A Quality Risk Management Model Approach for Cell Therapy Manufacturing

Risk Analysis

Volumn 30, Issue 12, 2010, Pages 1857-1871

  Lopez, Fabio ^a   Bartolo, Chiara Di ^b,c   Piazza, Tommaso ^c   Passannanti, Antonino ^a   Gerlach, Jörg C ^d,e   Gridelli, Bruno ^c   Triolo, Fabio ^c  

^a UNIVERSITY OF PALERMO   (Italy)

^b Fondazione RiMED   (Italy)

^c MEDITERRANEAN INSTITUTE FOR TRANSPLANTATION AND ADVANCED SPECIALIZED THERAPIES ISMETT   (Italy)

^d MCGOWAN INSTITUTE FOR REGENERATIVE MEDICINE   (United States)

^e CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

Author keywords

Cell therapy; FMEA FMECA; Pareto analysis; Quality risk management; Regenerative medicine

Indexed keywords

CELL THERAPY; FMEA/FMECA; PARETO ANALYSIS; QUALITY RISKS; REGENERATIVE MEDICINE;

AUTOMATION; DECISION THEORY; FAILURE MODES; HIERARCHICAL SYSTEMS; PARETO PRINCIPLE; QUALITY ASSURANCE; QUALITY CONTROL; RELIABILITY ANALYSIS; RISK ASSESSMENT; RISK MANAGEMENT; RISK PERCEPTION;

RISK ANALYSIS;

CELL ORGANELLE; MEDICINE; REGENERATION; RISK ASSESSMENT;

ARTICLE; BIOLOGICAL THERAPY; HEALTH CARE QUALITY; NONBIOLOGICAL MODEL; ORGANIZATION AND MANAGEMENT; RISK MANAGEMENT; STANDARD;

MODELS, ORGANIZATIONAL; QUALITY ASSURANCE, HEALTH CARE; RISK MANAGEMENT; TISSUE THERAPY;

EID: 78649799232     PISSN: 02724332     EISSN: 15396924     Source Type: Journal    
DOI: 10.1111/j.1539-6924.2010.01465.x     Document Type: Article

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