About Amitkumar Naik:
I have been dealing with pharmaceutical CSV system , CQV engineer for more than 10+ years and faced all regulatory audits.
Worked extensively Qualification of new and legacy system updation to comply for CSV as per GAMP5
Following are the details of documentation carried out for CSV system
1) Change control
2) Assessment of required documentation for CSv system
3) URS
4) FDS
5) Traceability matrix
6) Design qualification
7) FAT acceptance test
8) IQ/OQ/PQ
9) SOP preparation
10) Validation for CSV system
11) Periodic evaluation
12) Equipment history card
13) System description
14) Handover
15) Periodic review
Experience
15+ years experience in pharmaceutical CSV / CQV specialist.
Education
Mechanical Engineering
Professionals in the same Pharmaceutical / Bio-tech sector as Amitkumar Naik
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