
Bookstore Search
Refine Results
Sorted By: Relevance | Most Recent
- Books (64)
- Technical Reports (48)
- Surveys (4)
-
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 … -
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 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 … -
FDA Warning Letters: Analysis and Guidance (single user digital version)
PDF Single user
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 (single user digital version)
PDF Single user
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 … -
PDA Research: 2019 Sterile Lyophilized Drug Product Loading Survey (single user digital version)
PDF Single user
This survey is designed to align and expand PDA's insight on current practices for companies that manufacture sterile lyophilized drug products and conduct lyophilizer loading. It also provides insight into how today's lyophilizer loading area operations can be improved to reduce contamination from … -
Contamination Control in Healthcare Product Manufacturing, Volume 5 (single user digital version)
PDF Single user
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 … -
PDA Research: 2017 PDA PUPSIT Survey (single user digital version)
PDF Single user
In March of 2017, PDA conducted a benchmarking survey to better understand the current situation regarding sterile filtration and the implementation of Pre-Use Post Sterilization Integrity Test, or PUPSIT, among large pharmaceutical companies. Due to increased enforcement of section 113 of Annex 1 by … -
PDA Research: 2017 PDA Aseptic Processing Survey (single user digital version)
PDF Single user
The 2017 PDA Aseptic Processing Survey explores aseptic processing practices for global secondary manufacturing (finished product filling/packaging), while taking into consideration the changes and needs of the modern, global, sterile, healthcare product manufacturing industry. Results are based on 304 … -
Microbiological Culture Media: A Complete Guide for Pharmaceutical and Healthcare Manufacturers (single user digital version)
PDF Single user
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 … -
Torbeck`s Statistical Cookbook for Scientists and Engineers (single user digital version)
PDF Single user
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 … -
Torbeck`s Statistical Cookbook for Scientists and Engineers (Hardcover)
Book
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 … -
Environmental Monitoring: A Comprehensive Handbook, Volume 8 (single user digital version)
PDF Single user
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 … -
Environmental Monitoring: A Comprehensive Handbook, Volume 8 (Hardcover)
Book
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 … -
Aseptic and Sterile Processing: Control, Compliance and Future Trends (single user digital version)
PDF Single user
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 … -
Cleaning Validation: Practical Compliance Solutions for Pharmaceutical Manufacturing, Volume 3 (single user digital version)
PDF Single user
Sale - 20% off! Original Price US$265 PDA Member, US$329 Nonmember, US$180 Government Sale prices are already displayed and will be reflected during checkoutIn Destin LeBlanc's Cleaning Validation: Practical Compliance Solutions for Pharmaceutical Manufacturing, Vol. 3 pharmaceutical manufacturers and … -
Cleaning Validation: Practical Compliance Solutions for Pharmaceutical Manufacturing, Volume 2 (single user digital version)
PDF Single user
Sale - 20% off! Original Price US$265 PDA Member, US$329 Nonmember, US$180 Government Sale prices are already displayed and will be reflected during checkoutThis book complements Cleaning Validation: Practical Solutions for Pharmaceutical Manufacturing, Volume 1. It contains modifications and updates … -
Cleaning Validation: Practical Compliance Solutions for Pharmaceutical Manufacturing, Volume 1 (single user digital version)
PDF Single user
Sale - 20% off! Original Price US$265 PDA Member, US$329 Nonmember, US$180 Government Sale prices are already displayed and will be reflected during checkoutCleaning Validation: Practical Compliance Solutions for Pharmaceutical Manufacturing by Destin LeBlanc contains a complete, modified and updated … -
Sterilization: Practical Approaches (single user digital version)
PDF Single user
Pharmaceutical Manufacturing: Understanding Your Process Series Sterilization: Practical ApproachesIn the past 15 years, PDA/DHI has published more than 1,000 practical scientific and regulatory chapters, written by global subject matter experts, which have been designed to help pharmaceutical and … -
Sterilization: Establishing the Process (single user digital version)
PDF Single user
Pharmaceutical Manufacturing: Understanding Your Process Series Sterilization: Establishing the ProcessIn the past 15 years, PDA/DHI has published more than 1,000 practical scientific and regulatory chapters, written by global subject matter experts, which have been designed to help pharmaceutical …
Please sign in or become a member to purchase items from the PDA bookstore.