
Bookstore Search
Refine Results
Sorted By: Relevance | Most Recent
- Books (129)
- Technical Reports (73)
- Surveys (12)
-
Introduction to Environmental Monitoring in Pharmaceutical Areas (single user digital version)
PDF Single user
Dr. Michael Jahnke, Head of Microbiology at Pharma Hameln GmbH, introduces you to the subject of environmental monitoring of pharmaceutical areas. Major topics covered include: Cleanrooms including discussions of zones, classifications, assignment of production rooms; Air-handling systems; Causes of … -
Media Fill Validation Environmental Monitoring During Aseptic Processing (single user digital version)
PDF Single user
The second in this series of four books. Provides current, practical techniques that focus on considerations in the preparation and monitoring of aseptic manufacturing, taking into account the national and international requirements, and guidelines concerning the validation of aseptic processing. The … -
Hosting a Compliance Inspection (single user digital version)
PDF Single user
Here is the guidance you need to host a compliance inspection. This book provides a common-sense approach for assessing an incoming inspection and preparing for it, regardless of who is conducting the inspection. Company and country cultures vary greatly, as do the regulations driving … -
The External Quality Audit (single user digital version)
PDF Single user
The companion to The Internal Quality Audit, this book performs the same valuable function by helping you focus on issues specific to your suppliers, contractors, and consultants. External audits help you ensure that each supplier consistently provides valuable services that enhance your … -
The Internal Quality Audit (single user digital version)
PDF Single user
Here is the common-sense guidance you need to perform an effective, systematic internal quality audit. As a quality professional, you are well aware of the repercussions caused by a nonconforming product entering the marketplace; customers may experience adverse effects or worse, and your company … -
Microbial Risk Assessment in Pharmaceutical Clean Rooms (single user digital version)
PDF Single user
This monograph clearly explains the Limitation of Risk Method (LR-Method). When a systematic risk analysis is performed and sampling locations are selected and evaluated in a rational manner using this method, comprehensive monitoring will reduce the number of microbiological samples necessary and provide … -
Microbiological Monitoring of Pharmaceutical Process Water (single user digital version)
PDF Single user
Following a discussion of the regulations to be followed in the microbiological control of water processing and distribution systems, this work focuses on practical aspects in the pharmaceutical environment and gives advice on the methodology to be used, e.g., for sampling, the selection of nutrient … -
Environmental Impact on Media Fills (single user digital version)
PDF Single user
This booklet was excerpted from Environmental Monitoring: A Comprehensive Handbook, Volume 2, edited by Jeanne Moldenhauer. Environmental Impact on Media Fills A two-week, hands-on Aseptic Processing Course has been offered annually since 1999 by PDA at their Training and Research Institute … -
Validation of Environmental Monitoring Methods (single user digital version)
PDF Single user
This booklet covers the below chapter that is taken from PDA's bestselling Laboratory Validation, and offers a complete overview of a specific topic and provides practical advice for anyone interested in current aspects of laboratory validation. Validation of Environmental Monitoring Methods … -
Using Statistics to Measure and Improve Quality (single user digital version)
PDF Single user
This booklet includes below chapter is taken from PDA's bestselling Pharmaceutical Quality, and offers an examination of quality from the perspectives of senior experts working in industry, government and academia from around the world. Using Statistics to Measure and Improve Quality This booklet … -
Validation of Microbial Identification Systems (single user digital version)
PDF Single user
This booklet covers the below chapter is taken from PDA's best selling Laboratory Validation, and offers a complete overview of a specific topic and provides practical advice for anyone interested in current aspects of laboratory validation.Validation of Microbial Identification Systems There are … -
Validation Procedures for the Bacterial Endotoxins Test (single user digital version)
PDF Single user
This booklet covers below chapter that is taken from PDA's bestselling Laboratory Validation, and offers a complete overview of a specific topic and provide practical advice for anyone interested in current aspects of laboratory validation. Validation Procedures for the Bacterial Endotoxins Test Bacterial … -
Validation of Sterilization Processes (single user digital version)
PDF Single user
This booklet covers the below chapter that is taken from PDA's bestselling Microbiology in Pharmaceutical Manufacturing, 1st Edition, and provides practical advice for anyone interested in current aspects of microbiology in pharmaceutical manufacturing. Validation of Sterilization Processes The goal … -
Training and Learning Critical Contributors to Quality (single user digital version)
PDF Single user
This booklet includes below chapter is taken from PDA's bestselling Pharmaceutical Quality , and offers an examination of quality from the perspectives of senior experts working in industry, government and academia from around the world. Training and Learning: Critical Contributors to Quality This … -
Microbiological Validation Master Plan (single user digital version)
PDF Single user
This booklet covers the below chapter that is taken from PDA's bestselling Microbiology in Pharmaceutical Manufacturing, 1st Edition and provides practical advice for anyone interested in current aspects of microbiology in pharmaceutical manufacturing. Microbiological Validation Master Plan This … -
Designing a Contamination Control Program (single user digital version)
PDF Single user
This booklet includes below chapter that is taken from PDA's bestselling Microbiology in Pharmaceutical Manufacturing, 1st Edition and provides practical advice for anyone interested in current aspects of microbiology in pharmaceutical manufacturing. Designing a Contamination Control Program This booklet … -
Validation of Rapid Methods and Systems and Validation of Sterility Test Suites and Isolators (single user digital version)
PDF Single user
This booklet covers the below 2 chapters is taken from PDA's bestselling Laboratory Validation, and offers a complete overview of a specific topic and provides practical advice for anyone interested in current aspects of laboratory validation.Available to download immediately. Prior to purchase … -
Audit and Control for Healthcare Manufacturers: A Systems-Based Approach (Hardcover)
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 … -
Biotechnology: From Idea to Market (Hardcover)
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 … -
Assuring Data Integrity for Life Sciences (Hardcover)
Book
This new book provides a truly global perspective on data integrity and the solutions available to address this serious issue. It includes two main sections: the regulatory and historic background of data integrity, and practical advice on how to prevent or rectify data integrity breaches.Each chapter …
Please sign in or become a member to purchase items from the PDA bookstore.