Course Topics:
Cleaning Validation Design and considerations
Workshop 1 : Creation of protocols for solid line
Workshop 2 : Creation of protocols for liquid line.
Workshop 3 : Creation of protocols for vial/ampoule line.

Number of Sessions:
4 Sessions

Course Topics
Day 1: Operation

Receiving, Dispatch, Maintenance , Physical count, Location system, identification , Infrastructure , Recall, Falsified , Return

Day 2: Operation

Cleaning, Trucks monitoring and maintenance, Fire fighting, Temperature monitoring , Power off recovery, FEFO, Printing process, Temperature monitoring , Power off recovery, FEFO, Printing process, Invoicing

Day 3: Quality Management System

SMF , JD, Organization chart, Documented information, Risk management , Deviation, Complaint

Day 4: Quality Management System

Physical security, Pest control, Hazard control, Training, Management review, CAPA

Day 5: Quality Management System

Self inspection , Calibration , Contracts, Validation warehouse, cold room, printing, truck.

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