Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing

<p>Preface vii</p>
<p>Contributors xi</p>
<p>About the Authors xiii</p>
<p>1 Background and Introduction 1<br /> Harold S. Baseman and A. Hamid Mollah</p>
<p>2 Risk Management Tools 17<br />Mark Walker and Thomas Busmann</p>
<p>3 Risk Management: Regulatory Expectation, Risk Perception, and Organizational Integration 49<br /> Mike Long</p>
<p>4 Statistical Topics and Analysis in Risk Assessment 75<br /> Mike Long</p>
<p>5 Quality by Design 89<br /> Bruce S. Davis</p>
<p>6 Process Development and Clinical Product Manufacturing 101<br /> Karen S. Ginsbury</p>
<p>7 Points to Consider for Commissioning and Qualification of Manufacturing Facilities and Equipment 129<br /> Harold S. Baseman and Michael Bogan</p>
<p>8 Process Lifecycle Validation 179<br /> A. Hamid Mollah and Scott Bozzone</p>
<p>9 Aseptic Processing: One 227<br /> James P. Agalloco and James E. Akers</p>
<p>10 Aseptic Processing: Two 243<br /> Edward C. Tidswell</p>
<p>11 Pharmaceutical Product Manufacturing 275<br /> Marlene Raschiatore</p>
<p>12 Biopharmaceutical Manufacturing 325<br /> Ruhi Ahmed and Thomas Genova</p>
<p>13 Risk–Based Change Control 367<br /> William Harclerode, Bob Moser, Jorge A. Ferreira, and Christophe Noualhac</p>
<p>Index 387</p>