chapter 1 Regulatory Submissions / chapter 2 Compliance Requirements During the Drug Development Process / chapter 3 Validation: A New Perspective -- chapter 4 Validating Analytical Methods for Pharmaceutical Applications: A Comprehensive Approach -- chapter 5 The Stability Testing Program / chapter 6 Computer Validation: A Compliance Focus / chapter 7 Compliance Issues Associated with Cleaning in the Pharmaceutical Industry / chapter 8 The Batch Record: A Blueprint for Quality and Compliance / chapter 9 Change Management: A Far-Reaching, Comprehensive, and Integrated System -- chapter 10 The Vendor Qualification Program / chapter 11 Handling Laboratory and Manufacturing Deviations / chapter 12 The Internal Audit Program: A Quality Assessment / chapter 13 Preapproval Inspections: The Critical Compliance Path to Success / chapter 14 The Impact of Total Quality Performance on Compliance / chapter 15 International Compliance Issues and Trends / chapter 16 Strategic Planning for Compliance and Regulatory Defensiveness / chapter 17 Unique and Unprecedented Compliance Challenges in the Biologics Arena