Examining the Q3D Guideline on Elemental Impurities - Online Academy from PTI
This four-module online course from PTI provides participants with an essential understanding of the ICH Q3D guideline on elemental impurities - due to be implemented for approved products in December 2017.
Participants will explore, assess and analyse the guideline in depth, looking at the existing implementation challenges and how to create solid risk assessments. Relevant case study examples will also be explored.
The on-demand course format enables participants to access content whenever they need it - providing a flexible approach to professional development.
Suitability - Who should attend?
This course is suitable for pharmaceuticals professionals working with of toxicology/impurities. It may also benefit regulatory professionals looking to develop their knowledge of the Q3D guideline.
Training Course Content
Training course content will include:
- Historical perspective on elemental impurity guidelines and testing
- Introduction to the Q3D guideline
- Understand how this guideline differs from previous regulation
- Applying a risk-based approach to the guideline
- Assessment of options for control
- Other factors – routes of administration
- Case studies based on actual products
- Understand scenarios that can result in elevated levels of EI
- Consider the use of data in future risk assessments
- Implementation guidance for FDA, EMA and Health Canada
- Alignment to Pharmacopeial requirements
- Examining EI in other regions
Why choose PTI
On average, delegates of their online academies said:
Quality of content:
85% had applied content during the course to their role
Please contact PTI for pricing information.
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PTI - Pharmaceutical Training International - Training for the Pharma Industry
PTI is the global leader in professional education for the pharmaceutical industry, delivering a broad course portfolio that covers the industry spectrum: R&D, Clinical Development, Generics, Bio-pharmaceuticals, fine Chemicals, Agro-chemicals, Medical Devices, Animal Health, Manufacturing and Regulations. PTI's open courses,...
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