null EDQM Training Module 3: Impurity Control in the Ph. Eur.

EUROPEAN PHARMACOPOEIA 01/07/2021 ON-DEMAND WEBINAR

Impurity control is an essential aspect of quality control in individual monographs of the Ph. Eur. In this module, you will learn about the Ph. Eur. policy on impurity control. It will cover all types of impurities, whether they are organic, inorganic (including elemental impurities), solvents or DNA-reactive impurities such as N-nitrosamines.

You will also learn about analytical procedures used, specification setting, the correct use of reference standards and the link between individual and general monographs and general chapters and their mandatory or non-mandatory nature. In this context, the implementation of the relevant ICH guidelines and their importance for the Ph. Eur. will also be discussed. The recording includes a Q&A session. 

Download the programme

Target audience

The modules is of interest to all personnel involved in drug development, R&D, pharmaceutical quality assurance and quality control, as well as those working in regulatory affairs.

It is ideal for those looking to build a solid foundation knowledge of both the Ph. Eur. and the Certification procedure, for example, newly graduated or early-career professionals.

WATCH NOW

Duration: 1 hour, 30 minutes

Download the presentation

Other Events / Training Sessions

On-Demand Webinars

 Suggested Viewing/Reading

The EDQM recommends participants watch and read the pre-training materials listed below before joining a training module. The materials will help participants familiarise themselves with some basic concepts and topics which will not be covered in detail in the webinar sessions.

FAQ & Helpdesk