Attendance Type: Client Site
Duration: 2 Sessions
by Dr. Peter Nagi

Attendance Type: Client Site
Duration: 5 Sessions
By Dr. Peter Nagy

Course Topics: (7 Modules)
1. Quality Systems (2 Sessions)
2. Laboratory System (2 Sessions)
3. Infrastructure: Facilities, Utilities, Equipment (2 Sessions)
4. Materials management (1 Sessions)
5. Manufacturing Systems (1 Sessions)
6. Filling, Packaging, Labeling (1 Sessions)
7. Product Development (1 Sessions)

Number of Sessions:
10 Sessions

Attendance Type: Client Site
Duration: 7 Sessions
-Quality management system(QMS)
-Audits and self-inspections
-Risk management
-Data Integrity and Data Governance
-Change control and management
-Investigations and corrective and preventive action(CAPA)
-Product quality complaints vs. adverse event Reports
-Documents and records management
-Product trend requirements PQR
-Supplier and contractor quality management.