Preparing for FDA Pre-Approval Inspections

Introduction to the Food and Drug Administration Pre-New Drug Applications Approval Inspections o Developing a Strategic Approach to Preparing for a Successful Pre-NDA Approval Inspection o Food and Drug Administration International Pre-Approval Inspections o Stability Data and Pre-Approval Inspections o Consequences of Failing a Pre-Approval Inspection o Successful Management of a Pre-Approval Inspection o The Validation of Pharmaceutical Processes o Documentation Standards for Pre-Approval Inspections o Technology Transfer and Scale-up o Training of Personnel in the Pharmaceutical Industry o Compliance with Current Good Manufacturing Practices and Application Commitments