Table of Contents
Productivity and the Economics of Regulatory Compliance in Pharmaceutical Production
Declaring a Few Biases ....
Improving the Economics of Compliance
Our Business Environment - Tough & Getting Tougher
Shareholder Returns - Falling
R&D Productivity - Falling
Window of Exclusivity - Decreasing
Pharma Manufacturing - Unmet Performance Expectations
Our Findings - Problems Start in Development
EXAMPLE: Parenteral Emulsion
EXAMPLE: SVP Emulsion
What is the Potential for Improvement?
EXAMPLE: Value Added -vs- Non Value Added Process Time
EXAMPLE: See It to Fix It - Value-Added Time Only 3 Days!
Measurement Shows Potential for Improvement
EXAMPLE: Traditional MRP II Measurement - For Accountants.
EXAMPLE: Measuring for Productivity - Reveals Potential
EXAMPLE: Sigma - Getting it Right First Time.
Measure Spread & Variability
Calculating The Purely Business Benefits
A Thought Experiment - 5 Sigma Pharmaceutical Production
Benefits - Increased Effectiveness of Compliance Infrastructure
How this is a Win-Win