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AGENDA
9.00
Clarifying the regulatory evolution on cleaning validation
-> Impact of the Annex 15 on cleaning validation and PIC/S update
-> FDA process validation guidance 2011
9.30 Traditional verse Life Cycle Approach to Cleaning Validation
Stage 1 - Cleaning Process Design
-> Cleaning Process Design o Critical cleaning parameters
-> Selecting cleaning agents o Cleaning methods
-> Laboratory testing design to support QbD approach o Process equipment design considerations
-> Water quality and utility concerns
-> Residual detection methods and sampling
-> Establishing acceptance criteria using health based limits
11.00 Coffee Break
11.15 Stage 2 - Cleaning Qualification
-> Documentation o Personal training
-> Process equipment and utility readiness o Analytical method readiness
-> Supplier approval 12
12.15 Lunch
13.15 Stage 3 - Continuous Monitoring of Cleaning Process
-> Quality management review of cleaning program
-> Periodic review of procedures and training
-> Process controls (capability, change control, dev iations)
-> Applying risk management tools
-> Continuous monitoring and PAT applications
-> Preventative maintenance program
15.00 Coffee Break
15.15 Visual inspection
Non-routine residues (biofilm, rouge, air-liquid interface rings...)
Stainless steel main tenance
16.15 Closure
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