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Recent Warning Letters Review for Preparation of an Aseptic Processing Inspection, Volume 1 (single user digital version)

By Jeanne Moldenhauer

PDF Single user
Gov. Price: $140.00Member Price: $196.00Nonmember Price: $245.00
  • Description
  • Table of Contents
  • Author's Bio

The focus of this book is to provide a way to prepare for a FDA inspection of an aseptic facility by reviewing Warning Letters recently issued to pharmaceutical companies. 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 on its website (www.fda.gov). The problem is that it takes time to download and review the documents and look at them cohesively for their impact on your operation. This book has taken these observations and segregated them according to the applicable GMP requirements, making them easier to look at in a systematic fashion.

Based upon lengthy industry experience, Jeanne Moldenhauer has done the work for you by reviewing all relevant recent Warning Letters for aseptic processing topics and has identified areas of focus and interest for investigators, some of the types of issues deemed important by the investigator, and potential issues that may be applicable at an aseptic processing site.

This invaluable guide is a must read for all personnel involved in any way with the pharmaceutical aseptic processing inspection process.

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Book wrote in April 2010

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Format: PDF (1 file 8.47 MB)

Table of Contents:

Click here to download>>>Detailed Table of Contents

1. Introduction
2. Why Can FDA Inspect My Plant?
3. FDA`s Approach to Inspections
4. A Review of Recent Warning Letters: Aseptic Processing

About the Author

Jeanne Moldenhauer,
Excellent Pharma Consulting, has nearly 30 years of experience in the pharmaceutical industry. She chairs the PDA Environmental Monitoring/Microbiology Interest Group, serves on the PDA Scientific Advisory Board, founded the Rapid Microbiology User`s Group TM, and is a member of ASQ and RAPS. She is the author of Recent Warning Letters Review for Preparation of a Non-Sterile Processing Inspection, Volume 2; Recent Warning Letters Review for Preparation of an Aseptic Processing Inspection and the Editor of Steam Sterilization: A Practitioner`s Guide; Laboratory Validation: A Practitioner`s Guide; Systems Based Inspections for Pharmaceutical Manufacturers and Thermal Validation in Moist Heat Sterilization among numerous other recent publications. She is the winner of the 2010 and 2005 PDA/DHI Distinguished Editor/Author Award.

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