. ICH Q7 WEEK .

Certificates / Certification

 

Certificate of Attendance

A Certificate of Attendance will be provided in any case for all participants for each course.

 

Additional Options:

- ECA certified QA Manager and Auditor for APIs

Pre-requisites:

  • First you have to take part in one of the ICH Q7 Compliance Courses (either "ICH Q7 Compliance for APIs manufactured by Chemical Synthesis“ or "ICH Q7 Compliance for APIs manufactured by Cell Culture/Fermentation“),
  • Thereafter you have to take part in the ICH Q7 Auditor Training Course.
     

If you have completed both the ICH Q7 Compliance Course and the ICH Q7 Auditor Training Course you will receive the ECA Certificate „QA Manager and Auditor for APIs

 

- APIC Auditor Certification

Pre-requisites:

  • You should have at least 5 years practical experience of GMP compliant manufacture in the pharmaceutical industry or API industry
  • You should already have conducted at least 10 external audits in the last 3 years. At least 1 audit per year should have been related to APIs, Intermediates or Starting Materials with ICH Q7 as standard
  • You have to take part in one of the ICH Q7 Compliance Courses (either "ICH Q7 Compliance for APIs manufactured by Chemical Synthesis“ or "ICH Q7 Compliance for APIs manufactured by Cell Culture/Fermentation“) before attending the ICH Q7 Auditor Training Course
  • You have to take part in the ICH Q7 Auditor Training Course after having attended one of the ICH Q7 Compliance Courses
  • You have to pass a written exam directly after the Auditor Training Course
  • You also have to pass an Internet-based exam appr. two weeks after the Auditor Training Course
     

Thereafter you will receive the APIC Auditor Certificate

→ Please return the filled in Questionnaire*!

(*The questionnaire is needed in order to verify the pre-requisite to apply for the APIC Auditor Certification and to plan the auditor workshop)