Qualification Courses

APIC has developed qualification courses to provide an excellent knowledge of the requirements laid down in ICH Q7A.
To read more about the current programme at: www.ichq7a-week.org 

Choose between two 3-day GMP education courses according to your field of interest: ICH Q7A Compliance for APIs Manufactured by Chemical Synthesis or ICH Q7A Compliance for APIs Manufactured by Cell Culture/Fermentation.

These courses will explain the contents of ICH Q7A step by step and give practical advice on how to fulfil these requirements. For example:

• At which stage of production will GMP compliance be necessary and how can it be verified?
• How to comply with GMP hot topics like process validation, reprocessing/reworking, equipment qualification, failure investigation, etc.?
• What are necessary features; what is nice to have? Which procedures are available for regulatory submission of information on APIs and on post approval changes to their manufacture?

The number of participants is strictly limited.

With this programme, you have the unique opportunity to combine your ICH Q7A Training Course on Chemical Synthesis or Cell Culture/ Fermentation with an ICH Q7A Auditor Training Course. This training course will inform you about the techniques and skills to be used during an audit.

About the "ICH Q7A Auditor Certification Scheme"

The "ICH Q7A Auditor Certification Scheme" offers the opportunity to achieve an outstanding qualification. This certificate will be issued by APIC when the following 4 prerequisites are fulfilled:

1. Participation in

• ICH Q7A and FDA Compliance for Active Pharmaceutical Ingredients Manufactured by Chemical Synthesis
  or

• ICH Q7A and FDA Compliance for APIs Manufactured by Cell Culture/ Fermentation

2. Participation in the ICH Q7A Auditor Training Course
   Please visit www.ichq7a-week.org or contact CONCEPT HEIDELBERG at info@concept-heidelberg.de

3. Professional experience as documented in the questionnaire (this questionnaire has to be filled in together with the registration form of the ICH Q7A Auditor Course)

4. Contract between the participant and the API Compliance Institute that defines the responsibilities of an APIC Certified Auditor