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Biyoteknolojik ilaçlar için
Biyoteknolojik ilaçlar için
analitik çözümler
17-19 İstanbul analitik çözümler
17-19
İstanbul Lütfi Kırdar
Nisan
İstanbul
İstanbul Lütfi Kırdar
Nisan
No° 203’deyiz...
No° 203’deyiz...
Sizi de bekliyoruz...
Sizi de bekliyoruz...
Part 11 Compliant
Part 11 Compliant
Network System
Network System
Software and other products provide the Validation Support
functionsrequired for FDA compliance. Validation Support
Software and other products provide the
functionsrequired for FDA compliance.
Data Processing Workstations and Systematic validation support for creating
network systemsfor meeting PIC/S GMP system operation andmanagement
Data Processing Workstations and
Systematic validation support for creating
and Part 11 demands procedures required for FDA compliance
network systemsfor meeting PIC/S GMP
system operation andmanagement
Support for creating
and Part 11 demandssystem control procedures required for FDA compliance
and management procedures
Support for creating system control
On-site/o -site user training Providing DQ templates
and management procedures
On-site/o -site user training Providing DQ templates
IQ/OQ computer validation
IQ/OQ computer validation
Accredited service support
Accredited service support
Q-TOF
MALDI Q-TOF
MS MALDI
MS
TOC GC
TOC GC
ICPMS
ICP ICPMS HPLC
HPLC
ICP
Balance
Balance UV
Shimadzu Total Solution UV
Shimadzu Total Solution Vendor Audit
for PIC/S GMP, FDA 21 CFR Part 11 Aggregates Vendor Audit
Shimadzu Total Solution
Sizer
for PIC/S GMP, FDA 21 CFR Part 11 Aggregates Vendor audits based on extensive
and Computerized
Shimadzu Total Solution
and Computerized
for PIC/S GMP, FDA 21 CFR Part 11 PPSQ Sizer Vendor audits based on extensive
and worldwide experience
Validation
for PIC/S GMP, FDA 21 CFR Part 11 Vendor Audit
and worldwide experience
Validation
Other and Computerized PPSQ ISO-9001 certi ed quality control system
vendor’s Vendor Audit
Supply of documentation, including Certi cates
ISO-9001 certi ed quality control system
Other
FTIR
instruments and Computerized FDA Latest Vendor audits based on extensive-
vendor’s Validation Supply of documentation, including Certi cates
instruments FTIR FDA Latest and worldwide experience
Vendor audits based on extensive-
Validation Information and worldwide experience
on FDA regulations and guidelines
Information
Timely issuing and supply of the ISO-9001 certi ed quality control system
on FDA regulations and guidelines
Supply of documentation, including
latest informationon FDA regulations ISO-9001 certi ed quality control system
Timely issuing and supply of the
and guidelines Certi catesof Compliance and
Supply of documentation, including
latest informationon FDA regulations
Certi catesof Compliance and
and guidelines Inspection Test Result Reports
Contracted FDA regulation consultants Inspection Test Result Reports
supply the latest information and provide
Contracted FDA regulation consultants
technical instruction
supply the latest information and provide
technical instruction
Shimadzu actively participates in FDA
seminarsalong with ISPE, PDA, and
Shimadzu actively participates in FDA
other organizations
seminarsalong with ISPE, PDA, and
other organizations

©ANT Teknik, 2019 All rights reserved.
©ANT Teknik, 2019 All rights reserved.