Pazhayattil (69 risultati)

Condizione: New. In English.

Condizione: As New. Unread book in perfect condition.

Condizione: New. In English.

Hardcover. Condizione: new. Hardcover. This book tackles the crucial topic of deviation and failure investigations in the pharmaceutical industry, recognizing their pivotal influence on regulatory outcomes. Extensive assessments, including analyses of US FDA warning letters and 483 reports, underscore the indispensable necessity of a robust investigation. The textbook thoroughly explores the standard tools and techniques for conducting scientifically grounded and data-driven investigations. Its overarching objective is to elucidate systematic investigation methodologies that yield effective corrective and preventive actions, ultimately reducing regulatory risks. This book offers a comprehensive overview of standard tools and techniques, focusing on science-based and data-driven approaches. Tailored for professionals in pharmaceutical manufacturing, this book is your go-to resource for mastering investigations in the manufacturing of patient-critical pharmaceutical products. This book tackles the crucial topic of deviation and failure investigations in the pharmaceutical industry, recognizing their pivotal influence on regulatory outcomes. Shipping may be from multiple locations in the US or from the UK, depending on stock availability. …

Condizione: New.

Condizione: As New. Unread book in perfect condition.

Condizione: As New. Unread book in perfect condition.

Condizione: New.

Condizione: New.

Condizione: New.

Hardcover. Condizione: Brand New. 165 pages. 9.25x6.10x9.44 inches. In Stock.

Condizione: New.

Condizione: New. A brand new book in pristine condition. Showing zero signs of shelf wear, creases, or damage.

Taschenbuch. Condizione: Neu. Druck auf Anfrage Neuware - Printed after ordering - This book tackles the crucial topic of deviation and failure investigations in the pharmaceutical industry, recognizing their pivotal influence on regulatory outcomes. Extensive assessments, including analyses of US FDA warning letters and 483 reports, underscore the indispensable necessity of a robust investigation. The textbook thoroughly explores the standard tools and techniques for conducting scientifically grounded and data-driven investigations. Its overarching objective is to elucidate systematic investigation methodologies that yield effective corrective and preventive actions, ultimately reducing regulatory risks. This book offers a comprehensive overview of standard tools and techniques, focusing on science-based and data-driven approaches. Tailored for professionals in pharmaceutical manufacturing, this book is your go-to resource for mastering investigations in the manufacturing of patient-critical pharmaceutical products.…

Condizione: New. In English.

Condizione: New.

Condizione: New.

Condizione: New.

Condizione: As New. Unread book in perfect condition.

Condizione: New.

Taschenbuch. Condizione: Neu. Pharmaceutical Manufacturing Deviation and Failure Investigations | Principles, Practices, and Case Studies | Ajay Babu Pazhayattil (u. a.) | Taschenbuch | AAPS Introductions in the Pharmaceutical Sciences | xiii | Englisch | 2026 | Springer | EAN 9783031865060 | Verantwortliche Person für die EU: Springer Verlag GmbH, Tiergartenstr. 17, 69121 Heidelberg, juergen[dot]hartmann[at]springer[dot]com | Anbieter: preigu.…

Hardcover. Condizione: Brand New. 122 pages. 9.25x6.10x0.51 inches. In Stock.

Condizione: New. 2023rd edition NO-PA16APR2015-KAP.

Condizione: New. 1st ed. 2018 edition NO-PA16APR2015-KAP.

Buch. Condizione: Neu. Druck auf Anfrage Neuware - Printed after ordering - This book tackles the crucial topic of deviation and failure investigations in the pharmaceutical industry, recognizing their pivotal influence on regulatory outcomes. Extensive assessments, including analyses of US FDA warning letters and 483 reports, underscore the indispensable necessity of a robust investigation. The textbook thoroughly explores the standard tools and techniques for conducting scientifically grounded and data-driven investigations. Its overarching objective is to elucidate systematic investigation methodologies that yield effective corrective and preventive actions, ultimately reducing regulatory risks. This book offers a comprehensive overview of standard tools and techniques, focusing on science-based and data-driven approaches. Tailored for professionals in pharmaceutical manufacturing, this book is your go-to resource for mastering investigations in the manufacturing of patient-critical pharmaceutical products.…

Taschenbuch. Condizione: Neu. Druck auf Anfrage Neuware - Printed after ordering - Currently, there are no textbooks on drug product manufacturing technology transfer that incorporate the latest regulatory expectations. Recent guidance from regulatory bodies such as the US FDA, EMEA, WHO, and PIC/S has adopted the ICH Lifecycle approach harmonizing concepts across regulatory guidance. This allows organizations to align their technology transfer activities for all regulated markets. However, there is a need for consensus and direction in approaching technology transfer, particularly in understanding how to manage the scale-up effects to ensure regulatory compliance.This textbook offers technology transfer solutions and guidance to the pharmaceutical industry. The chapters provide a systematic understanding of applying the technology transfer concepts in pharmaceutical manufacturing, promoting standardization within the industry. Since Stage 1b is not specified in detail within the regulations, pharmaceutical organizations are left to determine the requirementsof the stage. The need to justify the methodologies and utilization of sound science makes it more demanding. The textbook's authors provide innovative solutions for technology transfer challenges, making it a comprehensive reference document. The approaches can be applied to both small-molecule and large-molecule drug product manufacturing segments, addressing the unmet needs of the industry.…

Condizione: New.

Hardcover. Condizione: Brand New. 165 pages. 9.25x6.10x9.44 inches. In Stock.

Condizione: New. In English.

Condizione: New.