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

Art-No.: A-441
Date: 04/06 November 2019

Price: EUR 380,-

The Conference folder includes the following topics:

No. Topic Summary Pages
6574GMP Inspections at Biotech Companies048
6580Cellbanking - Master Cell Banks (MCB) and Working Cell Banks (WCB)036
6583Cleaning and cleaning validation in biotech manufacturing processes039
6587Supply Chain Life Cycle: Reduced testing and supplier qualification042
7351Deviations and Failure Investigations038
7352Preparing for GMP Inspections041
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 052
9695Instances of Virus Contamination in GMP Manufactured Products - What can we learn?032
11474APIC's How to do-Guide and further APIC activities041
12103Major compliance issues at API manufacturers031
12104Roles and Responsibilities of the Quality Unit - How to apply ICH Q10 in API manufacturing040
12357Stability testing for APIs032
14450ICH Q7 Q&A0116

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