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Technical Report 40: Sterilizing Filtration of Gases (paper ship version)
Book
The first report, Sterilizing Filtration of Gases, is prepared by PDA Sterile Gas Filtration Committee. The objective of the report is to assist the reader in the selection, qualification and validation of a filter that is appropriate for the application on hand. In this report, sterilizing filtration … -
Essential Microbiology for QP Candidates (Hardcover)
Book
This book has been prepared to address the requirements which are stated in the Guide to the Knowledge and Practical Experience Required by Qualified Persons in the Pharmaceutical Industry (the "Study Guide") in relation to pharmaceutical microbiology.This reference guide will help QP candidates … -
Conducting Compliant Investigations
Book
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 … -
Digital Transformation and Regulatory Considerations for Biopharmaceutical and Healthcare Manufacturers, Volume 1: Digital Technologies for Automation and Process Improvement
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 … -
Root Cause Investigations for CAPA: Clear and Simple
Book
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 … -
Software as a Service (SaaS): Risk-Based Validation with Time-Saving Templates
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
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 … -
FDA Warning Letters: Analysis and Guidance
Book
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 … -
Fungi: A Handbook for Life Science Manufacturers and Researchers
Book
This text can help identify and ameliorate fungal and mold problems and contains a wealth of information as a guide and reference. Many topics are discussed relevant to the food and agriculture industries, including the biology of fungi, outbreaks associated with pharmaceutical drug products and medical … -
Biotechnology: From Idea to Market
Book
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 … -
Audit and Control for Healthcare Manufacturers: A Systems-Based Approach
Book
Audits are an important part of quality assurance and the quality management system. With the help of PDA's newest book, Audit and Control for Healthcare Manufacturers: A Systems-Based Approach, you can ensure the quality and effectiveness of your processes, systems, and personnel is maintained throughout … -
Microbiology in Pharmaceutical Manufacturing, Second Edition, Revised and Expanded, Volume 2
Book
Clearance Sale - 20% off! Original Price US$235 PDA Member, US$289 Nonmember, US$155 Government Sale prices are already displayed and will be reflected during checkoutThe first edition of Microbiology in Pharmaceutical Manufacturing, published in 2001, is THE best selling PDA/DHI book of all time. … -
Contamination Control in Healthcare Product Manufacturing, Volume 5
Book
The fifth volume to PDA's popular series, Contamination Control in Healthcare Product Manufacturing, explores practical approaches to leverage environmental monitoring data to improve performance, how to design a risk-based environmental monitoring program for non-sterile manufacturing, the clinical … -
GMP in Practice: Regulatory Expectations for the Pharmaceutical Industry, Fifth Edition, Revised & Expanded
Book
The Long-Awaited Revision and Update of GMP in Practice is Here! Have you ever asked yourself, "Where in the Good Manufacturing Practices (GMPs) does it say I have to do _______?" If so, look no further than PDA's GMP in Practice: Regulatory Expectations for the Pharmaceutical Industry, fifth … -
Contamination Prevention for Nonsterile Pharmaceutical Manufacturing
Book
The handbook on Contamination Prevention for Nonsterile Pharmaceutical Manufacturing offers guide-lines for best practices to be deployed within a manufacturing facility. It explains where the most common microbiological risks to nonsterile manufacturing reside and how to prevent contamination in the … -
PDA Technical Report No. 29, Revised 2012 (TR 29) Points to Consider for Cleaning Validation
Book
It has been 14 years since PDA published the original Technical Report No. 29, and cleaning validation continues to play an important role in reducing the possibility of product contamination from pharmaceutical manufacturing equipment. Cleaning validation demonstrates that the cleaning process adequately … -
Technical Report No. 40, (TR 40): Sterilizing Filtration of Gases
Book
The first report, Sterilizing Filtration of Gases, is prepared by PDA Sterile Gas Filtration Committee. The objective of the report is to assist the reader in the selection, qualification and validation of a filter that is appropriate for the application on hand. In this report, sterilizing filtration … -
PDA Technical Report No. 28 Revised, (TR 28) Process Simulation Testing for Sterile Bulk Pharmaceutical Chemicals
Book
This Technical Report was prepared by the Joint PDA/PhRMA Sterile Bulk Pharmaceutical Chemicals Task Force. This document provides guidance relative to the validation of aseptic processing activities utilized for the production of sterile bulk pharmaceutical chemicals. It draws upon the concepts … -
PDA Technical Report No. 15, Revised 2009 (TR 15) Validation of Tangential Flow Filtration in Biopharmaceutical Applications
Book
This Technical Report was prepared by members of the PDA Validation of Tangential Flow Filtration in Biopharmaceutical Applications Task Force. PDA Technical Report No. 15 (Revised 2009): Validation of Tangential Flow Filtration in Biopharmaceutical Applications, updates the 1992 original version … -
Validating Enterprise Systems: A Practical Guide
Book
Sale - 20% off! Original Price US$225 PDA Member, US$279 Nonmember, US$175 Government Sale prices are already displayed and will be reflected during checkoutHere is a book that one peer reviewer called "brilliant." Written by a well-know subject matter expert, this book describes the latest tools, techniques …
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