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**PRE-SALE! Full title will be released on 10/2/24**Companies producing sterile drug products must remain compliant with all regulations and requirements for current good manufacturing practices (cGMP) for any country or region where they wish to manufacture and market their products. Each regulatory …

Within the pharmaceutical and healthcare sector, validation and qualification form an important part of the quality system. However, understanding the differences between different regulatory agencies and the recommendations of different standards can be a bewildering project. This book seeks to …

An in-depth comprehensive survey of QC pharma methods in the microbiology laboratory to enable a better understanding of these methods, and to ensure better developed, more compliant, expedited procedures.The reference text brings together the hitherto unavailable background, fundamental …

The contamination control of pharmaceutical and healthcare environments and processes, together with pre-clinical drug development labs, requires a far more holistic approach than simply choosing technologies and disinfectants. Today the microbiologist is expected to understand industrial processes …

In this book you will find many different approaches to conducting compliant investigations, where compliant is defined as meeting the requirements of the applicable regulatory documents. The information it provides on conducting investigations that will be acceptable to regulatory investigators will …

PDA's book, Quality by Design — An Indispensable Approach to Accelerate Biopharmaceutical Product Development, edited by industry experts Cristiana Campa, Vaccines Technical R&D, GSK, and M. Amin Khan , Vaccines R&D, GSK, is an important contribution to the ongoing dialogue for accelerating …

This timely and informative text discusses aspects of contamination control in cleanrooms seldom described in detail in the literature. The increasing number of warning letters, product recalls and 483 observations related to both particulate and microbial contamination indicates that contamination control …

This second of two volumes details how pharmaceutical and healthcare manufacturers have ben embracing digital technologies as part of the transformation of their business models. It contextualizes current developments and future advancements in terms of the COVID-19 situation of 2020 and specific measures …

This second of two volumes details how pharmaceutical and healthcare manufacturers have ben embracing digital technologies as part of the transformation of their business models. It contextualizes current developments and future advancements in terms of the COVID-19 situation of 2020 and specific measures …

This first-of-two volume release from prolific author Tim Sandle fills an important void by taking an in-depth look at the way digital technologies are impacting the pharmaceutical and healthcare landscape both now and into the future. He explores how companies have been embracing digital technologies …

This first-of-two volume release from prolific author Tim Sandle fills an important void by taking an in-depth look at the way digital technologies are impacting the pharmaceutical and healthcare landscape both now and into the future. He explores how companies have been embracing digital technologies …

This text, based on workshops led by instructor and author James Vesper, provides practical tools for both a thorough understanding of risk-based CAPA investigations and regulatory acceptable applications.Beginning with topics such as why and how much investigations matter, regulatory requirements, roles …

From this book, you will learn a systematic, step-by-step approach for validating configurable off-the-shelf software that generates data or controls information about products and processes subject to regulations. You will also get access to templates the authors have used as training tools for more …

Are you prepared for recalls relating to pharmaceutical and healthcare medications and medical devices? This book contains details about recalls from start to finish, including advice on how to handle a recall and, more importantly, how they can be avoided. Read about regulatory perspectives, trends …

The best way to handle Warning Letters issued by the U.S. FDA is to prevent them. This text identifies and discusses those Letters recently issued, offers analysis, and provides guidance to help readers avoid receiving such a letter.In addition to the Warning Letter summaries there is discussion of …

PDA's latest professional resource, Biotechnology: From Idea to Market, is an invaluable guide and reference for anyone involved in the development of a product, from idea generation through commercialization. The goal of this book is to provide this comprehensive overview for students and professionals …

This timely and informative text discusses aspects of contamination control in cleanrooms seldom described in detail in the literature. The increasing number of warning letters, product recalls and 483 observations related to both particulate and microbial contamination indicates that contamination control …

PDA's book, Quality by Design — An Indispensable Approach to Accelerate Biopharmaceutical Product Development, edited by industry experts Cristiana Campa, Vaccines Technical R&D, GSK, and M. Amin Khan , Vaccines R&D, GSK, is an important contribution to the ongoing dialogue for accelerating …

This timely and informative text discusses aspects of contamination control in cleanrooms seldom described in detail in the literature. The increasing number of warning letters, product recalls and 483 observations related to both particulate and microbial contamination indicates that contamination …

This text, based on workshops led by instructor and author James Vesper, provides practical tools for both a thorough understanding of risk-based CAPA investigations and regulatory acceptable applications.Beginning with topics such as why and how much investigations matter, regulatory requirements, roles …