Bookstore Search
Refine Results
Sorted By: Relevance | Most Recent
- Books (172)
- Technical Reports (122)
- Surveys (23)
- Standards (4)
-
Digital Transformation and Regulatory Considerations for Biopharmaceutical and Healthcare Manufacturers, Volume 2: Digital Data, Insights, Metrics and Analytics (single user digital version)
PDF Single user
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 … -
Reporte Tecnico No. 1 (Revisado en 2007) Validacion de los Procesos de Esterilizacion por Calor Humedo: Diseno del Ciclo, Desarrollo, Calificacion y Control Continuo (versión digital de un solo usuario)
PDF Usuario Unico
La Monografìa Técnica No. 1 original de PDA, Validación de los Ciclos de Esterilización por Vapor, publicada en 1978, introdujo los principios de la esterilización por vapor a una generación entera de cientìficos e ingenieros farmacéuticos. La revisión mantiene un enfoque en microbiologìa e ingenierìa … -
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)
PDF Single user
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)
PDF Single user
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)
PDF Single user
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)
PDF Single user
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)
PDF Single user
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 … -
Points to Consider for Sensitivity to Oxidation by Peroxide (single user digital version)
PDF Single user
PDA's Points to Consider for Sensitivity to Oxidation by Peroxide addresses aspects to consider in the design, development, processing, instrumentation, materials, and equipment specific to issues with products sensitive to oxidation when exposed to H2O2. This document primarily applies to isolator … -
Root Cause Investigations for CAPA: Clear and Simple (single user digital version)
PDF Single user
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
PDF Single user
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 (single user digital version)
PDF Single user
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 … -
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)
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 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)
PDF Single user
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, …
Please sign in or become a member to purchase items from the PDA bookstore.
Expert Training from PDA
Get in-depth, hands-on training on the hot industry topics addressed in our technical publications!
Learn MorePDA Journal Institutional Subscriptions
Share the PDA Journal with your entire organization! Purchase an Institutional Subscription and gain unlimited access to Journal content to multiple people within the same organization.
Request InformationTechnical Document Portal Access
Your company can subscribe to the PDA Technical Document Portal for institutional access to nearly 100 Technical Reports and Points to Consider documents!
Request Information