Recent Warning Letters Review for Preparation of a Non-Sterile Processing Inspection, Volume 2 - Hardcover
Inhaltsangabe
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 on its website. 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 non-sterile 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.
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Über die Autorinnen und Autoren
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 an Aseptic Processing Inspection; Steam Sterilization: A Practitioner's Guide; Laboratory Validation: A Practitioner's Guide; and the Editor of Environmental Monitoring Volumes 1, 2 and 3 and Systems Based Inspections for Pharmaceutical Manufacturers among numerous other recent publications.
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 an Aseptic Processing Inspection; Steam Sterilization: A Practitioner's Guide; Laboratory Validation: A Practitioner`s Guide; and the Editor of Environmental Monitoring Volumes 1, 2 and 3 and Systems Based Inspections for Pharmaceutical Manufacturers among numerous other recent publications.
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Recent Warning Letters Review for Preparation of a Non-Sterile Processing Inspection, Volume 2
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