Date: 10 November 2026
Delivery: Live Online
Prepare for GMP inspections with a practical, one-day live online training program focused on PIC/S GMP inspection readiness, risk-based gap analysis, Root Cause Analysis (RCA), CAPA, and evidence-based inspection responses.
Outlines:
• PIC/S & SFDA inspection framework
• Inspection lifecycle & inspector focus
• Risk-based GMP gap analysis
• ICH Q9(R1) risk prioritisation
• Root Cause Analysis, CAPA & effectiveness checks
• Evidence-based inspection responses
• 30/60/90-day readiness planning
Speaker Biography:
Dr. Merle Kock brings 25+ years of experience in Quality Assurance, Regulatory Compliance and Operations, with expertise in GMP inspections, Gap Assessments, Root Cause Analysis, CAPA and Quality Systems.
Her senior leadership experience includes roles as Head of Quality Assurance, Regulatory Liaison and Responsible Pharmacist, with extensive experience in regulatory inspections and quality improvement initiatives. She holds an MBA from the University of Pretoria and an MDP from GIBS.
