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FEATURED SESSION:

10:30AM - 11:15AM

APPLYING BEST PRACTICES FROM GMP
Examining Operational Efficiencies Achieved in the GMP Space and Effectively Translating Them to GCP

Patricia Santos-Serrao, RAC, Market Segment Director, Global Pharmaceutical, Blood and Biologics, MASTERCONTROL

  • Recognizing that many commonplace methodologies and practices in GMP achieve the same end results needed for GCP and can be repurposed and effectively implemented in the clinical space
  • Evaluating effective vendor auditing approaches and how they can be used in GCP
  • Incorporating methodologies for identifying deviations and assigning risk levels, and applying those methodologies to protocol review
  • Designing a training approach that focuses on high-risk areas
  • Walking through the CAPA methodology and applying similar processes to CAPAs in GCP operations

VIEW FULL AGENDA