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Validation on Dummy Environment
[
COMPUTER SYSTEM VALIDATION (CSV)
]
(1)
Open Vs Closed System
[
COMPUTER SYSTEM VALIDATION (CSV)
]
(7)
HEPA Certification Under Grade A
[
GOOD MANUFACTURING PRACTICE (cGMP)
]
(2)
What Do The cGMPs Mean By Separate Facilities?
[
GOOD MANUFACTURING PRACTICE (cGMP)
]
(19)
Eu fmd
[
GENERAL
]
(2)
FBD & RMG Capacity
[
TEMPLATES & PRESENTATIONS
]
(4)
WFI distribution system 121 C hot water sanitization
[
EQUIPMENT VALIDATION
]
(2)
Dish washing machin
[
EQUIPMENT VALIDATION
]
(6)
Autoclaving equipment using Steam/Air mixture
[
EQUIPMENT VALIDATION
]
(9)
Autoclave Qualification Acceptance Criteria
[
EQUIPMENT VALIDATION
]
(10)
Capacity calculation
[
EQUIPMENT VALIDATION
]
(1)
Vacuum pump Performance Qualification
[
EQUIPMENT VALIDATION
]
(3)
Vent Filter Temparature for Purified water storage Tank
[
PURIFIED WATER VALIDATION
]
(3)
Membrane 0.2 micron filter for compressed air
[
GOOD VALIDATION PRACTICE (cGVP)
]
(2)
Compressed Air for Pharma Plant
(
2
)
[
GOOD MANUFACTURING PRACTICE (cGMP)
]
(25)
Compressed air filter Integrity Testing
[
GOOD MANUFACTURING PRACTICE (cGMP)
]
(3)
Repetitive Deviation
[
DEVIATION AND DISCREPANCY HANDLING
]
(4)
Perforated SS 316 Plate Screen qualification
[
GOOD MANUFACTURING PRACTICE (cGMP)
]
(1)
What do you do when a critical deviation is performed?
[
DEVIATION AND DISCREPANCY HANDLING
]
(2)
Manufacturing Execution Systems (MES) & Validation
[
COMPUTER SYSTEM VALIDATION (CSV)
]
(6)
Steam Sterilization Lethality (Fo) Calculation
[
PQ (PERFORMANCE QUALIFICATION)
]
(5)
Stability study requirement-API
[
GOOD MANUFACTURING PRACTICE (cGMP)
]
(2)
Dynamic pass box- Functional Requirement
[
FDS (FUNCTIONAL DESIGN SPECIFICATION)
]
(10)
Difference between SAT and IQ/OQ
[
FAT AND SAT (FACTORY ACCEPTANCE TESTS AND SITE
]
(10)
DIP - Deviation investigation protocol: responsibilities
[
DEVIATION AND DISCREPANCY HANDLING
]
(18)
The Main Risks of Glove Damage Inside an Isolator
[
CLEANING VALIDATION
]
(1)
QA Review of QA documents
[
REGULATORY TRENDS AND QA
]
(2)
Autoclave Qualification: 2K Temperature Difference, & 1K Fluctuation in Empty Chamber Test
[
EQUIPMENT VALIDATION
]
(1)
Production process reworking
[
SUPPLIER AUDIT / QUALIFICATION
]
(1)
Lab euipment relocation validation master plan
[
EQUIPMENT VALIDATION
]
(1)
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