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25.Mar 2012 - Presented during the SC & HTL - Global Bioanalysis ...

to Computerised Systems. GMP. • USP <1058>. • GAMP5. • FDA 21CFR Part 11. • EMA Annex 11. • FDA Med Device. Guidance. Some of the Regs to Consider ...

PDF Book Title: A9 AIQ PRESENTATION FOR SAN ANTONIO CHAD BRISCOE
Link to file: www.globalbioanalysisconsortium.org 0




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26.CMT – Keeps your parameters under control - Siemens

Jun 17, 2009 ... GAMP 5. ▫ Life science Industry & CMT focus. ▫ CMT – 4 steps to comply ... FDA with 21 CFR 210, 211, EU with GMP Volume 4 & GAMP 5 ...

PDF Book Title: 4_CMT
Link to file: www.siemens.be 0




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27.GAMP 5 - ISPE

GAMP 5. Seite 7. Ein risikobasierter Ansatz für konforme GxP-computergestützte Systeme. Inhaltsverzeichnis. 1 Einleitung.

PDF Book Title: GERMAN-TABLE-OF-CONTENTS
Link to file: www.ispe.org 20




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28.good practices for computerised systems in regulated - PIC/S

PHARMACEUTICAL INSPECTION CONVENTION. PHARMACEUTICAL INSPECTION CO-OPERATION SCHEME. PI 011-3. 25 September 2007. PI 011- 3 ...

PDF Book Title: 27_PI-011-3-RECOMMENDATION-ON-COMPUTERISED-SYSTEMS
Link to file: www.picscheme.org 2




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29.Design Qualifizierung - Thermoguard

GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems; © ISPE 2008. Anhang: Thermoguard Produkt Information und Datenblätter ...

PDF Book Title: THERMOGUARD-DQ-041
Link to file: www.thermoguard.com 0




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30.GAMP 5 – Computersystem- Validierung in neuem Gewand Der ...

1. März 2009 ... Das Journal für GMP und Regulatory Affairs. Ausgabe 10, Januar 2009. Leitartikel. GAMP 5 – Computersystem-. Validierung in neuem Gewand ...

PDF Book Title: GMPJOURNAL_JAN09
Link to file: www.concept-heidelberg.de 0




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31.Computer Validation

.ispe.org/gamp5. This education course is recognised for the ECA GMP Certification Programme „Certified Computer Validation Manager“. Please find details at ...

PDF Book Title: ECA_COMP_VAL_2013
Link to file: www.gmp-compliance.org 1




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32.GT ENGINEERING VALIDATION Plan is better than fix

consulting services on cGMP and GAMP5 and implementation of Validation for ... This method is born founding on guideline GAMP5 (Good Automated ...

PDF Book Title: GT-VALIDATION
Link to file: www.gtengineering.eu 0




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