This course will provide you with a comprehensive understanding of the ICH Q3D guideline on elemental impurities, to help you implement it effectively.
Over four modules, you will examine the guideline and its scope in depth, evaluate the current challenges in implementation and receive guidance on constructing solid risk assessments. You will also be guided through relevant case study examples. The course will cover:
Andrew Teasdale PhD has over 20 years’ experience in the pharmaceutical industry as an analytical chemist and within quality assurance and regulatory roles. In his current role, he chairs AstraZeneca’s Impurity Advisory Group. Dr Teasdale has published a number of papers relating to elemental impurities and other impurity-related matters, and has been a speaker at many international conferences. Dr Teasdale has also led a number of industry expert groups. These include both safety and quality groups within Pharmaceutical Research and Manufacturers of America (PhRMA), European Federation of Pharmaceutical Industries and Associations (EFPIA), Product Quality Research Institute (PQRI) and the Extractables and Leachables safety Information exchange (ELSIE). He also helped establish a cross industry group dedicated to the development of an elemental impurity database for excipients and is currently the leader of the IPEC EU ICH Q3D Implementation taskforce. He has also presented industry case studies on behalf of EFPIA at 2 day ICH Q3D meeting with European Medicines Agency (EMA).
• Gain a comprehensive overview of the guideline’s origins
• Understand the requirements in detail
• Step-by-step exploration of risk assessments
• Evaluate the options for control
• Consider key challenges and likely future developments
• Ground this knowledge using actual product case studies
This course has been designed so that you don't have to take much time out of the office, therefore is perfect for individuals or groups from the same department to attend at the same time.
This course is designed for professionals working in the following areas:
Online academy is a new online, interactive and engaging education tool designed to maximise learning for professionals with busy schedules and/or small training budgets.
The online academy brings alike professionals together and gives you the opportunity to share ideas and questions via the discussion forum creating your own professional community. Our on-demand feature means the content is available as and when you need it allowing greater flexibility to your professional development and learning.
• 4 modules, split up into multiple bitesize recorded videos
• Quizzes to test your knowledge
• Revisit the content with unlimited access to all the materials for 2 months
• Access the discussion forum and interact with other students and the trainer
• Direct contact with the trainer through the forum during the 4 weeks the course is running
• Additional content such as slides and white papers available to download
Once you have registered you will be given login details to access the course