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Risk Management Library Volume 4: Practical Approaches To Risk Assessment and Management Problem Solving: Tips and Case Studies
Risk Management Library Volume 4: Practical Approaches To Risk Assessment and Management Problem Solving: Tips and Case Studies
Tim Sandle
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Risk Management Library, Volume 4
Tim Sandle
PDA
Bethesda, MD, USA
DHI Publishing, LLC
River Grove, IL, USA
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10 9 8 7 6 5 4 3 2 1
ISBN: 978-1-942911-21-0
Copyright © 2018 Tim Sandle
All rights reserved.
This book is printed on sustainable resource paper approved by the Forest Stewardship
Council. The printer, Gasch Printing, is a member of the Green Press Initiative and all paper
used is from SFI (Sustainable Forest Initiative) certified mills.
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CONTENTS
iii
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iv Risk Assessment and Management Problem Solving
3 CASE STUDIES:
ASEPTIC TRANSFER RISK ASSESSMENT 43
Introduction 43
Approaches to Risk Assessment 44
Applications to Cleanroom Environments and
Pharmaceutical Processes 46
HACCP 46
The Case Study 49
Deconstructing the Process 50
Risk Assessment 55
Conclusion 55
References 56
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Contents v
Risk 2: Obsolescence 83
Risk 3: Insufficient Time Allocated to Upgrade 84
Risk 4: Bringing New Products On-Line 85
Risk 5: Failing to Embrace New Innovations 85
Risk 6: Microbiological Contamination 86
Risk 7: Regulatory Concerns 88
Risk 8: Knowledge Base 89
Risk 9: Validation Status 89
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