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Compliance: The Importance of Periodic Screenings to Ensure Good Inspection Health
Session Chair(s)
Grace M Crawford, MS
Global Head, Clinical Quality and Compliance
AstraZeneca, United States
The importance of periodic screenings (e.g. assessments, mock inspections) to ensure good inspection health. An interactive and colorful discussion of how being prepared by getting a thorough ‘check-up’ is the best way to be ready for an inspection.
Learning Objective : Demonstrate how periodic screenings are an important part of inspection readiness; Discuss where hidden challenges lurk and how mock inspections can bring these items to light; Identify appropriate remediation plans that are organizationally focused and not study specific.
Speaker(s)
Panelist
Barbara Maley
BLM Quality Consulting, LLC, United States
President/Managing Member
Panelist
Lauren Blomberg
Merck & Co., Inc., United States
GCP Inspection Lead, Quality and Continuous Improvement, GCTO
Panelist
Gina C Lucas
AstraZeneca Pharmaceuticals LP, United States
Director, Strategic Advice
Panelist
Matthew Krumrai
AbbVie, United States
Director, Clinical Quality Assurance