INTERNAL STAKEHOLDER COLLABORATIONS: CREATE INTER-DEPARTMENTAL EFFICIENCIES TO OPTIMIZE INSPECTION PREPARATION

·     Refine processes that enable internal stakeholders to increase efficiency throughout the entire study, not just during the inspection preparation period

·     Understand nuances of inspection preparation deliverables according to agency expectations

·     Discuss the tools made available through technology to ascertain an accurate status of inspection readiness and facilitate inspection preparation

·     Train and support the education of functional departments to ensure internal synergy

·     Build credulity within your Inspection preparation team

Katherine Taylor, Director, GCP Inspection Management, MERCK

Christina DeLuca, GCP Inspection Lead, Associate Director, MERCK

 

RECOGNIZE TOOLS TO FOSTER A CULTURE OF COLLABORATION AND INHERENT INSPECTION READINESS

·     Discuss the core components of inspection readiness and how they can be built into everyday processes

·     Understand the importance of your people; how prepared are they to address challenges that come up during inspections?

·     Explain the necessity of interdepartmental collaboration to ensure internal preparedness

·     Communicate the commitment required for change management to be a company-wide initiative that mitigates inspection risk

Lydia Milne, Director, Quality Systems Inspection Program, ASTELLAS

 

 

BUILD EFFECTIVE TRAINING PROGRAMS FOR THE BIOPHARMA INDUSTRY

·     Define governance model for effective training program

·     Establish tools/LMS needed to manage the training program

·     Explore the competency model and risk-based delivery model

·     Examine various ways to measure training effectiveness

Sharon Brower, Director Training and Process and Continuous Improvements, BRISTOL-MYERS SQUIBB

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