What are the GMP quality and compliance issues FDA leaders are most concerned about? Why is my site undergoing a surveillance inspection only months after a pre-approval inspection? And when should I expect to receive an EIR?

In conjunction with Quality Week, Redica Systems is releasing our latest report, “Insights on Quality from FDA Leaders,” which includes remarks about the current state of quality and compliance within the human drug GMP space. Redica Systems Senior GMP Quality Expert Jerry Chapman covered these remarks at the 2022 PDA/FDA Joint Regulatory Conference.

You can access the report, “Insights on Quality from FDA Leaders,” here.

What You Will Learn

• Pharma compliance issue trends
• The role of EIRs
• When FDA inspections are classified as OAI
• Timing of surveillance inspections following pre-approval inspections
• A case study in contamination failures that led to patient deaths
• The series of events that resulted a company coming under a consent decree

About the Expert

Jerry Chapman is a Senior GMP Quality Expert at Redica Systems. He brings 40 years’ experience in the pharma industry, including 31 years at Eli Lilly in technical and leadership positions in research and product development, manufacturing, plant quality, site quality, corporate quality, and quality systems.