Marco Prado, Novartis Pharma AG - Qepler Summits And Conferences

Marco Prado

Global Head Quality Medical Devices - NTO BT&A QMS
Novartis Pharma AG
Basel, Switzerland
Novartis is a global healthcare company based in Switzerland that provides solutions to address the evolving needs of patients worldwide.

Marco is the appointed Management Representative and accountable for the ISO 13485 certification for Medical Devices for the global Head Quarters at Novartis Pharma AG, Basel. This connects as well with the lead and coordination of the implementation of the ISO strategy as it expands across Novartis.

Marco’s team is responsible also for the medical devices input into QMS; global projects e.g. EU MDR and support to other line functions.

Marco started his career as a microbiologist in research and commercial antibiotic production. His 27 year journey with the Novartis group companies started in Brazil as head of sterile production, later expanded to oral liquids and semi-solids production.

Since 2003 Marco has been at the headquarters in Basel in Quality roles ranging from global roles for manufacturing sites and country organization oversight to Head of TRD QA Switzerland.

He obtained his diploma in Pharmacy-Biochemistry at the University of São Paulo (Brazil) followed by a MBA at Fundação Getúlio Vargas (São Paulo, Brazil).

Related Sessions:

2nd Annual Drug/Device
Combination Products Summit 2019

Get up to date with the regulatory and quality compliance strategies for combination product development.
  • 04 Dec 2019
  • Prague, CZ
  • Pharma
Day 1: Wednesday, 04 December 2019
CASE STUDY: Workshop.

This workshop will provide an overview of the journey and lessons learnt by the first company to achieve a certification of their QMS system and product against the EU MDR. The presentation will be focused in two parts – firstly an overview of the adaptation of the quality system to incorporate and address the elements required under the MDR followed by a discussion and reflection of the challenges and strategies used to successful upgrade and certify an inhaler device platform supporting both commercial and development products.

  • Strategy used to adapt a quality system to the MDR.
  • Gap assessing your quality system and implementing a plan to adapt and upgrade to continuously improve and meet the MDR and other Global HA requirements.
  • What does ready look like? Key lessons learned on the transition.
  • Discuss the product strategy employed and the challenges faced in adapting a legacy platform product to the MDR, which also required an up classification.
  • Outcomes, challenges and strategies for transition and implementation.
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