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20 May 2021



An industry perspective on the qualification of impurities and degradation products to meet RDC 53, ICH M7, Q3A and Q3B guidelines


Lhasa Limited Webinar RDC 53 ICH M7 Q3A Q3B Zeneth

We were delighted to be joined by pharmaceutical and regulatory based industry professionals from the Brazilian market to talk about qualifying impurities and degradation products in line with the RDC 53 guideline. 

This extended webinar session took place over the course of an afternoon, and was predominantly spoken in Portuguese. 

Speakers and presentations from the event are as follows:

  • Guest Speaker: Maria Augusta Carvalho Rodrigues, ANVISA
  • Presentation title: Qualifying impurities and degradation products: Anvisa’s experience and technical improvement
  • Guest speaker: Fernanda Waechter, Lhasa Limited
  • Presentation title: Risk Assessment of Potential Mutagenic Impurities in Anti-hypertensive Drug Products Approved in Brazil
  • Guest speaker: Dr. Mariah de Almeida Ultramari, Spektra Consultoria
  • Presentation title: Case Studies on the Qualification of Impurities
  • Speaker: Alex Vrijheid, Lhasa Limited
  • Presentation title: A practical demonstration of using Zeneth to predict for degradation and excipient compatibility to support the RDC 53 guidelines 

To view the slides and recordings please see below, or for more information, get in touch.

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VAT number 396 8737 77 | Lhasa Limited is registered as a charity (290866)| Company Registration Number 01765239 (England and Wales).

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