Risk management applications in pharmaceutical and biopharmaceutical manufacturing /
Mollah, A. Hamid,1962-
Long, Mike,1968-
Baseman, Harold,1956-
Includes bibliographical references and index.
Machine generated contents note: 1.Background and Introduction / A. Hamid Mollah -- 2.Risk Management Tools / Thomas Busmann -- 3.Risk Management: Regulatory Expectation, Risk Perception, and Organizational Integration / Mike Long -- 4.Statistical Topics and Analysis in Risk Assessment / Mike Long -- 5.Quality by Design / Bruce S. Davis -- 6.Process Development and Clinical Product Manufacturing / Karen S. Ginsbury -- 7.Points to Consider for Commissioning and Qualification of Manufacturing Facilities and Equipment / Michael Bogan -- 8.Process Lifecycle Validation / Scott Bozzone -- 9.Aseptic Processing: One / James E. Akers -- 10.Aseptic Processing: Two / Edward C. Tidswell -- 11.Pharmaceutical Product Manufacturing / Marlene Raschiatore -- 12.Biopharmaceutical Manufacturing / Thomas Genova -- 13.Risk-Based Change Control / Christophe Noualhac.
Pharmaceutical biotechnology.
Pharmaceutical biotechnology industry
Pharmaceutical technology.
Pharmaceutical industry
Risk management applications in pharmaceutical and biopharmaceutical products manufacturing