ECA - ICH Q7 Compliance for APIs Manufactured by Cell Culture/Fermentation

Art-No.: A-441
Date: 11/13 June 2018

Price: EUR 380,-

The Conference folder includes the following topics:

No. Topic Summary Pages
6580Cellbanking - Master Cell Banks (MCB) and Working Cell Banks (WCB)050
6583Cleaning and cleaning validation in biotech manufacturing processes040
6587Supply Chain Life Cycle: Reduced testing and supplier qualification042
7351Deviations and Failure Investigations039
7352Preparing for GMP Inspections039
8673Internal Change Control Management040
8674Specific Training Sessions: - Process validation for biotech manufacturing processes - Cleaning validation - Principles of risk assessment from Cell Banks to viral safety 00
9695Instances of Virus Contamination in GMP Manufactured Products - What can we learn?035
11474APIC's How to do-Guide and further APIC activities046
12102ICH Q7 - Regulatory Introduction035
12103Major compliance issues at API manufacturers033
12104Roles and Responsibilities of the Quality Unit - How to apply ICH Q10 in API manufacturing036
12357Stability testing for APIs040
14450ICH Q7 Q&A0120

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