INTERNAL STAKEHOLDER COLLABORATIONS: CREATE INTER-DEPARTMENTAL EFFICIENCIES TO
· 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
· 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