Course description
Genotoxic Impurities - Strategies for identification and Control - Online Academy from PTI
Through this four week course participants will gain a crucial understanding of the control of genotoxic impurities (GTIs) in relation to regulatory compliance.
The course will examine the latest updates on regulatory expectations, manufacturers' responsibilities, risk assessments and safety testing. Participants will come away with ideas for implementing effective strategies for identifying, analysing and controlling GIs in their products.
The on-demand course format enables participants to access content whenever they need it - providing a flexible approach to professional development.
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Suitability - Who should attend?
This course is suitable for professionals who are required to identify, analyse, control and/or report on GTIs.
Training Course Content
Training course content will include:
- ICH M7, EMA and FDA guidelines
- Implementation strategies of the ICH guideline for new chemical entities and generics
- Common in silico systems used
- Methods to assess potential mutagenicity impurities
- In-Vitro and In-Vivo tests available to examine mutagenic impurities
- Implementing a successful strategic MI analysis with minimal impact on development times
Why choose PTI
On average, delegates of their online academies said:
Quality of content:
4/5
85% had applied content during the course to their role
Delivery rating:
4/5
Expenses
The cost of this online course is £940 + VAT per participant.