Microbial Identification: The Keys to a Successful Program (single user digital version)

Table of Contents:

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• Foreword by Dennis Guilfoyle
• Preface

1. Regulatory and Compendia Guidance on Microbial Identifications including Recent Regulatory Findings by Anthony M. Cundell
2. Primary Identifications Methods: Back to Basics by Marsha Stabler Hardiman
3. Microbial Identifications in the Quality Control Laboratory: A Multi-Component Approach by Scott Sutton
4. Challenges in Microbial Identifications by Jeanne Moldenhauer
5. Validation of An Automated Microbial Identification System by Amy McDaniel
6. Fungal Identification by Ziva Abraham
7. Identification of Adventitious Viral Contaminants of Cell Culture Processes by Martina Kopp and Houman Dehghani
8. Identification Mycoplasma Contamination: Concepts and Tools by Shayn E. Armstrong, Jill A. Mariano, Cynthia A. Martino, and John A. Ryan
9. Microbial Identifications in the Cosmetics Industry by Donald J. English
10. Microbial Identifications in Biopharmaceutical Manufacturing by Evelyn Der and Carole Genovesi
11. Microbial Identification — A Medical Device Perspective by Nina McAuliffe
12. Constructing A Microbial Identification Laboratory: Key Components and Element Benefits by Mary J. Griffin
13. Determination of Objectionable Organisms in Non-sterile Pharmaceutical Products — A Science-Based Risk Assessment Approach by Rhonda Ezell
14. Looking to the Future: Rapid and Automated Microbial Identification Technologies by Michael J. Miller
15. Implications of the Human Microbiome Project to Pharmaceutical Microbiology by Anthony M. Cundell
16. Microbial Knowledge Management by Frank Hallinan

About the Editors

Mary Griffin is currently principal of MG Quality Microbiology Consulting LLC, which she founded after working some twenty years at Wyeth BioPharma (Genetics Institute). Prior to joining Genetics Institute (GI) she served on the faculty at the University of Michigan and worked in a comparable role at University of Massachusetts where she developed and taught new techniques for microbial identifications. She subsequently applied that knowledge during the setting of quality standards for microbiology testing as part of the Quality Control (QC) organization at GI. In her leadership role she created a QC Microbial Science and Technology team dedicated to the qualification and validation of new technologies for the rapid detection and identification of microorganisms. In consulting, she continues to be at the forefront of emerging microbial technologies and applies her scientific knowledge, energy and passion to microbiology and quality standards. Other areas of expertise are risk assessment for objectionable organisms, laboratory design and contamination control. Mary holds a Masters degree in Microbiology and is certified as a Specialist Microbiologist with the American Society for Microbiology. She is a member of the Parenteral Drug Association, has taught a PDA TRI course, presented at numerous microbiology conferences and is published in the pharmaceutical industry.

Dona Reber has over 25 years of academic and industrial experience in microbiology, including contamination control of sterile and non sterile manufacturing, microbiology test development and managing and networking Quality Control microbiology laboratories. She is currently Senior Manager of Microbiology and Aseptic Support, Global Quality Operations for Pfizer involved in assessing aseptic processing facilities, micro-related risk assessments, troubleshooting and investigations, and is a Subject Matter Expert for training on micro related topics including aseptic behaviors. Dona holds Bachelors and Masters degrees in related sciences, and is certified as a Specialist Microbiologist (SM) in Pharmaceutical and Industrial Microbiology, Pharmaceutical/Medical Devices/Cosmetics with the American Society of Microbiology, is a member of the Parenteral Drug Association, and is recording secretary of the Pharmaceutical Micro Expert Discussion Group. She has a number of publications in the area of microbial identifications systems, microbiology lab training and microbiology risk assessments.