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Examining the Q3D Guideline on Elemental Impurities - Online Academy

2 weeks - 2 hour per week

2 week online course beginning on Monday 16th October 2017

Online Academy

This course will provide you with a comprehensive understanding of the ICH Q3D guideline on elemental impurities, ahead of its December 2017 implementation for approved products.

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.

  • 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

What is an Online Academy course?

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.

 

Students will learn through:

• 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

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:

  • Pharmaceuticals professionals working in the arena of toxicology/impurities.
  • The course will also be of interest to regulatory professionals wishing to improve their understanding of the Q3D guideline. 

What happens during an Online Academy course?

o

Specifications for Small Molecule Drug Products Webinar

Led by Dr Mark Powell, a Fellow of the Royal Society of Chemistry (RSC) with over 25 years’ experience as a senior analytical chemist. In 2013, Mark set up Mark Powell Scientific, a company that offers training and consultancy services in analytical chemistry.

The webinar will cover: 
• Regulatory guidance (ICH, FDA, EMA) 
• Tests appropriate to different dosage forms 
• Dissolution specifications for immediate-release, modified-release and extended-release drug products 
• Dissolution specifications in the context of the biopharmaceutical classification system 
• Control of polymorphism, enantiomeric purity, drug-related impurities and microbiological contamination 
• Specifications for combination drug products 
• The role of specifications in maximizing drug product stability

This online academy course can be accessed from Monday 16th October. Two modules will be uploaded per week, allowing you to study at your own pace. Your trainer will welcome any questions that arise throughout your course.

Please note that full payment must be made prior to the course start date in order to receive your login details to begin the course.

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