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

Art-No.: A-441
Date: 13/15 March 2017

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
12357How to use ICH Q9 and ICH Q11 in API development, manufacturing and Quality Assurance043
12781Equipment qualification and calibration038
12782Storage, Transport and Distribution of APIs047

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