Impurities Workshop Part I: General Strategies for Identification and Control of Impurities - Live Online Training
Tuesday, 18 October 2022 8 .30 - 17.15 h
Course No. 20036
Speakers
Dr. Xaver Schratt
GBA Pharma
Dr. Gerd Jilge
Formerly Boehringer Ingelheim,
All times mentioned are CEST.
Objectives
Part I of the Impurities Workshop will provide an opportunity to reinforce and expand your knowledge of the general area of impurities in chemical entities from initial development to the market with emphasis on
Detection, profiling and control of impurities in drug substances, intermediates and drug products
Practical aspects of method validation for impurities determination
Analytical techniques used for detecting and qualifying impurities
Extractables and Leachables as a source of impurities
Approaches for investigation and determination of unexpected impurities
This Live Online Training is designed to provide a comprehensive review of impurities analysis and characterisation in drug substances and drug products and their recording and reporting.
Background
Setting specifications for impurities are one of the most critical topics in the development of new drug products. Impurities analysis in drug substances and drug products and their recording and reporting is quite often a challenge for the scientific experts in routine production and quality control. This challenge is even bigger when profiles of unknown impurities in complex matrices have to be established. The Sartan case made clear the importance of a thorough process understanding.
Target Group
This Live Online Training is addressed to all personnel involved in development of drug substances and drug products from scientific staff to laboratory heads involved in R&D. The needs of Laboratory Managers, Supervisors and Analysts in pharmaceutical quality assurance and quality control departments will also be covered. This Live Online Training will also address regulatory requirements and hence is applicable to people working in the regulatory affairs area.
Technical Requirements
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Seminar Programme as PDF