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Risk Management Basics
Protecting Profits and Product Safety in Medical Product Industries Through Risk-Based Decision-Making in Change Control, Deviation Investigations, and CAPA Programs
by Carol DeSain and Charmaine Sutton
Tamarack Associates, LLC - 2000
This book provides . . .
--> a risk management framework for product development, routine operations, and commercial distribution activities that is anchored in the product safety imperatives of the market and the patient.
--> an approach to the investigation of OOS results, deviations, complaints and study failures that protects the technical, trouble-shooting environment required to solve real problems, prevents potential problems, and preserves the business values and priorities of the organization.
-->a triage system for information monitoring programs and deviation investigations based on risk to product safety that conserves organizational resources.
-->examples of why things go wrong in high technology industries and how accidents-of-management can compromise corporate profit and product safety.
-->a new approach to organizational design that supports a product focused quality system and protects the productive core of the corporation from problems and inefficiencies.
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Table of Contents
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SECTION 1 - DETERMINING RISK FOR PRODUCTS AND PROCESSES DURING DEVELOPMENT
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Chapter 1: Product Risk Analysis
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Chapter 2: Process Hazard Analysis and Critical Control Point Identification
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SECTION 2 - RISK-BASED DECISION-MAKING PROCESSES IN COMMERCIAL OPERATIONS
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Chapter 3: Risk-Based Decision-Making for Monitoring Programs in Operations
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Chapter 4: Risk-Based Decision Making for Post-Market Feedback Monitoring
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Chapter 5: Risk-Based Decision-Making in Formal Investigations, Action ID and Authorization
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Chapter 6: Risk-Based Decision-Making in Action Implementation/Effectiveness Assessments
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SECTION 3 - MANAGING FOR SAFETY AND PROFIT
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Chapter 7: Why Things Go Wrong: Accident Theories
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Chapter 8: Managing Risk-Based, Decision-Making Groups to Protect Profits and Product Safety
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Chapter 9: Organizational Design: A New Approach
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Soft cover book - $85.00:
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Electronic copy -
$100.00 -
(PDF 768KB):
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Chapters:
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1- | Product Risk Analysis
, | | | 2- | Process Hazard Analysis and Critical Control Point Identification
- $15.00 - (PDF 194KB):
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3- | Risk-Based Decision-Making for Monitoring Programs in Operations
- $15.00 - (PDF 168KB):
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4- | Risk-Based Decision Making for Post-Market Feedback Monitoring
- $15.00 - (PDF 111KB):
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5- | Risk-Based Decision-Making in Formal Investigations, Action ID and Authorization
- $15.00 - (PDF 155KB):
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6- | Risk-Based Decision-Making in Action Implementation/Effectiveness Assessments
- $10.00 - (PDF 391KB):
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7- | Why Things Go Wrong: Accident Theories
- FREE - (PDF 112KB):
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8- | Managing Risk-Based, Decision-Making Groups to Protect Profits and Product Safety
- $15.00 - (PDF 140KB):
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9- | Organizational Design: A New Approach
- $15.00 - (PDF 141KB):
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