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Chapter 11. Fire Alarms and Democratic Accountability Charles M. Cameron and Sanford C. Gordon
Chapter 11. Fire Alarms and Democratic Accountability Charles M. Cameron and Sanford C. Gordon 1 Introduction Accountability is a situation that prevails in any relationship between a principal and agent in which the latter takes some action for which she may be \held to account" { that is, made to answer for those actions under a system of rewards and sanctions administered by the former. In a democratic setting, the electorate are the principals and public officials the agents; rewards and sanctions the loss or retention of the benefits, privileges, and powers of office-holding. Absent electoral accountability, citizens must fall back on the benevolence of their rulers or just plain luck. History shows these are weak reeds indeed. Thus, the accountability (or unaccountability) of elected officials to voters is a key component of any comprehensive theory of democratic governance. Electoral accountability faces huge obstacles in practice. One of the most pernicious is the problem of asymmetric information: while knowing what politicians are up to is surely a critical ingredient of holding incumbent officeholders to account, for most voters, becoming and remaining informed about whether elected officials are actually meeting their obligations can be tedious, time- consuming and difficult. How many citizens have the leisure to research the voting record of their member of Congress, for instance? And even then, outside of a few specific areas, how many have the knowledge to assess whether a given legislative enactment actually improved their welfare, all things considered? A lack of transparency about actions and the obscurity between means and ends can render nominal accountability completely moot in practice.1 In the face of prohibitive information costs, a simple intuition is the following: any mechanism that lowers informational costs for voters ought to enhance electoral accountability. -
The Gxp Dictionary 1St Edition
Testo Expert Knowledge The GxP Dictionary 1st edition Definitions relating to GxP and Quality Assurance 1 Note: Some of the information contained in this GxP Dictionary does not apply equally to all countries. Depending on the respective local legislation, other definitions may apply to certain terms and topics. The sections affected are not separately identified. 2 Foreword Efficacy, identity and purity are qual- This GxP Dictionary explains the ity attributes, which are required of majority of terms relating to GxP, products from the GMP-regulated qualification, validation and quality environment. The term “Good Manu- assurance. facturing Practice” sums up the quality assurance requirements from national It is intended as a compact reference and international regulations and laws. guide and aid for all those involved Other GxP forms have now been de- in GMP, and does not purport to be veloped, whose scope also expands complete. to adjacent sectors such as medical devices and life sciences. Testo SE & Co. KGaA The complex requirements of the “GMP compliance” generate a variety of specific concepts and abbrevia- tions. 3 GxP Dictionary Contents Contents 10 Terms and Definitions C 15 Calibration 0-9 15 CAPA 10 21 CFR 210/211 15 Capacity Test 10 483 15 CEP (Certificate of Suitability of Monographs of the European A Pharmacopoeia) 11 Action Limits 15 CFR 11 Active Pharmaceutical Ingredient 15 CFU (Colony-Forming Unit) (API) 16 cGMP 11 ADI (Acceptable Daily Intake) 16 Challenge Test 11 Airlock Concept 16 Change Control 11 Annex 16 Clean Corridor -
Introduction to Medical Device Law and Regulation March 2-4, 2021 | Live Virtual Event Speaker Biographies
Introduction to Medical Device Law and Regulation March 2-4, 2021 | Live Virtual Event Speaker Biographies DEBORAH BAKER-JANIS joined NSF International in 2013 after working in the medical device industry for over 10 years, including in both regulatory affairs and product development. Her experience includes the development of pre‐clinical testing protocols, risk documentation, quality system and regulatory affairs standard operating procedures, sales training materials, safety reports and domestic and international regulatory strategies and submissions. Ms. Baker‐Janis has supported the development and commercialization of a wide range of products including cardiovascular devices, general and plastic surgery devices, gastroenterology devices and general hospital devices. Her educational background is in biomedical engineering. MAHNU DAVAR is a partner in the Washington, DC office of Arnold & Porter. His practice focuses on assisting FDA-regulated entities with complex regulatory and compliance matters. He has represented early stage medical technology companies, clinical labs, major academic research institutions, and some of the largest multinational drug and device companies in the oncology, ophthalmology, pain, and diabetes care spaces. Mr. Davar routinely counsels clients on the regulatory and compliance aspects of promotional launch campaigns, clinical research, educational grants and charitable giving, manufacturing and supply chain, deal diligence, and other mission-critical activities. He has conducted significant compliance investigations and audits for business operations in the US, Europe, and Asia, and has extensive experience defending companies in criminal and civil healthcare fraud investigations. He has also assisted clients to prepare for and navigate state and federal regulatory inspections. Mr. Davar is a lecturer at the University of Pennsylvania Law School, a Fellow of the Salzburg Global Seminar, and a former Fulbright Scholar to India. -
Intertek Pharmaceutical Services
PHARMACEUTICAL SERVICES Laboratory & Assurance Solutions INTERTEK PHARMACEUTICAL SERVICES Total Quality Assurance for Pharmaceutical Development and Manufacturing Across your product lifecycle, our expertise brings you the insight you need to accelerate pharmaceutical, biopharmaceutical or medical device product development. Our assurance solutions allow you to identify and mitigate risks associated with products, processes, operational and quality management systems, assets and supply chains. Our specialists bring many years of experience across a variety of product areas including: • Innovative and Generic Pharmaceuticals • Orally Inhaled and Nasal Drug Products • Peptides, Proteins • Nutritional Products, Dietary • Biosimilars Supplements • Monoclonal Antibodies • Consumer Healthcare and Cosmetics • Antibody-drug Conjugates • Medical Devices • Oligonucleotide Therapeutics • Veterinary Medicines • Vaccines • Over-the-Counter (OTC) Drugs 2 Achieving Total Quality You can rely on our global network of experts, Assurance laboratories and specialists to deliver support We have delivered flexible including analysis, bioanalysis, formulation Our scientists, regulatory experts and auditors development, biologics characterization, contract services to the work with you at every stage of development specialist inhalation development expertise, global pharmaceutical and manufacturing, providing responsive, regulatory consultancy, risk assessment, quality compliant solutions. auditing and supply chain management industry for over 25 years At Intertek, -
Why AWS for Gxp Regulated Workloads? an Executive Summary
Why AWS for GxP regulated workloads? An executive summary Move, or build, GxP workloads in the cloud with help from the AWS Life Sciences Practice The AWS life sciences practice and dedicated GxP experts help biopharma and medical device companies build new, or move, regulated workloads to the cloud. Organizations can achieve higher productivity, increased operational resilience, greater agility, improved transparency and traceability, and a lower TCO1 and carbon footprint on AWS2 compared to on-premises systems. AWS offers a secure cloud platform for automating compliance processes and providing enhanced management related to running your GxP workloads. Some of the biggest enterprises and innovative startups in life sciences have moved, or built new GxP systems on the AWS Cloud. Decades of expertise in the life sciences space enable us to help you move away from on-premises regulatory paradigms as your trusted advisor to becoming regulated cloud native. Evidence of success: Evidence of success: AWS customers AWS partners Moderna power their R&D and manufacturing Aizon use AWS to enable real-time visibility and environments on AWS to accelerate the development predictive insights that address GxP compliance. of mRNA therapeutics and vaccines. Idorsia house 90% of IT operations on AWS, including Core Informatics developed a platform on AWS that GxP compliant virtual data centers, giving them 75% enables GxP-validated applications in the cloud for cost savings compared to physical data centers its customers. Bristol Myers Squibb use AWS to create consistent, Tracelink choose AWS to support its life science scalable, and repeatable process to streamline cloud solution to meet customer compliance needs. -
Suggestions from Social Accountability International
Suggestions from Social Accountability International (SAI) on the work agenda of the UN Working Group on Human Rights and Transnational Corporations and Other Business Enterprises Social Accountability International (SAI) is a non-governmental, international, multi-stakeholder organization dedicated to improving workplaces and communities by developing and implementing socially responsible standards. SAI recognizes the value of the UN Working Group’s mandate to promote respect for human rights by business of all sizes, as the implementation of core labour standards in company supply chains is central to SAI’s own work. SAI notes that the UN Working Group emphasizes in its invitation for proposals from relevant actors and stakeholders, the importance it places not only on promoting the Guiding Principles but also and especially on their effective implementation….resulting in improved outcomes . SAI would support this as key and, therefore, has teamed up with the Netherlands-based ICCO (Interchurch Organization for Development) to produce a Handbook on How To Respect Human Rights in the International Supply Chain to assist leading companies in the practical implementation of the Ruggie recommendations. SAI will also be offering classes and training to support use of the Handbook. SAI will target the Handbook not just at companies based in Western economies but also at those in emerging countries such as Brazil and India that have a growing influence on the world’s economy and whose burgeoning base of small and medium companies are moving forward in both readiness, capacity and interest in managing their impact on human rights. SAI has long term relationships working with businesses in India and Brazil, where national companies have earned SA8000 certification and where training has been provided on implementing human rights at work to numerous businesses of all sizes. -
From Corporate Responsibility to Corporate Accountability
Hastings Business Law Journal Volume 16 Number 1 Winter 2020 Article 3 Winter 2020 From Corporate Responsibility to Corporate Accountability Min Yan Daoning Zhang Follow this and additional works at: https://repository.uchastings.edu/hastings_business_law_journal Part of the Business Organizations Law Commons Recommended Citation Min Yan and Daoning Zhang, From Corporate Responsibility to Corporate Accountability, 16 Hastings Bus. L.J. 43 (2020). Available at: https://repository.uchastings.edu/hastings_business_law_journal/vol16/iss1/3 This Article is brought to you for free and open access by the Law Journals at UC Hastings Scholarship Repository. It has been accepted for inclusion in Hastings Business Law Journal by an authorized editor of UC Hastings Scholarship Repository. For more information, please contact [email protected]. 2 - YAN _ZHANG - V9 - KC - 10.27.19.DOCX (DO NOT DELETE) 11/15/2019 11:11 AM From Corporate Responsibility to Corporate Accountability Min Yan* and Daoning Zhang** I. INTRODUCTION The concept of corporate responsibility or corporate social responsibility (“CSR”) keeps evolving since it appeared. The emphasis was first placed on business people’s social conscience rather than on the company itself, which was well reflected by Howard Bowen’s landmark book, Social Responsibilities of the Businessman.1 Then CSR was defined as responsibilities to society, which extends beyond economic and legal obligations by corporations.2 Since then, corporate responsibility is thought to begin where the law ends. 3 In other words, the concept of social responsibility largely excludes legal obedience from the concept of social responsibility. An analysis of 37 of the most used definitions of CSR also shows “voluntary” as one of the most common dimensions.4 Put differently, corporate responsibility reflects the belief that corporations have duties beyond generating profits for their shareholders. -
Institutions, Organizations and Individuals Advocating for Corporate Accountability Condemn Chevron's Retaliatory Attacks on H
Institutions, Organizations and Individuals Advocating for Corporate Accountability Condemn Chevron’s Retaliatory Attacks on Human Rights and Corporate Accountability Advocates and See it as a Serious Threat to Open Society and Due Process of Law January 23, 2014 - We, the undersigned organizations and individuals, condemn the actions by Chevron in its efforts to silence critics and ignore a $9.5 billion judgment against it for environmental damage in the Ecuadorian Amazon. Chevron’s actions set a dangerous precedent and represent a growing and serious threat to the ability of civil society to hold corporations accountable for their misdeeds around the world. Since Chevron launched its attack on those who have been working for decades to pressure the company to clean up the environmental damage caused by its operations in the Ecuadorian Amazon, independent journalists have been forced to turn over their material and nonprofit watchdog groups have faced massive legal actions designed to cripple their ability to work and undermine their ability to grow support for their efforts. Attacks Free Speech In a move opposed by The New York Times, ABC, CBS, NBC, Dow Jones, the Associated Press, the Hearst Newspapers, the Daily News, and the Gannett Company, Chevron used its legal might to launch a major threat to independent journalism when it won a decision to force documentary producer and director Joe Berlinger to turn over to Chevron more than 600 hours of raw footage. Chevron has also targeted nonprofit environmental and indigenous rights groups and individual activists with subpoenas designed to cripple their effectiveness and chill their speech. -
What Is Corporate Accountability?
WHAT IS CORPORATE ACCOUNTABILITY? BACKGROUND AND OVERVIEW Since the 1990s, the world has witnessed the growing importance and visibility of a range of initiatives led by businesses, social organisations and governments, with the stated aim of pressuring companies to behave in more socially responsible and accountable ways. This is a new development for many parts of the business world. Previously, the state (or government) was assumed to lead standard setting and behavioural norms for businesses in relation to most categories of stakeholders. When community organisations and interest groups wanted to change business behaviour, they focussed on changing the law. From the 1990s the focus changed, reflected in the emergence of new alliances and regimes of influence over business norms, linking together consumers, communities, workers and producers. What is the difference between corporate social responsibility (CSR) and corporate accountability? Corporate responsibility, corporate social responsibility (CSR) and corporate accountability are sometimes confused or seen to be synonymous. However, corporate responsibility and corporate accountability are typically distinguished from one another along several lines. Corporate responsibility in its broadest sense refers to varied practices that reflect the belief that corporations have responsibilities beyond generating profit for their shareholders. Such responsibilities include the negative duty to refrain from harm caused to the environment, individuals or communities, and sometimes also positive duties to protect society and the environment, for example protecting human rights of workers and communities affected by business activities. Such responsibilities are generally considered to extend not only to direct social and environmental impacts of business activity, but also to more indirect effects resulting from relationships with business partners, such as those involved in global production chains. -
The Challenge of Compliance in Life Sciences Moving from Cost to Value
The challenge of compliance in life sciences Moving from cost to value To start a new section, hold down the apple+shift keys and click to release this object and type the section title in the box below. Contents Foreword 1 Executive summary 3 Overview of compliance 4 Compliance insights 6 The future of compliance 18 Glossary 19 Contacts 20 The Deloitte Centre for Health Solutions The Deloitte Centre for Health Solutions, part of Deloitte UK, generates insights and thought leadership based on the key trends, challenges and opportunities within the healthcare and life sciences industry. Working closely with other centres in the Deloitte network, including the US centre in Washington, our team of researchers develop ideas, innovations and insights that encourage collaboration across the health value chain, connecting the public and private sectors, health providers and purchasers, and consumers and suppliers. In this publication, references to Deloitte are references to Deloitte LLP, the UK member firm of DTTL. To start a new section, hold down the apple+shift keys and click to release this object and type the section title in the box below. Foreword Welcome to the Deloitte UK Centre for Health Solutions’ report on The challenge of compliance in life sciences: Moving from cost to value. Seeing the challenges that life sciences clients face in responding to an increasingly complex regulatory environment led us to launch an independent research initiative which set out to identify: • how well the industry understands the totality of its compliance risks • how compliance is managed and implemented within life sciences companies • what the future of compliance looks like. -
Columbia Tech Completes Successful ISO Reassessment Audit
Columbia Tech Completes Successful ISO Reassessment Audit May 01, 2014 10:16 AM Eastern Daylight Time WORCESTER, MA -- Coghlin Companies announced today that Columbia Tech, a wholly-owned subsidiary specializing in manufacturing and global fulfillment services, has completed a successful ISO reassessment audit. Over a period of three days, a team of independent auditors from Intertek conducted an in-depth analysis and verified that Columbia Tech is adhering to all internal documented procedures and is fully compliant with ISO 9001:2008 and ISO 13485:2003. The auditors stated that Columbia Tech has an excellent Quality Management System and indicated how impressed they were with Columbia Tech’s management team, staff of caring associates, and their well-organized new manufacturing facility in Westborough, MA. Eric Skoglund, Columbia Tech’s Quality Control Manager and Management Representative, said, “It has long been recognized that ISO standards lead to improved quality and, as a direct result, enhance overall customer satisfaction time after time. Our current and future customers will continue to experience the benefits of collaborating with a partner that is completely dedicated to providing the highest quality products and services and an exceptional customer experience.” ISO 9001 is an international quality standard developed by the International Organization for Standardization (ISO) based on Quality Management Principles, including mutually beneficial supplier relationships, continuous improvement, and a customer-centric focus. These principles are incorporated within the requirements of the standard to improve organizational performance. ISO 13485 meets domestic and international regulations for medical device manufacturing, while achieving overall business improvement. About Columbia Tech Columbia Tech provides Time to Market Services at WARP SPEED™, including engineering design, manufacturing, global fulfillment and aftermarket services. -
Data Integrity for Computerized Systems in Gxp Regulated Applications
White Paper www.vaisala.com Managing GxP environmental systems to ensure data integrity In this paper, we provide an overview of data management best practices for life science systems and an overview of regulatory expectations. We offer eight recommendations for establishing and maintaining good practices for data integrity. More than Bytes management, companies can find Thanks to the publication of and Signatures changes hard to implement in terms enforcement actions such as GMP of updating systems and behavior. non-compliance reports, warning As efforts to ensure the quality and letters, import alerts, and notices, safety of drugs increase, so does it is evident that regulators are the amount of data generated by Data integrity: targeting data integrity failures those efforts. Over the last few Related regulations during inspections. Subsequent years, global regulatory scrutiny has turned to providing guidance Data integrity requirements are enforcement actions have led to on preserving the integrity of data. core elements of basic GMPs, and the withdrawal of supply across Throughout life science industries are broadly addressed in the FDA’s multiple markets, product recalls, — pharmaceutical, medical devices, Title 21 CFR Part 11 and the EU's consent decrees, and reputational and biotechnology research and GMP Eudralex Volume 4, Chapter damage for the firms involved. production — regulatory guidance 4 and Annex 11. However, with With increased targeting of and enforcement strategies are data integrity from regulators, being re-evaluated with a focus increasing automation based on it is now crucial that everyone on data integrity. With increasing computerized systems, as well as involved in GxP-regulated awareness of data collection and the globalization of operations storage, there comes increased and the increasing cost of bringing activities understand correct data awareness of gaps between products to market, new guidance management practices.