Parenteral Drug Assn.

Edited by Michael J. Miller, PhD, Volume I of the Encyclopedia of Rapid Microbiological Methods is now available from the Parenteral Drug Assn. Volumes II and III are scheduled for release in December 2005.

This three-volume encyclopedia focuses on regulatory and compendial initiatives currently in place that will help pharmaceutical microbiologists begin the journey of implementing RMM in their facilities, and describes the many rapid methods currently available. The hardcover book is available for $275 to PDA members, $339 for non-members.

Table of Contents:

1. Overview of microbiological methods and opportunities for industry
  • Early History of Microbiology and Microbiological Methods by Robert F. Guardino

  • Risk-Based Approach to Pharmaceutical Microbiology by Anthony Cundell

  • The Importance of Emerging Rapid Methods Technology to Regulators and Industry by Michael Korczynski

  • Obstacles and Opportunities to the Introduction of Pharmaceutical Rapid Microbioogical Methods by Paul Newby

  • Fact Versus Fiction: Rapid Methods in the Manufacturing Environment by Christopher Bierman

  • Opportunities for the Pharmaceutical Industry by Scott Sutton

  • Applications for rapid methods in Homeland Defense by George A. Robertson

  • Rapid and Automated Methods for Food Microbiology by Daniel Fung
2. Regulatory and Compendial Perspectives
  • Regulatory initiatives, Process Analytical Technology and opportunities for rapid methods by Michael J. Miller

  • Comparability Protocols by Jeanne Moldenhauer

  • FDA Perspectives on 21 CFR Part 11 Requirements by Brenda Uratani and George Smith

  • European Perspectives on Rapid Microbiological Methods and Risk Assessment by Klaus Haberer

  • Current USP Perspectives on Alternative Microbiological Methods: USP Chapter <1223> by Radhakrishna Tirumalai

  • PDA Technical Report No. 33: Evaluation, Validation and Implementation of New Microbiological Testing Methods by Jeanne Moldenhauer
3. Validation Strategies
  • Validation of Rapid Microbiological Methods by Jeanne Moldenhauer

  • 21 CFR Part 11 for Laboratory Systems: A Case Study by Arjun Castelino

  • End-user Expectations for Vendors of Rapid Microbiological Methods by Casey Costello


About the Editor

Michael J. Miller, PhD is a Senior Research Fellow for Eli Lilly and Co., and is responsible for providing technical leadership in microbiology and sterility assurance within Manufacturing, Quality, Engineering, and Product Development. He is also accountable for driving Lilly’s corporate initiatives for Process Analytical Technology (PAT), barrier isolation technology and rapid microbiological methods. Dr. Miller has authored over 60 technical publications and presentations in the areas of rapid microbiological methods, PAT, ophthalmics, disinfection and sterilization, and has served as Chairperson for numerous rapid microbiological methods technical conferences in the United States and Europe.

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