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PDA Technical Report No. 71 (TR 71) Emerging Methods for Virus Detection (single user digital version)
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Technical Report No. 71, Emerging Methods for Virus Detection describes and critically assesses methods currently used for the detection of potential adventitious viruses in biomedicinal products and their production processes. It also details new methods that have emerged as a result of technological … -
PDA Technical Report No. 70 (TR 70) Fundamentals of Cleaning and Disinfection Programs for Aseptic Manufacturing Facilities (single user digital version)
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PDA Technical Report No. 70, (TR 70) Fundamentals of Cleaning and Disinfection Programs for Aseptic Manufacturing Facilities identifies the systematic elements essential to assuring compliant cleaning and disinfection programs for aseptic and bioburden controlled manufacturing facilities and classified … -
Trend and Out-of-Trend Analysis for Pharmaceutical Quality and Manufacturing Using Minitab (single user digital version)
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A trend is a series of events or data collected, generally over time, that has an established and expected pattern. The trend can be observed or it can be based on theoretical models. Any departure from the trend is then an unexpected out-of-trend event. It is atypical and begs for investigation. Trend … -
Environmental Monitoring: A Comprehensive Handbook, Volumes 4, 5, 6 and 7 (single user digital version)
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Sale - 20% off! Original Price US$1,070 PDA Member, US$1,340 Nonmember, US$930 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 1, 2 and 3 (single user digital version)
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Sale - 20% off! Original Price US$800 PDA Member, US$1,000 Nonmember, US$700 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 4 (single user digital version)
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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 5 (single user digital version)
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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 6 (single user digital version)
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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 checkoutAn essential addition to this valuable series, Volume 6 offers current information about numerous subjects including E.M. computerized systems, … -
Environmental Monitoring: A Comprehensive Handbook, Volume 7 (single user digital version)
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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 … -
Microbial Risk and Investigations (single user digital version)
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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 … -
Computerized Systems in the Modern Laboratory: A Practical Guide (single user digital version)
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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 … -
PDA Technical Report No. 57-2, (TR 57-2) Analytical Method Development and Qualification for Biotechnology Products (single user digital version)
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This Technical Report provides practical, risk-based guidance for the development and qualification portions of the analytical method lifecycle for biotechnology products. Method development begins with defining the requirements for the analytical method and leads to, but does not necessarily finish … -
Cleaning and Cleaning Validation, Volumes 1 and 2 (single user digital version)
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Sale! Original Price US$535 PDA Member, US$670 Nonmember, US$465 Government Sale prices are already displayed and will be reflected during checkout"Cleaning and Cleaning Validation" is a series of volumes containing current knowledge and approaches to cleaning and cleaning validation of … -
Microbiology in Pharmaceutical Manufacturing, Second Edition, Revised and Expanded, Volumes 1 and 2 (single user digital version)
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Clearance Sale! Original Price US$375 PDA Member, US$465 Nonmember, US$250 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. Modeled on … -
Practical Aseptic Processing Fill and Finish, Volumes 1 and 2 (single user digital version)
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In honor of Jack Lysfjord who passed away on March 14, 2024, this bundle is 50% off until the end of the year. PDA remembers Jack Lysfjord as an expert in the field of Aseptic Processsing and he will be greatly missed. To learn more about Jack please click here … -
Thermal Validation in Moist Heat Sterilization (single user digital version)
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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 checkoutSince the advent of the Parenteral Drug Association's technical report on the validation of moist heat sterilization processes (PDA, 2007), it has … -
Validating Enterprise Systems: A Practical Guide (single user digital version)
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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 … -
Validation by Design: The Statistical Handbook for Pharmaceutical Process Validation (single user digital version)
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This book offers an overview of the statistical issues expressed and implied in the U.S. FDA`s Guidance for Industry Process Validation: General Principles and Practices, Draft, November 2008. The need for this book is illustrated by the many inquires the author receives about how to use and implement … -
Sterility Testing of Pharmaceutical Products (single user digital version)
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Sale - 20% off! Original Price US$240 PDA Member, US$299 Nonmember, US$210 Government Sale prices are already displayed and will be reflected during checkoutThe central argument of the book is that control of the process and environmental control are considerably more important guarantors of sterility … -
Risk Assessment and Risk Management in the Pharmaceutical Industry: Clear and Simple (single user digital version)
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Sale - 20% off! Original Price US$255 PDA Member, US$319 Nonmember, US$160 Government Sale prices are already displayed and will be reflected during checkoutRisk Assessment and Risk Management in the Pharmaceutical Industry: Clear and Simple, begins with history, definitions, how we think about risks …
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