nizations. Partial support is found for each theory; certain key concepts of each theory have a significant effect on regulatory compliance, net of a variety of characteristics of the nursing home, the residents in the home, and the inspection team. The results show that blocked legitimate oppor­ tunity has a significant effect on regulatory compliance, as does the struc­ ture of illegitimate opportunity. There is also an effect on compliance of participation in business subcultures of resistance to regulation. Belief in laws increases compliance with those laws as does differential association with or attachment to the upholders of the law. Overall, however, control theory and differential association lack explanatory power, and the explanatory power of subcultural theory is modest. Only opportunity the­ ory explains a credible proportion of variance in compliance as a stand­ alone theory. The significant effect of some but not all of the measures for each theory, coupled with the lack of significant explanatory power by three of the four theories, suggests the need for theoretical integration.

RESUMO:
O presente capítulo possui, como pano de fundo, o (crítico) modo com o qual as SPEs instituídas para parcerias público-privadas estão lidando com as temáticas relacionadas ao compliance. Diante desse cenário, destaca, por meio de apontamentos, problematizações práticas e recomendações, a imprescindível – e assaz desafiadora – necessidade de implementação, por tais empresas, de programas de integridade customizados e realmente atentos às inúmeras e significativas particularidades inerentes aos contextos que se inserem, às atividades que desempenham e ao estreito relacionamento que possuem com agentes públicos do Poder Concedente. Um manifesto pela contra a descrença e o descaso.

SUMÁRIO:
1. Relevância do tema e dos objetivos deste artigo;
2. Demais premissas deste artigo;
2.1. Premissas históricas: brevíssimo resumo da interseção temática;
2.1.1. As parcerias público-privadas no Brasil: informações pontuais pertinentes ao tema deste artigo;
2.1.2. Os programas de integridade no Brasil e sua interseção e relacionamento com as PPPs;
2.2. Premissa Hermenêutica: o serviço público desempenhado como fator de distinção;
3. Dificuldades e problemas específicos do compliance em PPPs;
3.1. Preocupações e dificuldades contextuais específicas: aprofundamento e compreensão inicial das características da PPP;
3.1.1. Contexto externo: conhecimentos e apontamentos pertinentes à toda PPP;
3.1.2. Contexto interno: a ser mais detalhado e dificultoso do que mera radiografia;
3.1.3. Contexto orbitante específico: aspectos subjetivos e contratuais que se relacionam direta ou indiretamente com a PPP;
3.2. Problemas materiais específicos: reflexões e questionamentos sobre particularidades a serem diretamente enfrentadas pelo compliance da PPP;
3.2.1. O compliance e o PMI: os encontros e o tratamento das informações;
3.2.2. As audiências públicas sobre o conteúdo editalício;
3.2.3. Desapropriações, desocupações e necessárias prevenções;
3.2.4. As (sempre delicadas e complexas) especificidades remuneratórias: problemas a serem enfrentados pelo programa de integridade;
3.2.5. A possível interdependência entre serviços da PPP e do Poder Concedente: problemas – e limitações – para o compliance;
3.3. O grave problema sobre os responsáveis pela gestão do compliance nas SPEs de PPPs: o imperialismo e/ou ateísmo e/ou o preguicionismo gerando – ou garantindo – a inefetividade do programa de integridade;
4. Conclusão: o conflito de interesses e a transparência proativa como calcanhares de Aquiles dos compliance em PPPs;
5. Referências bibliográficas.

El presente artículo trata sobre la más reciente norma de
combate de la corrupción en Brasil, la Ley 12.846, de 2013
– que pasó a ser llamada de “Ley Anticorrupción Empresarial”.
De forma novedosa, la norma bajo examen trajo para
el ordenamiento jurídico patrio un conjunto de medidas
preventivas y represivas de combate de la corrupción, ante
las personas jurídicas. El artículo busca describir sus principales
puntos de interés, como también analizar los problemas
inherentes a la falta de regulación del procedimiento administrativo,
a la ausencia de criterios para la aplicación de las
sanciones, como también de las circunstancias atenuantes y
la naturaleza de la responsabilidad objetiva. Ante dicha problemática,
el texto tiene como objetivo elaborar un estudio
sobre la cuestión de la descentralización de la conducción
de los procedimientos administrativos. Por fin, se debate la
regulación de los programas de compliance.

The UAE enjoys political stability, liberal business environment and robust economic development.  It has a very thriving real estate market and it houses a world class financial services hub that sits in Dubai known as the Dubai International Financial Center - DIFC.  The UAE is also a hub for trading gold, diamonds, precious metals, arts and much more.  With this significant business and economic status that the UAE has acquired that makes it a vital center for trade, financial activity and transportation, it naturally attracts monies from all around the world and as a result, this leaves the country vulnerable to criminal financial activities.  There is also the particular geographic location and the implications of business linkages with high risk and less stable neighboring countries that the UAE has an open and free trade market with.  No wonder, the UAE has very peculiar and particular dynamics and consequently, the UAE is also vulnerable to trade based money laundering activities - TBML through trading companies that have activities with sanctioned countries or through commodities used as counter valuation in hawala transactions. Evidently, there is a strong correlation between the dynamics mentioned above to the fact that the UAE appeals to criminals that are keen to use its financial system for financial crime activities. 
The Financial Action Task Force - FATF and other international bodies that are dedicated to protecting the global financial system from ML and TF activities place Customer Due Diligence - CDD at the heart of an effective AML/CFT framework.  As such, the most important focus needs to be put on CDD measures and practices which are the primary and most critical part of any compliance program which is intended to ensure that financial institutions - FIs know the person on whose behalf they are holding funds for or conducting transactions for and to identify any potential risk that he/she may pose.  An effective CDD undertaking requires identifying and verifying the customer and the beneficial owner(s), understanding and collecting the required information on the purpose and the intended nature of the business relationship, validating the source of wealth as well as maintaining an ongoing monitoring of the business relationship.
The UAE invested significantly in improving its regulatory structure and made immense progress by putting the appropriate legal framework. Suitably, complying with regulatory requirements is a key focus for FIs in the UAE.  And yet, despite the good legislative system that is now available and the satisfactory practices by FIs, there still remains some UAE specific challenges that make it, at times, more difficult to undertake CDD for certain customers.  Challenges include complications in identifying the beneficial owners, impediments in establishing the source of wealth, concerns with politically exposed persons - PEPs, derisking and others.
This study is qualitative in nature.  The purpose of this paper is to unpack the CDD vulnerabilities and to examine and analyze the UAE specific dynamics that make the country exposed to these threats.  This research also intends to put on the table suitable solutions and remedial action steps that the UAE government, regulators and FIs can adopt. 
The international bodies whose mandate is to formulate the necessary AML/CFT policies and regulations for global implementation together with ACAMS have published sufficient studies on CDD related issues in the UAE. Yet on the other hand, very limited literature was found by independent scholars.  This paper will therefore largely reference publications by FATF, the INCSR and ACAMS.  It will also include works by respected law firms that have operations in the UAE, local publications, government documents, academic papers by the IMF and the World Bank, legal journals and others.  This research will also delve into other publications that are not necessarily UAE specific but which will rather provide insightful thoughts, considerations and add further in-depth understanding of CDD related problems that the UAE can relate to and yield possible solutions for the local regulators and FIs to consider. Publications include academic papers by esteemed scholars, legal journals, industry specific magazines and others.

Overview:

In the evaluation of risk in support of safety management systems decision making models can be applied. There is a need to evaluate complex risks by integrating many factors and applying considerations in a logistical and consistent way. This presentation presents a basic decision analysis method that can enable the evaluation and integration of complex risks within any system. At the conclusion of the discussion additional decision analysis methods will be highlighted.

Why Should You Attend:

Various safety professionals that are interested in applying decision analysis methods in solving safety-related problems; including implementing various methods in support of risk management; such professionals as: risk managers, safety directors and managers, safety engineers, compliance engineers, and risk analysts.

Areas Covered in the Session:

Formal methods are applied in system management to aid in safety-related decision-making. This field of work is referred to decision theory or decision analysis. The techniques are used to determine optimal strategies when a decision-maker is faced with several decision alternatives and uncertain or risky future events. The application of decision analysis is extensive and approaches vary from the construction of tables, decision trees, and to the use of extensive decision analysis within computer applications and modeling.

Learning Objectives:

Participants will gain an understanding for
Decision analysis methods and how these methods are applied within safety management system.
A basic decision analysis method is discussed in a context of solving operational-related problems associated with changes in systems.
To accomplish integration decision analysis matrix will be shown and discussed.
A review of appropriate decision analysis tools will be presented.

Who Will Benefit:

Anyone interested is applying decision analysis to solve safety-related problems in support of risk management.

Level:

Intermediate

For more detail please click on this below link:
https://www.complianceglobal.us/product/700036
Email: [email protected]
Toll Free: +1-844-746-4244
Tel: +1-516-900-5515

The new EU General Data Protection Regulation (GDPR) establishes requirements (and certain incentives) for internal compliance mechanisms that do not exist in current legislation. These requirements, which will have an impact on internal processes and staffing of firms, such as the requirement in certain cases of engaging a data protection officer, of conducting a data protection impact assessment, or making notifications of data breaches, will require firms to organize themselves prior to the GDPR becoming applicable in 2018. This article sets out first the increased territorial scope of the GDPR, prior to discussing the increased accountability of firms, focusing on data protection impact assessments, prior consultation and prior authorization, data protection officers, and data breach notifications. On the way, certain differences among the various versions of the GDPR prior to its adoption on these points will be discussed. Finally, incentives for compliance are highlighted. Résumé Le nouveau règlement général sur la protection des données dans l'UE (RGPD) fait naître des obligations et comprend des incitatifs liés à l'élaboration de mécanismes internes de conformité qui n'existent pas dans la législation actuelle. Ces obligations, telles que celles, dans certains cas, de désigner un délégué à la protection des données, de mener une analyse d'impact relative à la protection des données ou d'effectuer une notification d'une violation des données à caractère personnel, auront un impact sur les processus internes ainsi que sur l'organisation du personnel des entreprises. Ainsi, elles obligeront ces dernières à revoir leurs manières de faire d'ici la date de la mise en application du RGPD en 2018. Cet article expose d'abord le champ d'application territorial accru du RGPD, avant de discuter de la responsabilisation augmentée des entreprises et plus précisément des analyses d'impact relatives à la protection des données, de la consultation et de l'autorisation préalables, des délégués à la protection des données et des notifications d'une violation des données à caractère personnel. Ce faisant, certaines divergences entre les différentes versions préliminaires du RGPD sur ces points seront évoquées. Enfin, certains éléments qui inciteront les entreprises à se mettre en conformité avec le RGPD seront soulignés.

This final formatted copy of the article was first published in 50 (3) Revue juridique Thémis de l'Université de Montréal (RJTUM) 783-820 and is available on the journal's website at https://ssl.editionsthemis.com/revue/article-4951-internal-compliance-mechanisms-for-firms-in-the-eu-general-data-protection-regulation.html.

Overview:

All life science businesses are required to maintain their Quality Management System (QMS) processes in a state of control, via controlled documents and objective evidence in the form of records.

Medical device manufacturing plants, required to follow 21 CFR Part 820, have the additional responsibility to ensure that each and every step of the manufacturing process is controlled by work instructions, SOPs, set-up instructions, equipment maintenance, and support functions, and that evidence of this work is maintained by controlled records.

Prior to computer systems and databases, managers and quality personnel created complex visual numbering schemes, cross-referencing methods and complex filing systems for purposes of retrieval and control.  These grew over the years into the extremely complex and convoluted systems we find today throughout the life sciences, including the medical device industry.

As is often the case, automation and computers do not always replace the legacy methods, policies, and rules that were necessary with manual and paper systems but are now obsolete.

Unfortunately, that is the case in the overwhelming majority of medical device companies.  The benefits of automation and information retrieval systems are not fully realized due to the legacy policy constraints that still hamper them.

In this webinar, we apply the Theory of Lean process improvement and its corollary Theory of Lean Configuration to present a fresh approach to following 21 CFR Part 820.

Why Should You Attend:

If you are constantly struggling to create, manage, and maintain all of the information found in controlled documents, all of which are often redundant, repetitive, and clustered together in an awkward manner, this webinar is something that will give you a different perspective and a very different approach that you can use.

If your design and manufacturing resources are spending too much time on documentation and not enough time on actual design and manufacturing you as a manager need to be looking for ways to simplify their work.

This webinar presents a new approach yet is based on solid principles and proven practices.

Areas Covered in the Session:

• Brief introduction to Lean Documents and Lean methodology
• Quality Management System, 21 CFR Part 820, and ISO 13485 as these apply to design control documents
• Basic functions found in a life sciences manufacturing plant
• Key types of controlled documents and records for manufacturing
• Quality Management System (QMS) elements controlled via documentation
• Bringing it all together

Learning Objectives:

If you are constantly struggling to create, manage, and maintain all of the information found in controlled documents, all of which are often redundant, repetitive, and clustered together in an awkward manner, this webinar is something that will give you a different perspective and a very different approach that you can use.

If your design and manufacturing resources are spending too much time on documentation and not enough time on actual design and manufacturing you as a manager need to be looking for ways to simplify their work.

This webinar presents a new approach yet is based on solid principles and proven practices.

Who Will Benefit:

Managers, Supervisors, Directors, and Vice-Presidents in the areas of:
• R&D
• Manufacturing Engineering
• Design Assurance
• Quality Assurance
• Operations
• Document Control

Level:

Intermediate

For more detail please click on this below link:

https://www.complianceglobal.us/product/700027

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