|
 The
requirements to the quality assurance of active pharmaceutical
ingredients have increased enormously, among others, due to the
establishment of the ICH Q7 "Good Manufacturing Practice Guide for
Active Pharmaceutical Ingredients". Therefore, highly qualified experts
are necessary to put these requirements correctly into practice. The ECA
Certified API Production Manager learns the rudiments in one of the
3-day intensive courses and can deepen this know-how according to his or
her focus by means of two further seminars.
For questions relative to the ECA Certified API Production Manager, please
contact heimes@gmp-compliance.org.
To obtain the additional certificate, the applicant must attend three out
of the following courses / conferences. After attending the third
course, the applicant obtains the additional certificate "ECA Certified
API Production Manager".
- Chapter 19 ICH Q7: APIs for use in clinical trials
- ICH Q7 Compliance for APIs Manufactured by Chemical Synthesis
- ICH Q7 Compliance for APIs Manufactured by Cell Culture/Fermentation
- ICH Q7 Auditor Training Course
- 13th APIC/CEFIC European Conference on Active Pharmaceutical
Ingredients, GMP Part
To get to the calendar with all courses and conferences currently
offered for this programme - including a link to the contents and a
booking form - please go here. |
