Volume 2:Asceptic Manufacturing Facility DesignMark Caldwell, Bob Helt, Beth Holden, Francesca McBride, and Kevin SchreierPersonnel and their impact on Cleanroom OperationsJeanne MoldenhauerThe Fundamentals of an Environmental Control Program William H. MieleWater Systems for Pa…
Volume 3:CGMP Regulations of Parenteral DrugsTerry E. MunsonRisk Assessment and Mitigation in Aseptic ProcessingJames Agalloco and James AkersValidation of Drug Product Manufacturing Processes: NCEs and NBEs Karoline Bechtold-PetersVisual InspectionMaria Toler and Sandeep NemaAd…