Inspection Readiness with Donna Dorozinsky

About this episode

Kunal Sampat discusses inspection readiness with Donna Dorozinsky, an expert in clinical research operations.

To discuss what inspection readiness entails, I invited Donna Dorozinsky, Founder & CEO of Just in Time GCP to the show. Donna is a business consultant who has over 30 years of experience in study operations that includes clinical operations, safety, data management, biostatistics, clinical supply management, and TMF management. Her vast experiences dealing with small to large pharmaceutical companies, academic centers, regulatory agencies, clinical research organizations, and investigator sites provides her with the knowledge to assist research organizations in all areas of clinical compliance. Donna has presented training programs in topics of GCP compliance, Quality Management Systems, Inspection Readiness, and Trial Master File (TMF) Management. She is the Lead Editor in the newest edition of Good Clinical Practice: A Question and Answer Guide 2024/2025, is a member of the TMF Reference Model Steering Committee, and was recently named an Ernst & Young Entrepreneur of the Year. Donna earned a Bachelor of Science in Nursing from Gwynedd Mercy University where she is currently serving as a member of the Board of Trustees and a Master of Science in Nursing from Widener…

People in this episode

Guest: Donna Dorozinsky

Topics covered

• inspection readiness
• clinical operations
• GCP compliance
• Quality Management Systems
• Trial Master File management

Keywords

• clinical research
• compliance
• pharmaceutical companies
• regulatory agencies

Mentioned in this episode

Products: Good Clinical Practice: A Question and Answer Guide 2024/2025

Books & works: a Bachelor of Science in Nursing

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