This document discusses challenges and methods for standardized legal compliance management in electronics production. It provides the following key points:
- Legal frameworks governing substance usage in electronics have become increasingly complex, creating challenges for companies. Standardization of reporting and data exchange is needed.
- Relevant regulations including REACH, RoHS, and TSCA are outlined. Standards like IPC-175x and IEC-62474 have emerged to help standardize material declarations and data exchange.
- A software-based compliance management system called iPoint Compliance Agent is introduced. It allows automated data collection, checks, integration with other systems, and report generation to help streamline the compliance process.
Pyxa Solutions is comprised of a dynamic team of management consultants and R&D subject matter experts specializing in cross-functional R&D delivery stemming from activities led by Regulatory Affairs.
Pyxa was founded in 2012 to provide our clients a refreshing consulting experience, through engagement with experienced industry leaders and consultants by delivery of high-quality deliverables and unique services. Pyxa is managed by a team of three seasoned partners with prior blended expertise in industry and management consulting.
Transitioning from paper to eCTD for 2253 Submissions?
The updated 2253 draft guidelines for Ad Promo submissions, is an example of the FDA encouraging sponsors to adopt practices that will benefit industry as a whole.
A step in the right direction.
Submitting video, audio and images as DVD media by mail in an age of such impressive computing power at low cost is much too tedious for sponsor and Agency.
Modernization.
By updating the specification, updating the technology, and encouraging a rethinking of internal processes, the FDA is moving toward a more modern business reality.
This webinar discusses automating product compliance processes using Zero Wait-State's LoadState tool and process extensions. It begins with an overview of obtaining compliance data from part research vendors or directly from suppliers. While vendors provide consistent high-quality data, it can be costly, and specialized parts may not be supported. Requesting data directly from suppliers is cheaper but slower and less consistent.
The presentation then demonstrates LoadState, which can import supplier data, perform validations, and populate declarations. Process extensions are highlighted that can assign specifications to bills of materials, download compliance data in batches, generate request for information processes, and create enhanced compliance reports. The webinar concludes with announcing an upcoming webinar on regulatory changes
Chemical Watch Chemicals Management for Electronics Europe 2020: IPC Data Exc...raj takhar
Presentation on the IPC Data Exchange Standards from a European participation perspective.
Details of the conference can be found here: https://events.chemicalwatch.com/84141/chemicals-management-for-electronics-europe-2020/programme/?dayID=114435
SAP Sapphire 2019: WEEE- SAP Recycling AdministrationVedant Borse
This document summarizes a presentation on the WEEE Directive for electrical waste compliance in Europe. The new directive expands the scope of covered products and replaces the 10 categories with 6 new categories effective August 2018. It will require producers to correctly classify their electrical products and report them to compliance schemes in European countries. SAP REA (Recycling Administration) was presented as a software solution to help companies like Agilent Technologies comply with the new directive through an integrated SAP system for recycling declarations, fee calculation, and reporting across regulations globally. Benefits of SAP REA include single system for WEEE declarations, master data management for regulations, and addressing multiple recycling compliance schemes.
Presentation with Monika Srubarova from 1CC regarding the current status of ECHA SCIP, reviewing duty holder obligations, legal entities, different types of SCIP notification types, simple / complex article reporting and choosing the correct approach for data transmission (manual vs automated).
Pyxa Solutions is comprised of a dynamic team of management consultants and R&D subject matter experts specializing in cross-functional R&D delivery stemming from activities led by Regulatory Affairs.
Pyxa was founded in 2012 to provide our clients a refreshing consulting experience, through engagement with experienced industry leaders and consultants by delivery of high-quality deliverables and unique services. Pyxa is managed by a team of three seasoned partners with prior blended expertise in industry and management consulting.
Transitioning from paper to eCTD for 2253 Submissions?
The updated 2253 draft guidelines for Ad Promo submissions, is an example of the FDA encouraging sponsors to adopt practices that will benefit industry as a whole.
A step in the right direction.
Submitting video, audio and images as DVD media by mail in an age of such impressive computing power at low cost is much too tedious for sponsor and Agency.
Modernization.
By updating the specification, updating the technology, and encouraging a rethinking of internal processes, the FDA is moving toward a more modern business reality.
This webinar discusses automating product compliance processes using Zero Wait-State's LoadState tool and process extensions. It begins with an overview of obtaining compliance data from part research vendors or directly from suppliers. While vendors provide consistent high-quality data, it can be costly, and specialized parts may not be supported. Requesting data directly from suppliers is cheaper but slower and less consistent.
The presentation then demonstrates LoadState, which can import supplier data, perform validations, and populate declarations. Process extensions are highlighted that can assign specifications to bills of materials, download compliance data in batches, generate request for information processes, and create enhanced compliance reports. The webinar concludes with announcing an upcoming webinar on regulatory changes
Chemical Watch Chemicals Management for Electronics Europe 2020: IPC Data Exc...raj takhar
Presentation on the IPC Data Exchange Standards from a European participation perspective.
Details of the conference can be found here: https://events.chemicalwatch.com/84141/chemicals-management-for-electronics-europe-2020/programme/?dayID=114435
SAP Sapphire 2019: WEEE- SAP Recycling AdministrationVedant Borse
This document summarizes a presentation on the WEEE Directive for electrical waste compliance in Europe. The new directive expands the scope of covered products and replaces the 10 categories with 6 new categories effective August 2018. It will require producers to correctly classify their electrical products and report them to compliance schemes in European countries. SAP REA (Recycling Administration) was presented as a software solution to help companies like Agilent Technologies comply with the new directive through an integrated SAP system for recycling declarations, fee calculation, and reporting across regulations globally. Benefits of SAP REA include single system for WEEE declarations, master data management for regulations, and addressing multiple recycling compliance schemes.
Presentation with Monika Srubarova from 1CC regarding the current status of ECHA SCIP, reviewing duty holder obligations, legal entities, different types of SCIP notification types, simple / complex article reporting and choosing the correct approach for data transmission (manual vs automated).
The document discusses challenges related to IDMP compliance, including information stored across different systems and formats, duplication of data, lack of integration between processes. It then outlines potential solutions to these challenges like entity extraction to transform unstructured data, master data management to connect siloed structured data, reference data management to handle semantic issues, and linked data approaches to publish structured, interconnected data using common standards and identifiers. The value of these solutions beyond mere compliance is also discussed in terms of transparency, risk reduction, efficiency and collaboration.
Pistoia Alliance Debates: IDMP: It’s all about the patient: enhancing patient...Pistoia Alliance
This webinar discusses IDMP (Identification of Medicinal Products) and focuses on substances and their implementation. It provides background on IDMP, timelines for implementation in the EU which is driving standardization, and an example substance record for Brentuximab Vedotin to illustrate the level of detail in substance definitions. The goal of IDMP is to improve patient safety through standardized identification and exchange of information on medicines and ingredients.
Chemical Watch Chemicals Management for Electronics USA 2020: Updates on Chem...raj takhar
Presented at the Chemical Watch Electronics USA 2020 conference.
This conference presentation covered emerging EU Chemical Sustainability Standards, based on flow down strategies from the EU Green Deal, with specific reference to the consultations being conducted following the publication of the EU Chemical Sustainability strategy released in October 2020.
Details of the conference can be found here: https://events.chemicalwatch.com/88945/chemicals-management-for-electronics-usa-2020
IERC 2015 Sustaining the US Electronics Recycling Market SalzburgEric Harris
The document discusses challenges facing the US electronics recycling industry, including producer responsibility laws, export regulations, and definitions of waste versus non-waste goods. It notes that over 80% of electronics are recycled domestically rather than exported. Third-party certification standards are growing to ensure environmentally sound recycling globally. Partnerships between recyclers help address large volumes of residential waste and challenges in commodities like CRT glass. A competitive circular economy requires global cooperation and competition between responsible recyclers.
Data Integrity; Ensuring GMP Six Systems Compliance Pharma TrainingMarcep Inc.
This document outlines a two-day workshop on data integrity compliance to meet regulatory standards. The workshop will cover data integrity requirements from the FDA, EU, and other regulators; challenges in ensuring data integrity across paper, hybrid, and electronic systems; best practices for data generation, recording, transformation and reporting; and conducting risk assessments and monitoring metrics to ensure ongoing data integrity. Attendees will learn how to strengthen internal audits and compliance across their quality systems, facilities, materials management, and other areas to meet data integrity expectations.
Counting for Large Property Portfolios | Sean Lockie icarb
The document summarizes presentations given at the Westminster Carbon counting conference in 2008. It discusses the need for standards in carbon accounting, presents three case studies of carbon accounting projects, and describes Atkins' development of a carbon manual to standardize their carbon services.
Maintaining A Materials Declaration Systemraj takhar
This document outlines topics for developing a material declaration management process, including: defining internal data flows; cleaning supplier and internal data; methods for exchanging declaration data; determining whether to outsource declaration processing; risk mitigation strategies; and collecting positive declarations from suppliers. It provides guidance on mapping article and supplier data, transmitting declaration requests, tracking responses, analyzing collected data, and engaging with suppliers.
This document summarizes a webinar on validating material information and collecting material analysis data. It discusses how material assay testing can provide valuable information about a product's material composition when combined with an electronic data management system. Material assay testing involves breaking products down into homogeneous materials and testing them to identify substances present. Challenges like ensuring data validity, completeness, and traceability over time can be addressed by linking material assay test reports to an electronic database system. This allows dynamic data updates and sharing of information with customers and suppliers in a standardized format.
Electronic chemicals and materials are used in the manufacturing of various electronic devices such as semiconductors, integrated circuits, and flat panel displays. These chemicals require advanced purification technologies to provide consistently low contaminant levels for processes like semiconductor manufacturing. Some examples of electronic chemicals include acids, electroplating solutions, etchants, fluorides, gases, pure elements, and semiconductor grade chemicals. The market for electronic chemicals and materials is projected to grow at a 7.7% compound annual rate from 2019 to 2024.
This document discusses the challenges of efficient data management for sustainable product design. It notes that legal frameworks like RoHS, REACH, and WEEE place huge demands on companies' data management systems. Existing systems for managing this data have limitations, including lack of integration between systems, uncertainty over data security, and dependence on externally controlled systems. The paper then presents a new solution called the iPoint Compliance Agent that aims to address these issues by enabling the automated exchange and integration of data across a company's internal systems and external sources to facilitate compliance checks throughout the supply chain.
The document discusses new mortgage disclosure requirements under TILA-RESPA that will take effect on August 1st. The new requirements consolidate four previous disclosures into two new forms: the Loan Estimate and Closing Disclosure. While the new disclosures are intended to be easier for consumers to understand, they present difficulties for lenders who must now use two separate systems to comply with the new rules or the previous rules depending on the type of mortgage. The new requirements will also require lenders and settlement companies to cooperate earlier in the process when providing the Closing Disclosure.
The document discusses photo backgrounds and props chosen for a college magazine to appeal to its target audience of college students. Lockers, a brick wall, stairs, papers, folders, IDs, and friends are included to represent common college experiences. One photo is rejected due to bright sun causing closed eyes. Revisions include using props to show old and new revision methods using paper and phone.
Bilcare_GCS Quality and Regulatory OveriewBilcare GCS
Bilcare is committed to providing innovative clinical trial material supply services globally according to quality and regulatory standards. It offers services including clinical trial manufacturing, packaging, labeling, sourcing of drugs, and storage and distribution. Bilcare aims to provide cost-effective and creative solutions through strategic partnerships to help customers succeed. It focuses on customer satisfaction, continual self-improvement, and compliance with regulations like cGMP, GCP, and ISO 9001. Bilcare works to improve through learning from audits and implementing systems improvements.
Jonathan Bennett has over 15 years of experience as a project manager in various industries. He is currently a senior project manager at Ellucian, where he manages the implementation of student management systems across multiple clients. Previously, he has held project management roles at The Collinson Group and The Chartered Insurance Institute. He has a BSc in Engineering with Business Studies and is a certified Project Management Professional with Prince2 qualifications.
An advertising campaign involves a series of coordinated messages over time that are centered around a consistent theme. This theme guides individual ads and marketing communications and determines the campaign's tone. Advertising campaigns can target local markets, entire regions, or be national in scope. Developing an effective campaign requires identifying the problem, setting a budget, pre-testing concepts, understanding the target audience, selecting appropriate media outlets, crafting compelling language and visuals, establishing the timing and duration, post-testing performance, and evaluating the impact on sales.
Bilcare GCS provides comparator drug procurement services for global clinical trials. It has expertise sourcing drugs worldwide and providing the necessary documentation and logistics to meet regulatory requirements. Bilcare can source drugs in large volumes and multiple batches with long expiration dates. It aims to provide authentic products, full traceability, and guidance to sponsors to enable cost savings. Bilcare has extensive experience procuring various drug types across multiple countries and regions.
BGCS is a specialist logistics provider for the life sciences sector globally, providing logistics solutions and transport of materials like clinical trial supplies, diagnostic materials, medical devices, and stem cells. It has a strong network of depot offices globally and in Europe to provide door-to-door shipments that are closely monitored. BGCS has experience handling dangerous goods across a range of temperatures. It aims to provide guaranteed time definite deliveries through dedicated customer service and real-time shipment information and monitoring.
The document analyzes the financial industry using Porter's five forces model. It finds that the threat of new entrants is low due to the lengthy regulatory approval process required. Rivalry is strong as institutions compete for customers and deposits. The threat of substitutes is high as customers frequently use multiple institutions. Suppliers like the Federal Reserve and credit card companies have significant bargaining power. The bargaining power of buyers is low for commercial banks but higher for credit unions which are member-owned.
This radio program document provides summaries of upcoming art, music, and cultural events in Australia. It discusses the Dark Mofo winter solstice festival in Hobart and an interview with a local artist involved. It also previews a tug-of-war art installation exploring social change in Prague. Additionally, it mentions that musician Antony donated funds from a music festival to an indigenous Australian group threatened by mining, and that a Senate inquiry was called to investigate cuts to federal arts funding.
Some frecuently used US slang and idioms. There are so many it was tough selecting which ones to add. However, I didn't want the ppt. to be overly long either. Enjoy :)
Bilcare GCS provides end-to-end clinical trial material supply chain services including packaging, labeling, storage, distribution, and returns/destruction. It has facilities in India and a global depot network to support clinical trials worldwide. Services include primary and secondary packaging, comparator sourcing, IVRS/IWRS, logistics and supply chain management, and QA/QC through qualified professionals and compliant facilities.
Bilcare GCS Packaging and Labeling CapabilitiesBilcare GCS
Bilcare GCS offers formulation development, clinical manufacturing, packaging, and labeling services to pharmaceutical and consumer healthcare clients. They have experienced scientists and state-of-the-art facilities to efficiently develop innovative formulations. Bilcare aims to help clients overcome challenges and accelerate time to market. Their integrated services allow seamless product development from formulation through clinical trials and commercialization. Bilcare has extensive experience producing various dosage forms and packaging configurations for clinical trials.
The document discusses challenges related to IDMP compliance, including information stored across different systems and formats, duplication of data, lack of integration between processes. It then outlines potential solutions to these challenges like entity extraction to transform unstructured data, master data management to connect siloed structured data, reference data management to handle semantic issues, and linked data approaches to publish structured, interconnected data using common standards and identifiers. The value of these solutions beyond mere compliance is also discussed in terms of transparency, risk reduction, efficiency and collaboration.
Pistoia Alliance Debates: IDMP: It’s all about the patient: enhancing patient...Pistoia Alliance
This webinar discusses IDMP (Identification of Medicinal Products) and focuses on substances and their implementation. It provides background on IDMP, timelines for implementation in the EU which is driving standardization, and an example substance record for Brentuximab Vedotin to illustrate the level of detail in substance definitions. The goal of IDMP is to improve patient safety through standardized identification and exchange of information on medicines and ingredients.
Chemical Watch Chemicals Management for Electronics USA 2020: Updates on Chem...raj takhar
Presented at the Chemical Watch Electronics USA 2020 conference.
This conference presentation covered emerging EU Chemical Sustainability Standards, based on flow down strategies from the EU Green Deal, with specific reference to the consultations being conducted following the publication of the EU Chemical Sustainability strategy released in October 2020.
Details of the conference can be found here: https://events.chemicalwatch.com/88945/chemicals-management-for-electronics-usa-2020
IERC 2015 Sustaining the US Electronics Recycling Market SalzburgEric Harris
The document discusses challenges facing the US electronics recycling industry, including producer responsibility laws, export regulations, and definitions of waste versus non-waste goods. It notes that over 80% of electronics are recycled domestically rather than exported. Third-party certification standards are growing to ensure environmentally sound recycling globally. Partnerships between recyclers help address large volumes of residential waste and challenges in commodities like CRT glass. A competitive circular economy requires global cooperation and competition between responsible recyclers.
Data Integrity; Ensuring GMP Six Systems Compliance Pharma TrainingMarcep Inc.
This document outlines a two-day workshop on data integrity compliance to meet regulatory standards. The workshop will cover data integrity requirements from the FDA, EU, and other regulators; challenges in ensuring data integrity across paper, hybrid, and electronic systems; best practices for data generation, recording, transformation and reporting; and conducting risk assessments and monitoring metrics to ensure ongoing data integrity. Attendees will learn how to strengthen internal audits and compliance across their quality systems, facilities, materials management, and other areas to meet data integrity expectations.
Counting for Large Property Portfolios | Sean Lockie icarb
The document summarizes presentations given at the Westminster Carbon counting conference in 2008. It discusses the need for standards in carbon accounting, presents three case studies of carbon accounting projects, and describes Atkins' development of a carbon manual to standardize their carbon services.
Maintaining A Materials Declaration Systemraj takhar
This document outlines topics for developing a material declaration management process, including: defining internal data flows; cleaning supplier and internal data; methods for exchanging declaration data; determining whether to outsource declaration processing; risk mitigation strategies; and collecting positive declarations from suppliers. It provides guidance on mapping article and supplier data, transmitting declaration requests, tracking responses, analyzing collected data, and engaging with suppliers.
This document summarizes a webinar on validating material information and collecting material analysis data. It discusses how material assay testing can provide valuable information about a product's material composition when combined with an electronic data management system. Material assay testing involves breaking products down into homogeneous materials and testing them to identify substances present. Challenges like ensuring data validity, completeness, and traceability over time can be addressed by linking material assay test reports to an electronic database system. This allows dynamic data updates and sharing of information with customers and suppliers in a standardized format.
Electronic chemicals and materials are used in the manufacturing of various electronic devices such as semiconductors, integrated circuits, and flat panel displays. These chemicals require advanced purification technologies to provide consistently low contaminant levels for processes like semiconductor manufacturing. Some examples of electronic chemicals include acids, electroplating solutions, etchants, fluorides, gases, pure elements, and semiconductor grade chemicals. The market for electronic chemicals and materials is projected to grow at a 7.7% compound annual rate from 2019 to 2024.
This document discusses the challenges of efficient data management for sustainable product design. It notes that legal frameworks like RoHS, REACH, and WEEE place huge demands on companies' data management systems. Existing systems for managing this data have limitations, including lack of integration between systems, uncertainty over data security, and dependence on externally controlled systems. The paper then presents a new solution called the iPoint Compliance Agent that aims to address these issues by enabling the automated exchange and integration of data across a company's internal systems and external sources to facilitate compliance checks throughout the supply chain.
The document discusses new mortgage disclosure requirements under TILA-RESPA that will take effect on August 1st. The new requirements consolidate four previous disclosures into two new forms: the Loan Estimate and Closing Disclosure. While the new disclosures are intended to be easier for consumers to understand, they present difficulties for lenders who must now use two separate systems to comply with the new rules or the previous rules depending on the type of mortgage. The new requirements will also require lenders and settlement companies to cooperate earlier in the process when providing the Closing Disclosure.
The document discusses photo backgrounds and props chosen for a college magazine to appeal to its target audience of college students. Lockers, a brick wall, stairs, papers, folders, IDs, and friends are included to represent common college experiences. One photo is rejected due to bright sun causing closed eyes. Revisions include using props to show old and new revision methods using paper and phone.
Bilcare_GCS Quality and Regulatory OveriewBilcare GCS
Bilcare is committed to providing innovative clinical trial material supply services globally according to quality and regulatory standards. It offers services including clinical trial manufacturing, packaging, labeling, sourcing of drugs, and storage and distribution. Bilcare aims to provide cost-effective and creative solutions through strategic partnerships to help customers succeed. It focuses on customer satisfaction, continual self-improvement, and compliance with regulations like cGMP, GCP, and ISO 9001. Bilcare works to improve through learning from audits and implementing systems improvements.
Jonathan Bennett has over 15 years of experience as a project manager in various industries. He is currently a senior project manager at Ellucian, where he manages the implementation of student management systems across multiple clients. Previously, he has held project management roles at The Collinson Group and The Chartered Insurance Institute. He has a BSc in Engineering with Business Studies and is a certified Project Management Professional with Prince2 qualifications.
An advertising campaign involves a series of coordinated messages over time that are centered around a consistent theme. This theme guides individual ads and marketing communications and determines the campaign's tone. Advertising campaigns can target local markets, entire regions, or be national in scope. Developing an effective campaign requires identifying the problem, setting a budget, pre-testing concepts, understanding the target audience, selecting appropriate media outlets, crafting compelling language and visuals, establishing the timing and duration, post-testing performance, and evaluating the impact on sales.
Bilcare GCS provides comparator drug procurement services for global clinical trials. It has expertise sourcing drugs worldwide and providing the necessary documentation and logistics to meet regulatory requirements. Bilcare can source drugs in large volumes and multiple batches with long expiration dates. It aims to provide authentic products, full traceability, and guidance to sponsors to enable cost savings. Bilcare has extensive experience procuring various drug types across multiple countries and regions.
BGCS is a specialist logistics provider for the life sciences sector globally, providing logistics solutions and transport of materials like clinical trial supplies, diagnostic materials, medical devices, and stem cells. It has a strong network of depot offices globally and in Europe to provide door-to-door shipments that are closely monitored. BGCS has experience handling dangerous goods across a range of temperatures. It aims to provide guaranteed time definite deliveries through dedicated customer service and real-time shipment information and monitoring.
The document analyzes the financial industry using Porter's five forces model. It finds that the threat of new entrants is low due to the lengthy regulatory approval process required. Rivalry is strong as institutions compete for customers and deposits. The threat of substitutes is high as customers frequently use multiple institutions. Suppliers like the Federal Reserve and credit card companies have significant bargaining power. The bargaining power of buyers is low for commercial banks but higher for credit unions which are member-owned.
This radio program document provides summaries of upcoming art, music, and cultural events in Australia. It discusses the Dark Mofo winter solstice festival in Hobart and an interview with a local artist involved. It also previews a tug-of-war art installation exploring social change in Prague. Additionally, it mentions that musician Antony donated funds from a music festival to an indigenous Australian group threatened by mining, and that a Senate inquiry was called to investigate cuts to federal arts funding.
Some frecuently used US slang and idioms. There are so many it was tough selecting which ones to add. However, I didn't want the ppt. to be overly long either. Enjoy :)
Bilcare GCS provides end-to-end clinical trial material supply chain services including packaging, labeling, storage, distribution, and returns/destruction. It has facilities in India and a global depot network to support clinical trials worldwide. Services include primary and secondary packaging, comparator sourcing, IVRS/IWRS, logistics and supply chain management, and QA/QC through qualified professionals and compliant facilities.
Bilcare GCS Packaging and Labeling CapabilitiesBilcare GCS
Bilcare GCS offers formulation development, clinical manufacturing, packaging, and labeling services to pharmaceutical and consumer healthcare clients. They have experienced scientists and state-of-the-art facilities to efficiently develop innovative formulations. Bilcare aims to help clients overcome challenges and accelerate time to market. Their integrated services allow seamless product development from formulation through clinical trials and commercialization. Bilcare has extensive experience producing various dosage forms and packaging configurations for clinical trials.
Infosys - RoHS Compliance Management | WEEE Directive White PaperInfosys
Companies must have a sustainability and compliance management strategy to comply with Restriction of Use of Certain Hazardous Substances (RoHS) and Waste Electrical and Electronic Equipment (WEEE) directives
This document provides an overview of worldwide product-based environmental regulations, with a focus on the ROHS and WEEE Directives in Europe. It discusses the background and motivations for these regulations, including the growing problem of electronic waste. The key points are:
- The ROHS Directive restricts the use of hazardous substances like lead, cadmium and mercury in electrical/electronic equipment in the EU. Compliance is required by July 2006.
- The WEEE Directive requires producers to manage post-consumer recycling and disposal of electronic products in the EU, effective August 2005.
- Similar regulations and restrictions exist or are being developed in the US, China, Korea and other countries/regions.
This document provides guidance for companies transitioning their manufacturing processes to comply with the upcoming RoHS directive which bans the use of lead and other hazardous substances. It discusses key issues companies need to consider such as planning the transition, changes to assembly processes like reflow soldering and wave soldering, reliability testing of lead-free solders, and ensuring components and materials meet the new compliance standards. The directive applies to all those involved in electronic equipment manufacturing and will require changes throughout the entire supply chain. Careful planning is needed to address issues around new processes, component changes, stock management and potential obsolescence as the industry moves to lead-free production by July 2006.
The document outlines the structure and agenda of TechUK's Environment and Compliance Programme. The programme focuses on reducing regulatory non-compliance risks for members, lowering costs through policy lobbying, and developing markets by promoting technology's role in sustainability. Key agenda items for 2016 include providing input on energy policy and carbon reporting obligations, assessing how technology can help meet carbon reduction targets, and advocating for chemicals regulation simplification to reduce business burdens. The programme also addresses product safety standards, export controls, and customs compliance.
The document discusses the Common Technical Document (CTD) format and electronic CTD (eCTD) format for registration dossier submissions. It provides background on the International Conference on Harmonization (ICH) and its role in harmonizing technical requirements for drug registration. The key points covered are:
1) The CTD format was created by ICH to provide a standardized common format for drug registration submissions across regions/countries.
2) The eCTD specification was later developed as the electronic equivalent of CTD to streamline the submission and review process.
3) Benefits of eCTD include improved handling of submissions, better information management, and increased efficiency of the evaluation and review process.
Flavio Cucchietti - Energy Efficiency and ICT: short term needs long term opp...iMinds conference
Telecom Italia is one of the largest energy consumers in Italy due to its extensive telecommunications network. The company consumed over 2,000 GWh of electricity in 2008, equivalent to the annual output of a nuclear power plant. While energy efficiency efforts over the past decade led to a 20% reduction in consumption, rising energy costs increased operating expenses. Further actions are needed to reduce the energy burden on both networks and customers. Standardization will be key to promoting energy-efficient technologies and achieving coordination across different sectors and regions.
CIGRE WG “Network of the Future” Electricity Supply Systems of the futurePower System Operation
The document discusses the key technical issues that will shape future electric power systems, as identified by a CIGRE working group. The 10 issues are: 1) active distribution networks with bidirectional power flows; 2) increased information exchange needs from advanced metering; 3) growth of HVDC and power electronics; 4) development and use of energy storage; 5) new concepts for system operation and control; 6) new protection concepts; 7) planning with environmental and technology changes; 8) tools for assessing technical performance; 9) increasing transmission infrastructure capacity; and 10) stakeholder engagement. The working group assesses which CIGRE study committees would be involved in addressing each issue.
CTD AND ECTD IN QUALITY ASSURANCE BY INTHIYAZ RIPERInthiyazBegum
The document discusses the Common Technical Document (CTD) format and the Electronic Common Technical Document (ECTD) format for submitting documentation to regulatory agencies for drug approval.
The CTD format was agreed upon in 2000 and standardized the organization of documentation into five modules: quality, non-clinical studies, clinical studies, and regional administrative information. The ECTD format further standardized electronic submission in an internationally agreed upon format to facilitate review. Benefits of the CTD and ECTD formats include global harmonization, easier preparation and review of submissions, and reduced costs. Risks of electronic submissions include technical issues and ensuring documentation is properly formatted and validated.
This document summarizes ITM Power's involvement in regulatory compliance and standards. It discusses ITM Power achieving ISO accreditation and CE marking for its electrolyzer systems. It also describes ITM Power's participation in the Hydrogen On Site Trials program to demonstrate hydrogen refueling and test fuel cell vehicles at 21 locations in the UK. The document provides details on standards for hydrogen purity, electrolyzer certification, and ITM Power's engagement with working groups developing hydrogen standards.
The large majority of all goods traded in the world today are electronic and electrical or depend on electrotechnology. Products are no longer “made in a country”; they are “made in the world”.
Before they are consumed in one market these products have traveled through many others. Countries are more interdependent than ever. Any country or company that wants to participate in these global value chains needs to work along universally accepted harmonized rules - in electrotechnology these are IEC International Standards. They are built on a global platform that brings together 165 countries and many thousand experts that represent national stakeholder needs at the global level in the IEC.
The document provides information for filing an Investigational New Drug (IND) application in electronic Common Technical Document (eCTD) format with the US FDA. It discusses the objectives of filing an IND for the drug Riociguat to treat pulmonary hypertension. It provides background on CTD and eCTD submission formats. It also includes details on the chemistry, manufacturing, and controls of Riociguat, preclinical and clinical studies, labeling, and stability data required for the IND application in eCTD format.
The document discusses the Research Data Alliance (RDA) and its process for having its technical specifications identified and approved as ICT Technical Specifications by the European Commission. The RDA works with various stakeholders to develop technical specifications that enhance data sharing and interoperability. Its specifications undergo an open review process before being submitted for identification. Previously identified RDA specifications include recommendations for data citation, repository requirements, and workflows for data publishing. The identification process involves review by the European Multi Stakeholder Platform and the European Commission to ensure specifications meet requirements for adoption in European public procurement.
RoHS, REACH, and Other Environmental Requirements Enviropass
This presentation delves into critical environmental regulations and requirements, focusing on the European Union's RoHS and REACH directives. It outlines the fundamental aspects of the RoHS directive, including its scope, basic rules, exemptions, technical documentation, and the CE mark.
RoHS
The gist of the European Union (EU) RoHS Directive:
https://www.getenviropass.com/europe-rohs/
- The scope
- Basic rules
- Exemptions list
- Technical documentation
- CE mark
Countries with RoHS regulations outside of the EU
EU REACH
What is it? How does REACH apply to articles?
https://www.youtube.com/watch?v=KnnoY4Byt8s&t=2s
• Article 33
• Substances of Very High Concern - SVHC
• The once an article, always an article principle
• The SCIP database and notification process (https://echa.europa.eu/scip)
• Annex XVII
Other Product Environmental Requirements
They include:
• Substance restrictions in products.
• Obligations to declare substance above certain thresholds.
• Declarations of products places into a specific market and Waste of Electrical and Electronic Equiment (WEEE)
• Energy efficiency.
• Conflict Mineralsè.
• Standards like ISO 14001 and IEC QC 080000
How to Comply with Substances Control
This section compares:
• analytical testing, such as the X-Ray Fluorescence (XRF) method for the detection of heavy metals; and
• documentary review, following standard IEC 63000
The presentation has been meticulously prepared by Aury Hathout from Enviropass, a leading expert in environmental compliance. For more information, visit: https://www.getenviropass.com/contact/
The Restriction of Hazardous Substances (RoHS) Manual for SMEszubeditufail
This document provides guidance on compliance with the RoHS Directive, which restricts the use of certain hazardous substances in electrical and electronic equipment. It defines key terms used in the RoHS Directive and requirements. It also discusses how producers can control parts to ensure compliance and how suppliers can establish their own parts control processes. Case studies from Korea, Japan, and China are presented to demonstrate how companies implement RoHS compliance in practice. The document aims to help small and medium enterprises understand and comply with RoHS requirements to maintain access to markets in the European Union.
ENTSO-E Draft Network Code for Operational Securitydavidtrebolle
- The draft Network Code on Operational Security lacks harmonization and leaves too much autonomy to individual TSOs, which could undermine security of supply across Europe and is inconsistent with the target model of an integrated EU electricity market.
- The code lacks clear and precise parameters and guidelines for TSO actions, using vague terms like "sufficient" instead of defined limits. This could result in unjustified actions by TSOs and loss of generation capacity.
- The code does not sufficiently consider the impact on electricity markets or refer clearly to other related framework guidelines and network codes on issues like balancing and capacity allocation. There is a need for greater coherence and consistency across codes.
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1. Challenges and Methods for Standardised Legal Compliance
Management in the Production of Electronics
Marek Stachura*1
, Nick Stein1
1
KERP Center of Excellence Electronics & Environment, Vienna, Austira
* Corresponding Author, marek.stachura@kerp.at, +43 1 272 0370 14
Abstract
Legal frameworks that govern usage of substances in electronics manufacturing have been growing in complexi-
ty. There is strong interest within the industry for standardization of reporting structures and the streamlining of
data exchange procedures. While internationally recognized compliance regulations, standards and company-
specific indicators are emerging, their complexity calls for sophisticated data management and legal background
knowledge. Companies are struggling to fulfil the multitude of requirements.
This paper gives a short overview about the relevant regulations, and summarizes the new standards that have
been developed by the International Electrotechnical Commission (IEC). Challenges are identified and interpret-
ed from the view of a practitioner; and a software-supported approach to information management is introduced.
This approach allows for automated process management, data exchange and automatic report generation, ena-
bling time-saving across whole business processes.
1 Current Situation
Production companies usually operate in a global
market, therefore they need to meet different require-
ments throughout the different regions of the world,
countries or districts (e.g. REACH and RoHS in Eu-
rope, China/Japan RoHS and REACH adaptations in
Asia, the Toxic Substances Control Act in the USA
etc.). This demands a huge effort through the introduc-
tion of the essential and usually very specific
knowledge on one hand (interpretation and fulfilment
of the legal requirements), and on the other hand mas-
sive data flows (such as material data exchange for
product structures with a highly expanded supply
chain). In addition, companies are under market pres-
sure to streamline their operations and improve cost-
efficiencies in order to remain competitive (shortening
time-to-market and lower prices margins). The bal-
ance between the very complex (and increasing) legal
requirements and the market pressure increases the
risk that compliance with the law, for some products
will not be secure enough. The risk of regulatory non-
compliance increases over time, as the regulations are
not static, but continuously developed and adapted
(e.g. regularly extension of the SVHC-list of
REACH). For these reasons, manual processing com-
pliance data is not feasible.
Only now are standards regarding material declaration
data exchange in the supply chain emerging. This is
the same for software tools that consider the issue of
legal compliance for products. Both are focused on
attempting to solve the problem of data exchange with
varying degrees success.
2 Short overview of the legal re-
quirements
Global regulations around the usage of materials and
substances are still quite varied and in the most not
harmonized. This unfortunate situation is likely going
to be prevalent for a long time. Nevertheless, certain
trends in the global markets can be observed. The Eu-
ropean Union plays a precursory role in worldwide
environmental regulations. Many countries and world
regions are adapting their legal framework to the Eu-
ropean regulations. This process has happened with
the regulations that currently dominate the industry.
Following are the main legal acts, listed with brief ex-
planations:
REGULATION (EC) No. 1907/2006 (EU-
REACH): Regulation on Registration, Evalua-
tion, Authorisation and Restriction of Chemi-
cals. Imposes on industry the responsibility for
assessing and managing the health risks of
chemicals and providing appropriate safety in-
formation to users. In parallel, the European
Union can take additional measures on highly
dangerous substances, where there is a need for
complementing action at EU level.
DIRECTIVE 2002/95/EC (EU-RoHS): Re-
stricts the usage of heavy metals such as lead,
mercury, cadmium, and hexavalent chromium,
2. as well as flame retardants such as polybromin-
ated biphenyls (PBB) or polybrominated diphe-
nyl ethers (PBDE) and requires substitution to
safer alternatives in electrical and electronic
equipment.
DIRECTIVE 2011/65/EU (EU-RoHS recast):
Revision of the RoHS Directive. The substances
covered remain the same, however the rules of
the first version of RoHS are extended to a much
wider range of products (e.g. to all electronic
equipment, cables and spare parts) and connects
the fulfilment of the RoHS requirements with
those of the CE-marking.
China New Chemical Substance Notification -
MEP Order No. 7 (China REACH): Similar to
EU REACH; adopts several principles and con-
cepts of the European regulation. The most no-
table differences existing between EU- and Chi-
na-REACH are in the registration scope and
testing requirements.
Administration on the Control of the Pollution
caused by Electronic Information Products
(China RoHS): Requirements apply to the same
substances like EU-RoHS, however the scope,
further responsibilities, exemption regulations
and product labelling are different. Implementa-
tion will be carried out in two phases.
US Toxic Substances Control Act (TSCA):
Regulates the introduction of new or already ex-
isting chemicals. In addition to regulation of
new substances, it also includes existing chemi-
cals (in contrast to the EU-REACH regulation).
The list of adequate laws worldwide is much longer
(adequate and further regulations are defined in other
countries and regions), but the examples mentioned
clearly illustrate the scale of the challenge. Only now
are industry and international approaches trying to
standardize responses to these requirements.
3 First standardization approach-
es for material declarations
Standardized reporting structures and streamlining of
data exchange procedures can significantly increase
the efficiency of securing a product’s legal conformity.
It is no surprise that the first standardization ap-
proaches were carried out by the industry participants
and industry associations, while the international
standardization organisations have gotten involved
much later on.
3.1 IPC-175x family of standards
The Association Connecting Electronics Industries has
issued a series of standards known as IPC175x family:
IPC-1751- Generic Requirements for Declara-
tion Process Management: Provides the princi-
ples and details for declarations necessary be-
tween members of a supply chain relationship
[3].
IPC-1752- Materials Declaration Management:
Establishes a standard reporting format for ma-
terial declaration data exchange between supply
chain participants and supports reporting of bulk
materials, components, printed circuit boards
(PCBs), sub-assemblies and products [4].
IPC-1756- Manufacturing Process Data Man-
agement: Establishes defined fields for declara-
tion of manufacturing data as a support for elec-
tronic tools [5].
IPC-1758- Declaration Requirements for Ship-
ping, Packing and Packaging Materials: De-
scribes essential information exchange content
with respect to packing, supplemented by regu-
lation references for materials, marking, recy-
cling information and recycled content [6].
Further relevant standards are currently in develop-
ment:
IPC-1753: Laminate Structure Declaration
Management
IPC-1754: Printed Board Declaration Manage-
ment
IPC-1755: Electronic Assembly Declaration
Management
The main approach of this standards family is to in-
troduce the process of data managing, the form of data
exchange and the content of exchanged data and tried
to consider the most important requirements of the
wold legal requirements (see chapter 2).
Even though the IPC standards have reached relative
widely recognized status and introduced a pointer out
of the electronic industry but they don’t have the sta-
tus of international standard.
3.2 IEC-62474
The first international standard for material declara-
tion in the electrotechnical industry is called IEC
62474 Edition 1.0 (2012-03), published by the Inter-
national Electrotechnical Commission.
This standard is aimed at harmonizing requirements
for the exchange of material composition data across
the supply chain. To this end, it provides reporting
substances and materials and defines protocols.
There is a database which contains the substances,
substance groups, material classes and typical applica-
3. tions examples, reporting thresholds and basic criteria
for inclusion. There are three basic inclusion criteria
are:
“Currently regulated”: Substance group or sub-
stance with a “mandatory reporting require-
ment”, included within an existing national law
or regulation in an IEC Member country [1]
(prohibited, restricted or, to declare the usage in
electrotechnical products by a specific date)
“For information only”: Substance group or
substance with a “mandatory reporting require-
ment”, included within an existing national law
or regulation in an IEC Member country [1]
(prohibited, restricted or, to declare the usage in
electrotechnical products without a specific
date)
“For assessment”: Substance group or substance
with a “optional reporting requirement”, cur-
rently not regulated in an existing national law
or regulations in an IEC Member country [1]
but there is a recognized industry-wide common
market requirement for reporting this substance
group or substance in electrotechnical products.
Figure 1 displays the base mandatory requirements for
a material declaration according to IEC 62474. They
include the reporting of any substances and substance
groups (listed in the database) included in the final
product that is provided to customers. Furthermore,
every homogeneous material that contains a declarable
substance above the given threshold needs also to be
declared [2].
Figure 1: IEC42474 base requirements for materi-
al declaration [2]
The additional declaration requirements are summa-
rised in figure 2. Reporting of additional substances
(not contained in the database of declarable substanc-
es), substance groups, product (sub)parts and material
classes is optional.
IEC 62474 defines a XML format, developers’ table
and schema for electronic data exchange. Its purpose
is to help in-house and commercial software develop-
ers have a standardized method of data exchange [2].
Figure 2: IEC42474 additional requirements for
material declaration [2]
4 Concept of a data management
and compliance system
In the electronics industry, there are a number of par-
allel systems for the communication, exchanging of
material data and compliance checks in the supply
chain. This is to be expected due to the very high
number of suppliers in this field. So far, a widely ac-
cepted joint system could not be achieved; hence it is
not realistic to expect an industry-wide homogeneous
solution. Most production companies prefer to devel-
op their own systems or to join different systems (see
chapter 2). Therefore, a flexible solution for the ex-
change of information between systems is needed.
The exchange of information shall take place between:
Commercial software solutions (such as
IMDS and BOMcheck)
Existing in-house IT environments
Companies own systems for material declara-
tion
Various public data systems, such as the Eu-
ropean Chemicals Agency (ECHA) or the
German hazardous materials information sys-
tem (GESTIS).
The software integration tool iPoint Compliance
Agent (iPCA) implements this approach. The system
accesses the existing component, material and sub-
stance data throughout the value chain. Additionally,
for the communication outside of existing systems,
iPCA offers a module for data delivery/import, e.g. the
Supplier Entry Portal (see Figure 3). Figure 3 shows
the core modules of iPCA with an expanded material
and supplier management functionality, including the
ability to connect and communicate with the in-house
4. PDM/PLM system. Connection with a supplier’s in-
ternal systems is possible via a “Supplier Entry Por-
tal” (data communication with supplier). Here, special
interfaces allow for data to be uploaded from the sup-
plier’s own system or through manual data input. Fur-
ther interfaces connect the system with other third par-
ty systems (e.g. the European Chemicals Agency
ECHA, or the German hazardous materials infor-
mation system GESTIS). Additionally, a specialized
functionality, known as agent technology, searches the
available data online which is provided by suppliers.
Figure 3: Integration of systems in iPCA
With iPCA, an open communication between different
systems is implemented. Concurrently, a user admin-
istration with clearly defined rights has been devel-
oped. This ensures high data security, while providing
filtered and task-oriented access to the required data.
In order to effectively secure the intellectual property
of the manufacturers, the iPCA application runs local-
ly on the in-house system. Thus, all product-specific
data (bill of material, specifications, compliance doc-
uments, etc.) are saved and managed exclusively on
the in-house PDM systems.
Figure 4 shows the complete process of conformity
assessment by iPCA. The compliance check of a
product is started by the user (legal or quality manag-
ers) importing the bill of material (BOM) from the in-
house PDM system. The input data will be automati-
cally imported and verified by iPCA. The data check
covers both the correctness of the individual items in
the bill of material (that means questions like com-
pleteness of parts, naming of used units, correctness of
part numbers etc.) and, for all components, a part
number search in the system database. If the compo-
nent is already saved in the system and contains suffi-
cient supplier information, it will be identified and
used for the current and future bill of material anal-
yses and compliance checks. For new, unknown com-
ponents or components with insufficient information,
the appropriate suppliers will be asked to deliver the
relevant information via the Supplier Entry Portal
(SEP). In this way, the system constantly monitors in-
formation already existing in the system or available
on publicly held sources. The input information (mate-
rial declaration, conformity certificate, negative decla-
ration, etc.) will be checked for plausibility and com-
pleteness by the user and for positive results saved in
the system (that means questions like naming of sub-
stances, used units, form and contents of specification
related to a given regulation etc.).
Figure 4: Process flow for checking compliance
with iPCA
In case the data delivered is unusable, another query
will be sent to the supplier. The process of information
collection is automated and the user interaction is re-
duced to a necessary minimum (control of data input).
In the next step, the complete bill of materials is
checked for compliance with pre-defined legal re-
quirements (e.g. RoHS, REACH, ELV etc.). This
means that the legal requirements (e.g. restrictions of
use of specific substances according to REACH) will
be identified, calculated, and compared to the current
limits defined by the regulation. If a substance includ-
ed in a sub-part exceeds the tolerable concentration, a
warning and an adequate report will be created auto-
matically by the system. A team of experts and system
managers makes sure that the legislative changes are
promptly reflected by the application. Each completed
compliance check must be approved by a user before
the information can be saved in the in-house PDM
system. Based upon a check of the bill of materials
and the generated information, the relevant reports
will be automatically created by the system (e.g.
MSDS, reports for public regulators, declaration let-
5. ters etc.). The iPoint Compliance Agent organizes and
manages the entire process of information collection,
integration into in-house systems, analysis and report-
ing.
The most important feature of iPCA is the communi-
cation with other external system and the data integra-
tion into the company-internal PDM/PLM system.
This allows for high data viability on one side and
guarantees the protection and custody of critical intel-
lectual property on the other side.
As well as the compliance check and generating of
COC’s (Certificates of Conformity), the information
collected in the system gives a good basis for improve
sustainability strategies in the development of a prod-
uct. For example, the material specification delivers
appropriate basic information for a Life Cycle As-
sessment of products, and can be later used for the op-
timization of the environmental performance of prod-
ucts and production processes.
5 Conclusion
An effective material declaration system should not
only operate with a company’s own supply chain and
be well integrated into internal data management
structures, but should also have the ability to com-
municate with other external systems in a global envi-
ronment. This kind of communication is only possible
when adequate data exchange standards are defined,
promoted, implemented and adhered to.
6 Literature
[1] List of IEC members, 2012 [Online] Available:
www.iec.ch
[2] IEC 62474 Ed. 1.0, “Material declaration for
products of and for the electrotechnical indus-
try”, Standard developed by International Elec-
trotechnical Commission, 2012-03.
[3] IPC-1751 Version 2.0, “Generic Requirements
for Declaration Process Management”, Standard
developed by Association Connecting Electron-
ics Industries, 2010.
[4] IPC-1752 Version 2.0, “Materials Declaration
Management”; Standard developed by Associa-
tion Connecting Electronics Industries, 2010
[5] IPC-1756 Version 2.0, “Manufacturing Process
Data Management”, Standard developed by As-
sociation Connecting Electronics Industries,
2010.
[6] IPC-1758, “Declaration Requirements for Ship-
ping, Pack and Packing Materials”, Standard de-
veloped by Association Connecting Electronics
Industries, Pre-publication 2012.