ECA - ICH Q7 Compliance for APIs Manufactured by Chemical Synthesis

Art-No.: A-440
Date: 13/15 March 2017

Price: EUR 380,-

The Conference folder includes the following topics:

No. Topic Summary Pages
6566Cleaning Validation049
6571Preparing for GMP inspections039
6573Deviations and Failure Investigations039
7339APIC's How to do-Guide and further APIC activities046
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 manufacturers033
8651Internal Change Control Management040
9694Roles and Responsibilities of the Quality Unit - How to apply ICH Q10 in API manufacturing036
9696How to use ICH Q9 and ICH Q11 in API development, manufacturing and Quality Assurance 043
10001Equipment qualification and calibration038
11473Storage, Transport and Distribution of APIs047
12105Stability Testing of APIs045
12106Process Validation in API manufacturing 040
12356Engineering and Equipment Design034

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