Medical Device Quality Assurance and Regulatory Compliance

Medical Device Quality Assurance and Regulatory Compliance
Author: Richard C. Fries
Publisher: CRC Press
Total Pages: 504
Release: 1998-08-11
Genre: Medical
ISBN: 9780824701772

"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."

The ASQ Certified Quality Auditor Handbook

The ASQ Certified Quality Auditor Handbook
Author: Lance B. Coleman
Publisher: Quality Press
Total Pages: 324
Release: 2020-02-01
Genre: Business & Economics
ISBN: 1951058119

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.

The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
Author: John Geigert
Publisher: Springer
Total Pages: 446
Release: 2019-05-08
Genre: Medical
ISBN: 3030137546

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.

Regulated Bioanalysis: Fundamentals and Practice

Regulated Bioanalysis: Fundamentals and Practice
Author: Mario L. Rocci Jr.
Publisher: Springer
Total Pages: 239
Release: 2017-04-24
Genre: Medical
ISBN: 3319548026

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.

360 Degree Feedback and Assessment and Development Centres

360 Degree Feedback and Assessment and Development Centres
Author: Rao
Publisher: Excel Books India
Total Pages: 356
Release: 2009
Genre: Employees
ISBN: 9788174464149

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.

The ASQ Certified Supplier Quality Professional Handbook

The ASQ Certified Supplier Quality Professional Handbook
Author: Mark Allen Durivage
Publisher: Quality Press
Total Pages: 323
Release: 2023-11-15
Genre: Business & Economics
ISBN: 1636941214

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.