Pharmaceutical Industry Training
Join our professional pharmaceutical industry training focused on FDA, QA, CSV, and regulatory compliance. Gain practical insights into enforcement trends, data integrity, and system validation. $299 per day, per person. Limited seating available.
Speaker: Myriam Sosa, MSPH
President – The Gintegra Group (TGG)
8:00 AM – 12:00 PM
Latest Trends in FDA Enforcement Actions & Significant Updates
12:00 PM – 1:00 PM
Lunch Break
1:00 PM – 5:00 PM
Pharma Deviations & Investigation Fundamentals
Speaker: José E. Matos, MS CpE, MS CIS
Senior Consultant / IT Leader – The Gintegra Group (TGG)
8:00 AM – 12:00 PM
• CSV fundamentals (GxP systems)
• FDA & data integrity expectations
• Computer Systems Validation (CSV) & Data Integrity (DI)
• Risk-based validation approach
12:00 PM – 1:00 PM
Lunch Break
1:00 PM – 5:00 PM
What Do You Need to Know?
QA / QC Departments, Compliance Auditor, Regulatory Affairs, CSV & IT Validation Teams-Manufacturing & Engineering. Information Technology (IT), Automation Engineering, Project Managers, Equipment and Process Validation professionals. Computer Science and/or Computer Engineering students.
