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.

12 Sessions
-Validation Life Cycle-Commissioning& Qualification
-Factory Zones& Facility Design
-Clean room Standard& HVAC Components
-Qualification of HVAC System
-Water Systems- Purified
-Qualification of water systems
-Equipment& Automated and Computerized Systems
-Thermal Mapping& Qualification of Compressed air systems
-Autoclave qualification& Pure Steam
-Tunnels and ovens Qualification
-Process Validation
-Cleaning Validation

1 Sessions

Attendance Type: Client Site
No. Of Sessions: According to Number of topics chosen from Below topics

Course Topics:
Risk Management approach and Tools
Material Handling Risk Assessment
Utilities risk assessment.
Materials and personelle flow risk
Environmental monitoring ( EM) risk assessment
Cross Contamination Prevention

Attendance Type: Client Site
Duration: 3 Session
Course Agenda:
- Session 1: Data integrity & Data governance awareness
- Session 2: Data integrity risk assessment
- Session 3: Implementation