Validation and Data Integrity in eClinical Platforms – A Concept Paper by the ISPE GAMP CoP

Clinical trials are conducted and managed as an independent project even if several trials investigate the same Investigational Medicinal Product (IMP). Each clinical trial is different as each address...
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ISPE’s CGMP Conference Continued with a Provocative Discussion on Process Validation

Jenn Walsh, Associate Director Manufacturing Technology, Bristol Myers Squibb moderated a night session on process validation. Dafni Bika, PhD, VP, Global Manufacturing and Supply, Bristol Myers Squibb, discussed the...
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