ECA - ICH Q7 Compliance for APIs Manufactured by Chemical Synthesis

Art-No.: A-440
Date: 04/06 November 2019

Price: EUR 380,-

The Conference folder includes the following topics:

No. Topic Summary Pages
6560APIC´s Ho to do guide and further APIC activities041
6566Cleaning Validation042
6571Preparing for GMP inspections041
6573Deviations and Failure Investigations038
7342Supply Chain Life Cycle: Reduced testing and supllier qualification042
7346Specific Training Sessions: - Defining API Starting Materials - Cleaning Validation - Practical implementation of ICH Q11 - How to identify and control CQAs in API synthesis0233
8649Major compliance issues at API manufacturers031
8651Internal Change Control Management040
9694Roles and Responsibilities of the Quality Unit - How to apply ICH Q10 in API manufacturing040
10001Equipment qualification and calibration039
12105Stability Testing of APIs032
12106Process Validation in API manufacturing 041
12356Engineering and Equipment Design036
14449ICH Q7 Q&A0116

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