Essential Microbiology for QP Candidates (Hardcover)
- Published
- Sep 2007
- ISBN
- 1-933722-18-5
- Pages
- 314
- PDA Item Number
- 17265
- Format
- Book
- Member Price
- $175.00
- Nonmember Price
- $220.00
- Government Price
- $130.00
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This book has been prepared to address the requirements which are stated in the Guide to the Knowledge and Practical Experience Required by Qualified Persons in the Pharmaceutical Industry (the "Study Guide") in relation to pharmaceutical microbiology.
This reference guide will help QP candidates prepare for the assessment board, as well as refresh QPs who are faced with actual or potential microbiology problems. This guide additionally serves as a useful starting point for QPs who may wish to explore pharmaceutical microbiology in greater depth than simply what is required by the Study Guide.
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Table of Contents
Table of Contents:
Click here to download >>>Detailed Table of Contents
Introduction (Click here to
download >>>Introduction )
1. Essential Background
Microbiology
2. Contamination Control
3. Microbiological Quality
Control
4. Water Microbiology
5. Manufacture of Sterile Products
6.
Sterilisation and Depyrogenation
7. Disinfectants
8. Endotoxins and the
LAL Test
9. Simulation (Media Fills)
10. Preservative Efficacy
11.
Modern Methods
12. Microbiological Assay
Appendix by Bruce
Vernon
About the Authors
Index
About the Authors
About the Author
Dr. Nigel Halls is Executive Director for Science and Technology and a founding partner of IAGT (International Academy of GMP Training) Ltd. - one of Europe’s fastest growing training and consultancy organisations. He has degrees in Microbiology from the Universities of Bradford and Bath (UK) and has worked in the pharmaceutical and sterile medical devices industry for many years. His principle professional interests are sterile manufacture, manufacture of aqueous pharmaceutical products, and design, control and monitoring of pharmaceutical water systems.
Dr. Halls` extensive publications include Achieving Sterility (1994) and Microbiological Contamination Control in Pharmaceutical Clean Rooms (2004). He recently scripted multi-media pharmaceutical training programmes for MVI International. He serves as member of the Fellowship and Membership Committee of the Institute of Biology (UK) and is an active member of PDA. At the time of writing he is serving as a member of the Special Task Group charged with revising PDA Technical Report 1, Validation of Moist Heat Sterilization Processes: Cycle Design, Development, Qualification and Ongoing Control.
Bruce Vernon is a versatile quality systems, regulatory and product development consultant with very wide ranging experience. An immunologist by training and chartered biologist. Bruce gained his Master`s degree in 1995 while working with the UK Blood Transfusion Service (BTS) after his initial training in Medical Laboratories and some time abroad working as technical advisor to the Nepal Red Cross Blood Transfusion Service.
Bruce has 30 years experience within GLP and GMP licensed Facilities (FDA and MHRA), the last 10 years at senior management level within the biotech/pharma sector.