Mastering ICH Quality Guidelines: From Development to Lifecycle Management - Quality by Design and strategies for a successful ICH Q12 implementation

- 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 implementationTo make the most of ICH Q12 opportunities, you have to be aware of the relation between ICH guidelines Q8 to Q12 and how to properly integrate them. Our experts willgo through each guideline and train you on the desired outcome of mastering the processes from development to lifecycle management and especially QbD.LernzieleAre you involved in product lifecycle management processes? Stop asking if Quality by Design is mandatory or needed! Our three experts will sensitise you not to underestimate any longer what you can in fact get from it.- To make the most of ICH Q12 opportunities you have to be aware of the relation between ICH guidelines Q8 to Q12 and how to properly integrate them. Its 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.ZielgruppenAny professional in the healthcare industry that is involved in pharmaceutical development and integrated lifecycle management processes - handling regulatory and quality related aspects during the product lifecycle and seeking to keep the pace with latest regulatory strategies - will profit from this online training course.