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Digital Transformation and Regulatory Considerations for Biopharmaceutical and Healthcare Manufacturers: Digital Technologies for Automation and Process Improvement (Hardcover)
Book
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 … -
Water Activity Applications in the Pharmaceutical Industry (single user digital version)
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This book examines the fundamentals and relationships of water activity, ranging from the measurement of moisture content, water activity, and water sorption isotherms, to ways in which water activity affects microorganisms, chemical reaction rates, drug product formulation and processing and physical … -
PDA Technical Report No. 84 (TR 84) Integrating Data Integrity Requirements into Manufacturing & Packaging Operations (single user digital version)
PDF Single user
PDA Technical Report No. 84 (TR 84): Integrating Data Integrity Requirements into Manufacturing and Packaging Operations addresses data integrity from the perspective of manufacturing operations. It discusses regulatory trends, risk management concepts, and recommendations for implementing appropriate … -
Points to Consider for Implementation of Pre-Use Post-Sterilization Integrity Testing (PUPSIT) (single user digital version)
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This Points to Consider document was developed as part of the PDA/BioPhorum Sterilizing Filtration Quality Risk Management Consortium. It provides the reader with points to consider on how to best implement and execute a pre-use/post-sterilization integrity test (PUPSIT) of the final sterilizing grade … -
Points to Consider for Risks Associated with Sterilizing Grade Filters and Sterilizing Filtration (single user digital version)
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PDA's Points to Consider for Risks Associated with Sterilizing Grade Filters and Sterilizing Filtration summarizes the processes and outcomes of the risk Assessment and control mapping exercises performed as part of the PDA/BioPhorum Sterilizing Filtration Quality Risk Management Consortium. It describes … -
Root Cause Investigations for CAPA: Clear and Simple (single user digital version)
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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 … -
Points to Consider for the Aseptic Processing of Sterile Pharmaceutical Products in Isolators
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Focusing on important regulatory and technical updates surrounding isolator design, validation, and operations for aseptic processing, this Points to Consider addresses two primary types of isolators - open and closed - and is intended to support identification and use of modern technology. It does not … -
Software as a Service (SaaS): Risk-Based Validation with Time-Saving Templates (single user digital version)
PDF Single user
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 … -
Software as a Service (SaaS): Risk-Based Validation with Time-Saving Templates (Hardcover)
Book
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 … -
Recalls of Pharmaceutical Products: Eliminating Contamination and Adulteration Causes (Hardcover)
Book
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 … -
ANSI/PDA Standard 001-2020: Enhanced Purchasing Controls to Support the Bio-Pharmaceutical, Pharmaceutical, Medical Devices and Combination Products Industries (single user digital version)
PDF Single user
A standard guidance for the selection and control of suppliers of purchased goods and services that can impact product quality and patient safety. Available to download Format: PDF (1 file 703 KB)Click here to view the digital downloading instruction and Terms of … -
5 Year Summary of FDA Medical Device 483s: 2015-2019 (single user digital version)
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The form FDA 483, "Inspectional Observations," is a form used by the FDA to document and communicate concerns discovered during the inspections of medical device manufacturing plants. This booklet takes the publicly available yearly inspection data from the U.S. FDA and presents it in a more … -
5 Year Summary of FDA Drug 483s: 2015-2019 (single user digital version)
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This publication provides a summary and analysis of publicly available yearly observation data for drug product manufacturers from the U.S. FDA and presents it in a more useful, digestible format. It includes an analysis of trends in observations and a breakdown of the most common observations from … -
5 Year Summary of FDA Biologics 483s: 2015-2019 (single user digital version)
PDF Single user
The form FDA 483, "Inspectional Observations," is a form used by the FDA to document and communicate concerns discovered during the inspections of biological manufacturing plants. This booklet takes the publicly available yearly inspection data from the U.S. FDA and presents it in a more useful, … -
Managing the Pharmaceutical Cold Chain (single user digital version)
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This chapter is reprinted and available individually from Good Distribution Practice: A Handbook for Healthcare Manufacturers and Suppliers, Volume 1 edited by Siegfried Schmitt, a text that collects in one place invaluable and comprehensive regulatory, manufacturing and distribution guidance and … -
Toward an Integrated Cold Chain (single user digital version)
PDF Single user
This chapter is reprinted and available individually from Good Distribution Practice: A Handbook for Healthcare Manufacturers and Suppliers, Volume 1 edited by Siegfried Schmitt, a text that collects in one place invaluable and comprehensive regulatory, manufacturing and distribution guidance and … -
Serialisation Regulations in the EU and USA (single user digital version)
PDF Single user
This chapter is reprinted and available individually from Good Distribution Practice: A Handbook for Healthcare Manufacturers and Suppliers, Volume 1 edited by Siegfried Schmitt, a text that collects in one place invaluable and comprehensive regulatory, manufacturing and distribution guidance and … -
Key Features of a Biosafety Program for the Biopharmaceutical Industry (single user digital version)
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Here are robust discussions of microbial identifications in a new light.This reprint from Microbial Control and Identification: Strategies, Method and Applications edited by Dona Reber and Mary Griffin demonstrate how microbial identification knowledge is a cornerstone in the concept of microbial and … -
Overview of Conventional and Emerging Microbial Identification Methods (single user digital version)
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Here are robust discussions of microbial identifications in a new light.This reprint from Microbial Control and Identification: Strategies, Method and Applications edited by Dona Reber and Mary Griffin demonstrate how microbial identification knowledge is a cornerstone in the concept of microbial and … -
Quality Control Testing Throughout the Product Development Lifecycle (single user digital version)
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Building Value into Biotechnology Development and ManufacturingThe magnitude of knowledge and experience required to have a meaningful impact on biotechnology product approvals and market success is monumental. For the first time, expertly crafted chapter is reprinted from Biotechnology From Idea to …
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