ECA - GMP in API Development

Art-No.: A-431
Date: 04/05 June 2013

Price: EUR 380,-

The Conference folder includes the following topics:

No. Topic Summary Pages
6477Qualification in Development - System and Practical Aspects072
6478Cleaning - A big Challenge in Process Development038
6479Analytical data requirements044
6853Relevant Process Matters in Development040
8433Requirements for different development phases - The GMP Matrix035
8434Defining the API Starting Materials - What has to be considered042
8436Workshop: Identifying process parameters needed for process validation011
8437Workshop: Collecting data necessary to set up cleaning validation04
8438Workshop: Qualification in development01
9409Workshop: Collecting and compiling analytical data018
10740Process Validation - The new FDA Guidance042
11996Genotoxic Impurities in API supplies033

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