FORUM INSTITUT COURSE | Integrated product development

ASPHALION expert André Mota, together with other two excellent lecturers will share their in-depth knowledge since to make the most of ICH Q12 opportunities as a lifecycle manager, you have to be aware of the relation between ICH guidelines Q8 to Q12 and how to properly integrate them.

ASPHALION expert André Mota, together with other two excellent lecturers will share their in-depth knowledge since to make the most of ICH Q12 opportunities as a lifecycle manager, you have to be aware of the relation between ICH guidelines Q8 to Q12 and how to properly integrate them.
November 2, 2021
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📆 11 November, 2021

💻 Online course

ASPHALION expert André Mota, together with other two excellent lecturers will share their in-depth knowledge since to make the most of ICH Q12 opportunities as a lifecycle manager, you have to be aware of the relation between ICH guidelines Q8 to Q12 and how to properly integrate them.

The online training course will cover the following topics:

  • From QbD (ICH Q8) to designed lifecycle management (ICH Q12): How to make the most of ICH Q12 opportunities
  • Special considerations and challenges for biologics
  • ICH Q8 and ICH Q11: Mastering QbD concepts
  • ICH Q9 and Q10: “Tools” to implement QbD
  • ICH Q12: Interpretation and implementation

AIMS AND OBJECTIVES:

It’s absolutely critical that you understand the need of mastering the different Quality by Design (QbD) options and that you realise their implications.

Our experts will go through each guideline with focus on ICH Q8 (drug product) and ICH Q11 (drug substance). They will point out the specific challenges with interpretation and implementation and the relation between all guidelines.

In the end you will be trained in a more conceptional way on the desired outcome of mastering QbD to make the most of ICH Q12.

 

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