The Exl Proactive GCP Compliance Conference - Effective Risk-Based Approaches for Optimizing Clinical Quality and Achieving Inspection Readiness.
Featured Session - "Examining Operational Efficiencies Achieved in the GMP Space and Effectively Translating Them to GCP"
Presenter Patricia Santos-Serrao, RAC, market segment director, Global Pharmaceutical, Blood and Biologics, MasterControl, will cover:
1. 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
2. Evaluating effective vendor auditing approaches and how they can be used in GCP
3. Incorporating methodologies for identifying deviations and assigning risk levels and applying those methodologies to protocol review
4. Designing a training approach that focuses on high-risk areas
5. Walking through the CAPA methodology and applying similar processes to CAPAs in GCP operations