ECA - ICH Q7 Compliance for APIs Manufactured by Chemical Synthesis

Art-No.: A-440
Date: 12/14 November 2018

Price: EUR 380,-

The Conference folder includes the following topics:

No. Topic Summary Pages
6560ICH Q7 - Regulatory Introduction035
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
10001Equipment qualification and calibration038
12105Stability Testing of APIs045
12106Process Validation in API manufacturing 040
12356Engineering and Equipment Design034
14449ICH Q7 Q&A0120

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