Stability Testing of New Drug Substances and Products Q1A (R2)WebinarRegister now!To improve the quality of the pharmaceutical products and to ensure that safe, effective and high quality medicines are developed the International Council for Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has developed the ICH quality guideline ICH Q1A (R2). This guideline covers the Stability Testing of New Drug Substances and products and determines the stability data package which are sufficient for a registration application within the three regions of EC, Japan and the United States. In this Webinar we will follow the content of the guideline and we will emphasize the stability testing criteria which will have to be followed for a successful stability testing procedure according to the valid guideline. There will topics as forced degradation studies, long-term and intermediate testing as well as accelerate testing considered. Furthermore most important factors of climate chambers to be used for stability testing are pointed out. Presented by:
Andrea Weiss Andrea Weiss is Senior Area Manager and Product specialist at Memmert for more than 15 years and in charge of South East Asia. Holding regularly product trainings and customers seminars. Certified management assistant in foreign trade and commercial correspondent with profound technical knowledge on Memmert products. My passion for the technique and the diversity of the Memmert products helps me with my personal ambition to give best support to our customers and to assist them to find the solution, which is mostly suitable for their application.
|
|
Traitement de votre demande ... |
