1. Introduce good manufacturing practice (GMP) and quality oversight key concepts, regulations, and guidance.
2. Provide a high-level overview of chemistry, manufacturing, and controls concepts and processes in the context of clinical-phase drug development expectations and applicable regulation and guidance.
3. Provide examples of CMC deficiencies and the potential ramifications that impact drug development and patient/research subject safety during the clinical development process.
Presented by: Susie Corl, MPH, CIP, CCRP, CHRC
Monday, May 24th, 12:00-1:00 EST
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SOCRA CEUs available: 1.0 CE credit hour for SOCRA CCRP Renewal. Only SOCRA members receive Certificates of Attendance.
Questions? Email Erica Denhoff, MPH, CCRP firstname.lastname@example.org – Boston chapter chair
SOCRA members and non-members welcome!