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Englisches GMP-Fachwissen | GMP Compliance Adviser Excerpts
Good Manufacturing Practice & Implementation
In unseren englischen E-Books finden Sie detaillierte Informationen und viele nützliche Beispieldokumente für die direkte Umsetzung.
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12 Cases from an Inspector's Practice Non-compliance can be expensive. Learn from others’...
117,00 € netto
125.19 - 7.00
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Planning and constructing cleanrooms is a complex task. Get to know how to successfully get...
117,00 € netto
125.19 - 7.00
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Handling packaging materials is a high-risk business because of the danger of mix-ups. Get to...
117,00 € netto
125.19 - 7.00
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A step-by-step guide to bring your drug manufacturing systems into compliance!
117,00 € netto
125.19 - 7.00
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Correctly Implementing GMP and GDP Requirements Current regulatory requirements and their...
117,00 € netto
125.19 - 7.00
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For auditors and manufacturers of drugs and APIs. More than 650 typical questions related to...
249,00 € netto
266.43 - 7.00
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The EU GMP Guide Annex 1 on sterile manufacturing of 2008 in comparison to the drafts of 2017...
99,00 € netto
105.93 - 7.00
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A helpful guide which facilitates the entry into the GMP world and teaches the necessary basics....
39,90 € netto
42.69 - 7.00
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How to Find and Fix Problems A FDAnews publication
147,50 € netto
157.82 - 7.00
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This e-book covers all aspects you have to consider when transferring! Including an example...
117,00 € netto
125.19 - 7.00
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What is the GMP-compliant approach and what do the single steps in the process flow look like?...
87,00 € netto
93.09 - 7.00
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Nowadays all regulatory authorities focus on data integrity and have their own data integrity...
345,00 € netto
369.15 - 7.00
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A qualification serves to prove that equipment is fit for its given purpose. So far, so good....
117,00 € netto
125.19 - 7.00
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This e-book shows how you can establish an effective CAPA system, which interfaces there are to...
87,00 € netto
93.09 - 7.00
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A Guide to Aseptic Processing
117,00 € netto
125.19 - 7.00
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Do your validation processes meet their specified requirements? This bilingual guide offers an...
59,00 € netto
63.13 - 7.00
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How to Meet the GMP Requirements of Annex 16 EU GMP Guide Batch release is complex and...
117,00 € netto
125.19 - 7.00
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How can occured failures be avoided in the future? Start to treat the root cause, not the...
87,00 € netto
93.09 - 7.00
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Does your cleaning validation meet the current requirements of Annex 15 to the EU GMP...
117,00 € netto
125.19 - 7.00
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Various different aspects must be considered in order to transfer documentation management,...
87,00 € netto
93.09 - 7.00
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The introduction of a LDMS has an extremely positive impact on the efficiency and quality of the...
87,00 € netto
93.09 - 7.00
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A step-by-step guide based on real-world examination experience. Discover how to document...
345,00 € netto
369.15 - 7.00
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This e-book lays out the basics of building a four-phase qualification plan - DQ, IQ, OQ and PQ...
345,00 € netto
369.15 - 7.00
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A comprehensive step-by-step guide, which covers all aspects of selecting and managing...
345,00 € netto
369.15 - 7.00