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Clearance Sale - 20% off! Original Price US$225 PDA Member, US$279 Nonmember, US$180 Government Sale prices are already displayed and will be reflected during checkoutRisk-Based Software Validation: Ten Easy Steps, offers a systematic, ten-step approach, from the decision to validate to the assessment …

Following an introduction to the subject of Good Distribution Practice (GDP), in the second volume, dive into supply-chain risk mitigation, serialization, and packaging as it relates to risk assessments. This text and its companion Volume 1 will help drive down costs and improve efficiency.Available …

Following an introduction to the subject of Good Distribution Practice (GDP), the first volume of this book covers key topics related to five main points: the applicable GDP regulations worldwide, including serialization; an overview of the requirements of Qualified Persons and Responsible Persons in …

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 …

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 …

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 …

PDA Technical Series: Endotoxin Analysis and Risk Management is a collection of published research on the topic from the PDA Journal of Pharmaceutical Science and Technology. This volume is intended for those in the industry who perform and/or are responsible for the quality testing and manufacture of …

There are four simple sentences that define the concept of compliance and its relationship to Standard Operating Procedures (SOPs) — Say what you do. Do what you say. Prove it. Improve it. Despite this concept seeming simple, the number one topic of 483 observations for biologics, drugs, and devices …

Environmental monitoring programs are appropriate for manufacturing of sterile products and non-sterile products. The most stringent application of these procedures is for sterile products manufactured by aseptic processing, while less stringent procedures may be appropriately employed for terminally …

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. …

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. …

The PDA Technical Series: Pharmaceutical Glass is a collection of articles previously published in the PDA Journal of Pharmaceutical Science and Technology . This compilation organizes 19 articles on glass published between 2007 and 2017 into four categories: Overview, Material …

This book provides succinct and practical guidance on how to develop a biological drug product and, at the same time, stay within the regulatory expectations at each phase of the development process!Within this book, you can find chapters on:Current manufacturing and process development of Regenerative …

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 …

Taking into account that 90 percent of quality control microbiology remains reliant upon culture based methods, this unique text focuses on microbiological culture media as applied to pharmaceutical microbiology. This book takes into consideration that innovations continue to arise with new media recipes …

In the Statistical Cookbook for Scientists and Engineers, you will find tried and true, practical statistical "recipes" that provide a book of specific and unique statistical modules useful for evaluation of industrial studies. These modules are designed for the busy industrial worker, who needs to apply …

In the Statistical Cookbook for Scientists and Engineers, you will find tried and true, practical statistical "recipes" that provide a book of specific and unique statistical modules useful for evaluation of industrial studies. These modules are designed for the busy industrial worker, who needs to apply …

Volume 8 of the Environmental Monitoring Handbook series is a mixture of new topics and new takes on previously discussed topics. In this volume, you will find information about regulatory/compendial updates, testing methods, risk methods and tools, and routine (and non-routine) monitoring! This volume …

Volume 8 of the Environmental Monitoring Handbook series is a mixture of new topics and new takes on previously discussed topics. In this volume, you will find information about regulatory/compendial updates, testing methods, risk methods and tools, and routine (and non-routine) monitoring. This volume …

Here is the most important text discussing aseptic and sterile manufacturing to be published in the last decade that looks at both today and tomorrow in regard to these two vital processing procedures.The Editors realized that there was an urgent imperative for the relevant subjects to be reassessed …