The Regulatory Compliance Almanac

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Publisher : Paton Professional
ISBN 13 : 9781932828191
Total Pages : 564 pages
Book Rating : 4.8/5 (281 download)

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Book Synopsis The Regulatory Compliance Almanac by : Les Schnoll

Download or read book The Regulatory Compliance Almanac written by Les Schnoll and published by Paton Professional. This book was released on 2008 with total page 564 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Medical Device Quality Assurance and Regulatory Compliance

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Publisher : CRC Press
ISBN 13 : 9780824701772
Total Pages : 504 pages
Book Rating : 4.7/5 (17 download)

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Book Synopsis Medical Device Quality Assurance and Regulatory Compliance by : Richard C. Fries

Download or read book Medical Device Quality Assurance and Regulatory Compliance written by Richard C. Fries and published by CRC Press. This book was released on 1998-08-11 with total page 504 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Acquaints developers of medical devices with the basic concepts and major issues of medical quality assurance and regulatory documents, describes the requirements listed in these documents, and provides strategies for compliance with these requirements."

Certification and Accreditation Programs Directory

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Publisher :
ISBN 13 :
Total Pages : 644 pages
Book Rating : 4.4/5 (91 download)

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Book Synopsis Certification and Accreditation Programs Directory by :

Download or read book Certification and Accreditation Programs Directory written by and published by . This book was released on 1996 with total page 644 pages. Available in PDF, EPUB and Kindle. Book excerpt:

The ASQ Certified Quality Auditor Handbook

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Publisher : Quality Press
ISBN 13 : 1951058100
Total Pages : 417 pages
Book Rating : 4.9/5 (51 download)

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Book Synopsis The ASQ Certified Quality Auditor Handbook by : Lance B. Coleman

Download or read book The ASQ Certified Quality Auditor Handbook written by Lance B. Coleman and published by Quality Press. This book was released on 2020-02-01 with total page 417 pages. Available in PDF, EPUB and Kindle. Book excerpt: The value of the ASQ Certified Quality Auditor Handbook, Fifth Edition, is clear. It is designed to help new auditors gain an understanding of the field and prepare for the ASQ CQA exam. In addition, experienced auditors can refer to it as a helpful reference; audit managers and quality managers can rely on it for guiding their auditing programs; and trainers and educators can use it for teaching fundamentals. This in-depth overview of quality auditing represents auditing practices for internal and external applications. It provides practical guidance for both system and process auditors as well. Many current topics have been expanded to reflect changes in auditing practices since 2012, with guidance from the recent 2017 update of ISO 19011. In addition, readers will find example audit situations, stories, and review comments to enhance their understanding of the field. Topics covered include the common elements of all types of system and process audits (quality, environmental, safety, and health): Auditing fundamentals, including types of quality audits, purpose and scope of auditing, terms and definitions, roles and responsibilities of participants, and professional conduct The audit process, from preparation and planning, to performance and reporting, to follow-up and closure Auditor competencies, including resource management, conflict resolution, communication, interviewing, and team dynamics Audit program management and business applications, including staffing, training and development, program evaluation, organizational risk management, and best practices Quality tools and techniques, including problem-solving tools, process improvement techniques, basic statistics, verification, and validation "This book is an encyclopedia of all major bodies of information a new or experienced quality auditor would need. It covers both the qualitative and the quantitative, which is a strength. I can't think of a quality auditor that would not find this work helpful." Kim H. Pries, CRE, CQE, CSQE, CSSBB, CMQ/OE, CQA "This handbook will be helpful to those who are new to auditing or require more in-depth knowledge of the implementation of an audit program. Boxed examples or scenarios provide some of the practical challenges encountered during auditing." Govind Ramu, ASQ Fellow, Co-Author ASQ SSGB Handbook, Author ASQ CSSYB Handbook Lance B. Coleman, Sr. has over 25 years of leadership experience in the areas of quality engineering, Lean implementation, quality, and risk management in the Medical Device, Aerospace, and other regulated industries. He has presented, trained, and consulted throughout the United States and abroad. Lance is currently a Director of Quality for IDEX Health and Science, LLC, in Oak Harbor, Washington.

Manual for the Certification of Laboratories Analyzing Drinking Water

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Author :
Publisher :
ISBN 13 :
Total Pages : 204 pages
Book Rating : 4.3/5 (121 download)

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Book Synopsis Manual for the Certification of Laboratories Analyzing Drinking Water by :

Download or read book Manual for the Certification of Laboratories Analyzing Drinking Water written by and published by . This book was released on 1997 with total page 204 pages. Available in PDF, EPUB and Kindle. Book excerpt:

The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

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Author :
Publisher : Springer
ISBN 13 : 3030137546
Total Pages : 446 pages
Book Rating : 4.0/5 (31 download)

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Book Synopsis The Challenge of CMC Regulatory Compliance for Biopharmaceuticals by : John Geigert

Download or read book The Challenge of CMC Regulatory Compliance for Biopharmaceuticals written by John Geigert and published by Springer. This book was released on 2019-05-08 with total page 446 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biopharmaceuticals (i.e., biological medicines sourced from genetically-engineered living systems) for treatment of human diseases have become a significant percentage of the pharmaceutical industry. And not just the recombinant DNA-derived proteins and monoclonal antibodies (both from the innovators and biosimilars); but now, an increasing awareness of the importance of gene therapy and genetically engineered cellular medicinal products. These biopharmaceuticals are being developed by many companies whose Chemistry, Manufacturing & Control (CMC) teams have varying degrees of familiarity or experience with the CMC strategy and regulatory compliance requirements for these challenging products. Companies clearly plan out the strategy for their clinical study plans, but frequently, the development of a strategy for CMC is an afterthought. Coupled with the complexity of the biopharmaceutical manufacturing processes and products, and this can be a recipe for disaster. The third edition of this book provides insights and practical guidance for the CMC teams to develop an acceptable cost-effective, risk-based CMC regulatory compliance strategy for all biopharmaceuticals (recombinant proteins, monoclonal antibodies, genetically engineered viruses and genetically engineered human cells) from early clinical stage development through market approval. The third edition of this book provides added coverage for the biosimilars, antibody drug conjugates (ADCs), bispecific antibodies, genetically engineered viruses, and genetically engineered cells. This third edition of the book also addresses the heightened pressure on CMC regulatory compliance timelines due to the introduction of expedited clinical pathways moving the clinical development closer to a seamless phase process (e.g., FDA Breakthrough Therapy designation, CBER Regenerative Medicine Advanced Therapy (RMAT) designation, EMA Priority Medicines (PRIME) designation). The Challenge of CMC Regulatory Compliance for Biopharmaceuticals is essential, practical information for all pharmaceutical development scientists, Manufacturing and Quality Unit staff, Regulatory Affairs personnel, and senior management involved in the manufacture of biopharmaceuticals.

A Review of Managing Quality and a Primer for the Certified Quality Manager Exam

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Author :
Publisher : ASQ Quality Press
ISBN 13 :
Total Pages : 360 pages
Book Rating : 4.3/5 ( download)

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Book Synopsis A Review of Managing Quality and a Primer for the Certified Quality Manager Exam by : THOMAS J. CARTIN

Download or read book A Review of Managing Quality and a Primer for the Certified Quality Manager Exam written by THOMAS J. CARTIN and published by ASQ Quality Press. This book was released on 1997 with total page 360 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Regulated Bioanalysis: Fundamentals and Practice

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Publisher : Springer
ISBN 13 : 3319548026
Total Pages : 239 pages
Book Rating : 4.3/5 (195 download)

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Book Synopsis Regulated Bioanalysis: Fundamentals and Practice by : Mario L. Rocci Jr.

Download or read book Regulated Bioanalysis: Fundamentals and Practice written by Mario L. Rocci Jr. and published by Springer. This book was released on 2017-04-24 with total page 239 pages. Available in PDF, EPUB and Kindle. Book excerpt: The editors have engaged leading scientists in the field to participate in the development of this book, which is envisioned as a “one of a kind” contribution to the field. The book is a comprehensive text that puts fundamental bioanalytical science in context with current practice, its challenges and ongoing developments. It expands on existing texts on the subject by covering regulated bioanalysis of both small and large molecule therapeutics from both a scientific and regulatory viewpoint. The content will be useful to a wide spectrum of readers: from those new to bioanalysis; to those developing their experience in the laboratory, or working in one of the many critical supporting roles; to seasoned practitioners looking for a solid source of information on this exciting and important discipline.

The ASQ Certified Supplier Quality Professional Handbook

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Author :
Publisher : Quality Press
ISBN 13 : 1636941214
Total Pages : 323 pages
Book Rating : 4.6/5 (369 download)

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Book Synopsis The ASQ Certified Supplier Quality Professional Handbook by : Mark Allen Durivage

Download or read book The ASQ Certified Supplier Quality Professional Handbook written by Mark Allen Durivage and published by Quality Press. This book was released on 2023-11-15 with total page 323 pages. Available in PDF, EPUB and Kindle. Book excerpt: This handbook explains, in detail, each section of the Certified Supplier Quality Professional Body of Knowledge (updated 2023). It is a handy reference for those already working in the field and is an essential text for those working toward a CSQP certification.

360 Degree Feedback and Assessment and Development Centres

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Publisher : Excel Books India
ISBN 13 : 9788174464149
Total Pages : 356 pages
Book Rating : 4.4/5 (641 download)

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Book Synopsis 360 Degree Feedback and Assessment and Development Centres by : Rao

Download or read book 360 Degree Feedback and Assessment and Development Centres written by Rao and published by Excel Books India. This book was released on 2009 with total page 356 pages. Available in PDF, EPUB and Kindle. Book excerpt: 360 Degree Feedback, often used in tandem with Assessment and Development Centres, is a powerful technique pioneered in India by TV Rao Learning Systems, who have over the last five years applied this very successfully to many of India's large companies.This volume, the third and last in the series, is an indispensable corollary and companion to the second volume, in as much as the focus is on Leadership Development, one of the most urgently felt needs of the Corporate sector. Spurred on by the threats and opportunities of global competition, companies are now focusing on developing talented leaders. This book, in mapping the terrain and the strategies needed to compete, focuses inter alia on:l Assessment Centresl New Case Studies Pertaining to Top Indian Corporatesl Critical essays pertaining to Competency Mapping, 360 Degree Feedback, Assessment Centres, and Mergers & Acquisitionsl In-house Work by Organizations without outside AssistanceThese vital issues explored in elaborate detail in this book will be appreciated not only by practicing HR professionals and senior executives, but also by management students.

Pharmaceutical Computer Systems Validation

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Publisher : CRC Press
ISBN 13 : 1420088955
Total Pages : 773 pages
Book Rating : 4.4/5 (2 download)

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Book Synopsis Pharmaceutical Computer Systems Validation by : Guy Wingate

Download or read book Pharmaceutical Computer Systems Validation written by Guy Wingate and published by CRC Press. This book was released on 2016-04-19 with total page 773 pages. Available in PDF, EPUB and Kindle. Book excerpt: Thoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification principles and how to put them into practice. To provide the current best practice and guidance on identifying and implementing improvements for computer systems, the text extensively reviews regulations of pharmaceuticals, healthcare products, blood processing, medical devices, clinical systems, and biotechnology. Ensuring that organizations transition smoothly to the new system, this guide explains how to implement the new GMP paradigm while maintaining continuity with current practices. In addition, all 24 case studies from the previous edition have been revised to reflect the new system.

Building a World-Class Compliance Program

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Publisher : John Wiley & Sons
ISBN 13 : 0470278404
Total Pages : 320 pages
Book Rating : 4.4/5 (72 download)

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Book Synopsis Building a World-Class Compliance Program by : Martin T. Biegelman

Download or read book Building a World-Class Compliance Program written by Martin T. Biegelman and published by John Wiley & Sons. This book was released on 2008-06-20 with total page 320 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written by a long-standing practitioner in the field, this timely and critical work is your best source for understanding all the complex issues and requirements associated with corporate compliance. It provides clear guidance for those charged with protecting their companies from financial and reputational risk, litigation, and government intervention, who want a robust guide to establish an effective compliance program.

Managing Social and Economic Change with Information Technology

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Publisher : IGI Global
ISBN 13 : 9781878289261
Total Pages : 564 pages
Book Rating : 4.2/5 (892 download)

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Book Synopsis Managing Social and Economic Change with Information Technology by : Information Resources Management Association. International Conference

Download or read book Managing Social and Economic Change with Information Technology written by Information Resources Management Association. International Conference and published by IGI Global. This book was released on 1994-01-01 with total page 564 pages. Available in PDF, EPUB and Kindle. Book excerpt: Many experts believe that through the utilization of information technology, organizations can better manage social and economic change. This book investigates the challenges involved in the use of information technologies in managing these changes.

Regulatory Guide

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Publisher :
ISBN 13 :
Total Pages : 148 pages
Book Rating : 4.F/5 ( download)

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Book Synopsis Regulatory Guide by : U.S. Nuclear Regulatory Commission. Office of Standards Development

Download or read book Regulatory Guide written by U.S. Nuclear Regulatory Commission. Office of Standards Development and published by . This book was released on 1979 with total page 148 pages. Available in PDF, EPUB and Kindle. Book excerpt: Contents: 1. Power reactors.--2. Research and test reactors.--3. Fuels and materials facilities.--4. Environmental and siting.--5. Materials and plant protection.--6. Products.--7. Transportation.--8. Occupational health.--9. Antitrust reviews.--10. General.

The Care Quality Commission

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Publisher : The Stationery Office
ISBN 13 : 9780215043399
Total Pages : 72 pages
Book Rating : 4.0/5 (433 download)

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Book Synopsis The Care Quality Commission by : Great Britain: Parliament: House of Commons: Committee of Public Accounts

Download or read book The Care Quality Commission written by Great Britain: Parliament: House of Commons: Committee of Public Accounts and published by The Stationery Office. This book was released on 2012-03-30 with total page 72 pages. Available in PDF, EPUB and Kindle. Book excerpt: The NAO report on this topic published as HC 1665, session 2010-12 (ISBN 9780102977011)

Quality Assurance Policies & Procedures for Ambulatory Health Care

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Author :
Publisher : Jones & Bartlett Learning
ISBN 13 : 9780834201385
Total Pages : 372 pages
Book Rating : 4.2/5 (13 download)

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Book Synopsis Quality Assurance Policies & Procedures for Ambulatory Health Care by : Judith M. Bulau

Download or read book Quality Assurance Policies & Procedures for Ambulatory Health Care written by Judith M. Bulau and published by Jones & Bartlett Learning. This book was released on 1990 with total page 372 pages. Available in PDF, EPUB and Kindle. Book excerpt: This manual is a comprehensive quality assurance resource applicable for use in various health care systems, such as ambulatory care settings, HMOs, PPOs, and by primary care providers, specialty providers, and regulatory agencies. Quality Assurance Policies & Procedures for Ambulatory Health Care enables these ambulatory health care systems to develop appropriate quality assurance programs and assists them in reviewing, supplementing, or revising existing quality assurance programs. Clear and concise, with step-by-step procedures for implementing each policy. It includes more than 100 sample forms, reports, letters, job descriptions, and other practical tools to save time and increase efficiency.

Point-of-care testing

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Publisher : Springer
ISBN 13 : 3662544970
Total Pages : 451 pages
Book Rating : 4.6/5 (625 download)

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Book Synopsis Point-of-care testing by : Peter Luppa

Download or read book Point-of-care testing written by Peter Luppa and published by Springer. This book was released on 2018-07-18 with total page 451 pages. Available in PDF, EPUB and Kindle. Book excerpt: The underlying technology and the range of test parameters available are evolving rapidly. The primary advantage of POCT is the convenience of performing the test close to the patient and the speed at which test results can be obtained, compared to sending a sample to a laboratory and waiting for results to be returned. Thus, a series of clinical applications are possible that can shorten the time for clinical decision-making about additional testing or therapy, as delays are no longer caused by preparation of clinical samples, transport, and central laboratory analysis. Tests in a POC format can now be found for many medical disciplines including endocrinology/diabetes, cardiology, nephrology, critical care, fertility, hematology/coagulation, infectious disease and microbiology, and general health screening. Point-of-care testing (POCT) enables health care personnel to perform clinical laboratory testing near the patient. The idea of conventional and POCT laboratory services presiding within a hospital seems contradictory; yet, they are, in fact, complementary: together POCT and central laboratory are important for the optimal functioning of diagnostic processes. They complement each other, provided that a dedicated POCT coordination integrates the quality assurance of POCT into the overall quality management system of the central laboratory. The motivation of the third edition of the POCT book from Luppa/Junker, which is now also available in English, is to explore and describe clinically relevant analytical techniques, organizational concepts for application and future perspectives of POCT. From descriptions of the opportunities that POCT can provide to the limitations that clinician’s must be cautioned about, this book provides an overview of the many aspects that challenge those who choose to implement POCT. Technologies, clinical applications, networking issues and quality regulations are described as well as a survey of future technologies that are on the future horizon. The editors have spent considerable efforts to update the book in general and to highlight the latest developments, e.g., novel POCT applications of nucleic acid testing for the rapid identification of infectious agents. Of particular note is also that a cross-country comparison of POCT quality rules is being described by a team of international experts in this field.