Practical session – Risk assessmentUsing real process examples to explore the conduct of such assessments and to examine how to use such tools to define a robust GI control strategy for the product concerned.
Practical session – Interpretation of output from in silico systemsExamining the in silico predictions for a series of molecules and to use this to judge the genotoxic potential of the impurities concerned.
Practical session: Analysis of genotoxic impuritiesBased around actual GI related problems - delegates will be presented with details of the problem and asked, in each case, to develop an appropriate analytical strategy to resolve it.
Interactive discussion sessionAn opportunity for participants to raise any questions they may have relating to GIs and to discuss these both with the workshop leader and with other participants.
The control of genotoxic impurities is crucial for ensuring regulatory compliance. With the implementation of increasingly stringent regulations for impurity levels, it is more important than ever for drug manufacturers to employ effective strategies for identifying, analysing and controlling GIs in their products.
Led by Andrew Teasdale this course will provide you with the latest updates on regulatory expectations, clarifying any grey areas to outline your responsibilities as the manufacturer. It will also advise on crucial aspects of risk assessments and safety testing.
Using a combination of theory and practical case studies, the course will allow delegates to develop the knowledge needed to overcome everyday problems and enhance performance, ensuring you are employing the most appropriate analytical strategies for your products.
This course is relevant to anyone involved in identifying / analysing / controlling / reporting of GTIs including those working in:
• Analytical Chemistry/Validation/R&D
• Development Chemistry
• Genetic Toxicology
• Laboratory Management
• Pharmaceutical Development
• Regulatory Affairs
• Safety Assessment
Connect with the PTI faculty! PTI is a global pharmaceutical training company with over 60 interctive courses focusing on Regulatory Affairs, R&D, Clinical, Business Strategy, Fine Chemicals, Biopharmaceuticals, Manufacturing, Medical Devices and Agrochemicals