2016 AM: A - Auditing Biologics for GLP Compliance

2016 AM: A - Auditing Biologics for GLP Compliance
A • 70 minutes



Auditing Biologics for GLP Compliance



Deborah Parker, Bristol-Myers Squibb

Kami Wagner, Bristol-Myers Squibb

Lucy Podbielski, WIL Research



As the interests of global pharmaceutical companies turn towards biologic molecules to answer unmet medical need, the knowledge and experience base for auditors can be challenged by the new technologies being utilized in the analytical and bioanalytical space. Three seasoned GLP auditors with scientific backgrounds will walk you through the nuances of auditing biologics for GLP compliance, including: test article characterization analysis, dose formulation analysis, validation of TK/PK assays, auditing the data in LIMS, and important aspects for Immunogenicity and Biomarker assays.
Discounted member price: 20.00
30.00
You could save: 33%

Similar products

No products found