FDA, Good Manufacturing Practices GMP, quality system, QSR, ISO 13485, regulatory consultants, manufacturing development device, drug, diagnostic, combination medical products, 510k, PMA, IDE
book, risk, analysis, assessment, process, product, critical control points, development, device, drug, pharmaceutical, design control, business, HACCP, ISO 14971, investigation 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.

Table of Contents
SECTION 1 - DETERMINING RISK FOR PRODUCTS AND PROCESSES DURING DEVELOPMENT
Chapter 1: Product Risk Analysis
Chapter 2: Process Hazard Analysis and Critical Control Point Identification
SECTION 2 - RISK-BASED DECISION-MAKING PROCESSES IN COMMERCIAL OPERATIONS
Chapter 3: Risk-Based Decision-Making for Monitoring Programs in Operations
Chapter 4: Risk-Based Decision Making for Post-Market Feedback Monitoring
Chapter 5: Risk-Based Decision-Making in Formal Investigations, Action ID and Authorization
Chapter 6: Risk-Based Decision-Making in Action Implementation/Effectiveness Assessments
SECTION 3 - MANAGING FOR SAFETY AND PROFIT
Chapter 7: Why Things Go Wrong: Accident Theories
Chapter 8: Managing Risk-Based, Decision-Making Groups to Protect Profits and Product Safety
Chapter 9: Organizational Design: A New Approach

Soft cover book - $85.00: To Order
Electronic copy - $100.00 - (PDF 768KB): Contact us to Order

Back to Books Home Downloads