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Conducting Compliant Investigations (single user digital version)
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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 … -
The Infamous Fungus: Enigmatic, Distinct and Misjudged (single user digital version)
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This chapter is taken from the book Fungi: A Handbook for Life Science Manufacturers and Researchers, edited by Jeanne Moldenhauer.There is a major gap in understanding fungi in general and mold specifically in the pharmaceutical industry. Most mycologists are in academia and fungi are not taught in … -
Quality by Design - An Indispensable Approach to Accelerate Biopharmaceutical Product Development (single user digital version)
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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 … -
PDA Technical Report No. 60-3 (TR 60-3) Process Validation: A Lifecycle Approach, Annex 2: Biopharmaceutical Drug Substances Manufacturing (single user digital version)
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The concepts presented in PDA Technical Report No. 60-3 (TR 60-3): Process Validation: A Lifecycle Approach Annex 2: Biopharmaceutical Drug Substances Manufacturing are intended to assist in the design and implementation of globally compliant validation programs to ensure process reproducibility and … -
Digital Transformation and Regulatory Considerations for Biopharmaceutical and Healthcare Manufacturers, Volume 2: Digital Data, Insights, Metrics and Analytics (single user digital version)
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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 … -
PDA Technical Report No. 13-2 (TR 13-2) Fundamentals of an Environmental Monitoring Program Annex 1: Environmental Monitoring of Facilities Manufacturing Low Bioburden Products (single user digital version)
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PDA Technical Report No. 13-2 (TR 13-2) Fundamentals of an Environmental Monitoring Program Annex 1: Environmental Monitoring of Facilities Manufacturing Low Bioburden Products, is an addendum to PDA Technical Report No. 13 (TR 13, Revised 2014): Fundamentals of an Environmental Monitoring Program, which … -
Digital Transformation and Regulatory Considerations for Biopharmaceutical and Healthcare Manufacturers, Volume 1: Digital Technologies for Automation and Process Improvement (single user digital version)
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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 … -
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 … -
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 … -
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)
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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 … -
5 Year Summary of FDA Biologics 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 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)
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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 … -
Serialisation Regulations in the EU and USA (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 … -
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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