Preparing for FDA Pre-Approval Inspections

<p>This <strong><em>Second Edition</em></strong> is an essential guide to preparing for FDA pre-approval inspections—taking into account current trends in FDA expectations and inspection activities such as the GMPs of the 21st Century quality systems-based approach to inspections risk-based inspections quality by design process analytical technology design space etc. The goal of this book is to help organizations gain rapid regulatory approval.</p><p><strong><em>Pharmaceutical Pre-Approval Inspections: A Guide to Regulatory Success Second Edition</em></strong>:</p><ul> <li>chronicles the major shifts in inspection activity as evidenced by a systems-based approach to inspections</li> <li>demonstrates what each area of pharmaceutical development from research and development to training is expected to provide to inspectors</li> <li>focuses on traditional development and submission activities but also discusses cases where the transfer is from a domestic site to an international facility</li> </ul>