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Elemental Impurities Risk Assessment, Analytical and other Aspects

Conducted by: Dr. Michael Pesachovich
SKU: 191008
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Elemental impurities in drug products may arise from several sources. ICH guidance for industry Q3D Elemental Impurities contains recommendations for manufacturers on applying a risk-based approach to control elemental impurities and PDE.
  • What is a risk-based approach?
  • Should all elements be covered?
  • How do we get the supporting information?
  • What are the appropriate analytical methods and...Continue reading
Elemental impurities in drug products may arise from several sources. ICH guidance for industry Q3D Elemental Impurities contains recommendations for manufacturers on applying a risk-based approach to control elemental impurities and PDE.
  • What is a risk-based approach?
  • Should all elements be covered?
  • How do we get the supporting information?
  • What are the appropriate analytical methods and what is appropriate to test?
  • How sensitive the analytical method should be, quantitative or limit test, validated or not?
  • Can heavy metal test be completely omitted, and how to manage the existing monographs?
  • How frequently should we test (each batch, periodic or not at all)?
  • Change control and life cycle management of monographs, risk assessments and analytical methods.

These and many other questions will be discussed during the course.

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Date:  3 December, 2019
Course location: Kfar Maccabiah, Ramat Gan
Duration: 1-Day Course
Hours: 09:00 - 17:00
Credits: 1
Course Language: עברית

Course price: ₪1,850 + VAT
Early registration is Closed
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Issues to be covered

  • Evolution of Elemental impurities requirements
  • Elemental impurities in APIs, components and final products
  • Analytical methodologies
  • Approaches to prepare the risk assessments
  • Workflows and Decision trees
  • Life-cycle management – post risk assessment elemental impurities management

 

Who should attend

  • Pharmaceutical and API R&D
  • Quality Control
  • Quality assurance
  • Regulatory affairs

Benefits to the Participants

  • Analytical, Quality and Regulatory compliance
  • Streamlining the internal processes and avoidance the redundant work

About The Lecturer

Michael Pesachovich
Founder AequitaLab LTD. Michael (M. Pharm, Ph.D. Org. Chemistry, Registered
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