29.10.2015

09:30 – 11:00

Risk Management Approaches

11:15 – 13:00

Purified water and water for injection systems:
 - requirements
 - production
 - storage and distribution
 - qualification
 - monitoring
 - inspection

13:00 – 14:00

Lunch break

14:00 – 16:00

Pure steam and compressed air systems
 - requirements
 - production
 - storage and distribution
 - qualification
 - monitoring
 - inspection

16:15 – 17:30

Practical tasks

30.10.2015

9:00 – 11:45

Cleanroom:
 - requirements,
 - AHU,
 - air purification,
 - design,
 - optimum air pressure differences between premises,
 - qualification,
 - requalification,
 - system monitoring,
 - inspection practices,
 - deviation management.

13:00 – 14:00

Lunch break

14:00 – 15:30

Cleanroom:
 - qualification & requalification,
 - system monitoring,
 - inspection practices,
 - deviation management.

15.40 – 16.20

Practical tasks

16.30 – 17:30

Tests and results