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The Bacterial Endotoxins Test: A Practical Guide
Book
This unique book is a collection of interdependent chapters that are part lab manual, part essay, part historical context, part consultant and part plain sage advice that provide a practical and compliant approach to the execution and use of BET. Full of sensible technological and compliance advice … -
Risk Assessment and Management for Healthcare Manufacturing: Practical Tips and Case Studies
Book
Avoidance of hazards and assessment of risk have long been part of the manufacture of pharmaceuticals and healthcare products. A high quality drug product must be free from contamination and reliably deliver the intended therapeutic dose as stated on the label and to achieve this manufactures must always … -
Recent Warning Letters Review for Preparation of a Non-Sterile Processing Inspection, Volume 2
Book
The focus of this book is to provide a way to prepare for an FDA inspection of a non-sterile facility by reviewing relevant Warning Letters recently issued. The number of Warning Letters issued by FDA has been rising in recent years. The FDA publishes Warning Letters in its Electronic Reading Room available … -
Rapid Sterility Testing
Book
Sale - 20% off! Original Price US$250 PDA Member, US$309 Nonmember, US$200 Government Sale prices are already displayed and will be reflected during checkoutThe current compendial sterility test methodology has been fully harmonized for Europe, Japan and the United States for many years. In spite of … -
Microbial Risk and Investigations
PDF
The Barr Decision (Barr, 1993) forever changed how pharmaceutical companies look at data that is out-of-specification (OOS). Following issue of this legal decision, many companies and regulators worked to determine how this decision affects microbiological test results.Microbial Risk and … -
Method Development and Validation for the Pharmaceutical Microbiologist
Book
The book primarily focuses on parenteral products and the excipients, but the methodology can transfer to other areas of microbiology as well. The book also provides advice on programs and special studies that might be performed in the pharmaceutical microbiology laboratory. The purpose of this book … -
Essential Microbiology for QP Candidates
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 … -
Environmental Monitoring: A Comprehensive Handbook, Volume 7
Book
Sale - 20% off! Original Price US$335 PDA Member, US$419 Nonmember, US$290 Government Sale prices are already displayed and will be reflected during checkoutThis is volume 7 of the Environmental Monitoring Handbook series. Each volume of this series discusses different aspects of environmental … -
Environmental Monitoring: A Comprehensive Handbook, Volume 5
Book
Sale - 20% off! Original Price US$335 PDA Member, US$419 Nonmember, US$290 Government Sale prices are already displayed and will be reflected during checkoutThis volume adds to the wealth of knowledge provided in the previous volumes by addressing several important issues not previously discussed in … -
Environmental Monitoring: A Comprehensive Handbook, Volume 4
Book
Sale - 20% off! Original Price US$335 PDA Member, US$419 Nonmember, US$290 Government Sale prices are already displayed and will be reflected during checkoutThe past decade has seen a global emphasis on environmental monitoring. Regulatory bodies worldwide have all established standards and guidelines … -
Environmental Monitoring: A Comprehensive Handbook, Volume 2
Book
Sale - 20% off! Original Price US$335 PDA Member, US$419 Nonmember, US$290 Government Sale prices are already displayed and will be reflected during checkoutEnvironmental monitoring programs are appropriate for manufacturing of sterile products and non-sterile products. The most stringent application … -
Effective Implementation of Audit Programs
Book
Effective Implementation of Audit Programs provides current perspectives on informal and formal audits.Written by Miguel Montalvo, who has more than 32 years of extensive experience in the areas of cGMP compliance, quality operations/systems and validation functions/responsibilities, this book applies … -
Contamination Control in Healthcare Product Manufacturing, Volume 4
Book
Edited by experts and written by global subject matter professionals, this vital addition to the Contamination Control series offers new chapters covering current, relevant information including:Regulatory changes relative to ISO 14644, Parts 1 and 2 Updates to ISO 11737-1 Risks of spores including preventive … -
Contamination Control in Healthcare Product Manufacturing, Volume 2
Book
Contamination Control in Healthcare Product Manufacturing, Volume 2, edited by Russell E. Madsen and Jeanne Moldenhauer, Volume 2 addresses some microbial control issues as well as other types of contamination. These valuable chapters will provide a great deal of information in your arsenal for contamination … -
Computerized Systems in the Modern Laboratory: A Practical Guide
Book
Sale - 20% off! Original Price US$265 PDA Member, US$329 Nonmember, US$210 Government Sale prices are already displayed and will be reflected during checkoutThe Bio/Pharmaceutical industry is at an interesting crossroads regarding the use of electronic technologies in laboratories. Laboratory management … -
Cleanroom Microbiology
Book
While there are books on cleanrooms available, these focus almost entirely on the physical and rarely address microbiological risks. Similarly, there are various books on microbiology (even a few about pharmaceutical microbiology), yet these books rarely mention cleanrooms, or, where they do, give controlled … -
Cleaning Validation: Practical Compliance Solutions for Pharmaceutical Manufacturing, Volume 3
Book
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 … -
Environmental Monitoring: A Comprehensive Handbook, Volume 8
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 … -
Cleaning Validation: Practical Compliance Solutions for Pharmaceutical Manufacturing, Volume 2
Book
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 … -
Biological Indicators for Sterilization Processes
Book
This book discusses the basic concepts necessary to the understanding of Biological Indicators and includes the history of biological validation and general principles, the kinetics of microbial inactivation and factors affecting resistance as well as guidance in understanding bacterial endospores …
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