Webinar
Mar 17, 2021 - Mar 17, 2021

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The analysis of elemental impurities in pharmaceutical products is an important step in assuring quality and compliance. With the implementation of USP chapters <232> and <233> (and subsequent international harmonization), new analytical procedures and validation requirements based on inductively coupled plasma technologies were defined.

However, laboratories in the pharmaceutical industry not only need to make sure their products comply with applicable regulations, but they also need to make sure that data is acquired and stored in a secure and compliant manner. This presentation will highlight the most common challenges around the analysis of elemental impurities (and beyond) as well as useful tips and tricks for setting up the entire analytical system (hardware and software) so that full regulatory compliance is achieved effortlessly.

Key learning objectives:

  • Understand the requirements for analysis of elemental impurities in drug products
  • Find out more about the tips and tricks to make elemental analysis work seamlessly in your laboratory
  • Learn about software tools to facilitate compliance with 21 CFR part 11 guidelines

Who should attend?

  • Analysts tasked with the analysis of elemental impurities
  • Operators who are faced with challenging analyses and are looking for the right instruments to overcome them
  • Lab leaders who want to overcome regulatory challenges and leverage the full potential of their laboratory


Speakers

Daniel Kutscher
Bhagyesh Surekar

Daniel Kutscher
Senior Product Marketing Manager
Thermo Fisher Scientific

After graduation in Chemistry in 2007, Daniel obtained his PhD from the University of Oviedo in 2011. In the same year, he joined Thermo Fisher Scientific in his role as an Application Specialist for ICP-MS. Daniel joined the Product Marketing team in 2018.

 

Bhagyesh Surekar
Product Specialist
Thermo Fisher Scientific

Bhagyesh had completed his post-graduate in analytical chemistry in 2008 from the University of Mumbai, India. He started his career in an analytical testing laboratory and subsequently joined Thermo Fisher Scientific in India as an Application Specialist for AA, ICP and ICP-MS in 2012, working closely with many companies in the pharmaceutical industry.

Currently, Bhagyesh is working at the Thermo Fisher Scientific Center of Excellence for Mass Spectrometry in Bremen (Germany) as a Product Specialist since 2019.

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