How RTU Solutions Can Meet GMP Annex 1 Requirements

November 14th, 2024 – 4pm (CET) / 10am (ET)

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How RTU Solutions Can Meet GMP Annex 1 Requirements

November 14th, 2024 – 4pm (CET) / 10am (ET)

Addressed Challenges

  • How Pharmaceutical Companies can be compliant with new regulations and handle Sterility Assurance, knowing that any actions and changes may require significant economic investment and/or could lead to interruptions in production
  • How Pharmaceutical Companies can ramp up flexible sterile capacity across the world with the above premises​
  • How manufacturers can reduce complexity and increase service putting in place mitigation measures to reduce the potential risks of contamination in their final products

Learning Objectives

  • RTU pre-sterilized platforms can aid compliance with EU GMP Annex 1
  • RTU pre-sterilized platforms support pharmaceutical companies in de-risking their operations throughout the process
  • Pharmaceutical Companies and CDMOS can outsource production processes reducing total costs and relying on experienced external partners for non-core activities

Mirko Gabriele

Pharmaceutical and Innovation Consultant

Mirko is a passionate advocate of pharma and innovation, and he is currently bringing this passion in his role of health-tech advisor. He has over 20 years of experience in the Pharma industry predominantly in Technology Transfer and Operations. As a result of his ability to successfully execute all stages of the technology transfer process, he was promoted from site roles to global roles, with the opportunity to work on Technology Transfer Policy harmonization and best practices improvement and sharing. He successfully covered several dosage forms projects, from Oral to Combination products with a strong expertise in Sterile.
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Andrea Salmaso

Regulatory and Scientific Affairs Manager, Stevanato Group

Andrea holds a Pharmacy degree from the Faculty of Pharmacy, Department of Pharmaceutical Sciences, University of Padua (Italy). He is a member of ISO / TC76 / WG2-Rigid container systems and related accessories for Parenterals and Injectables. After a long experience in Quality Assurance in the pharmaceutical industry and medical devices, he joined Stevanato Group, where he held the position of QA Manager for Pre-fillable Syringes production. He is now the Regulatory and Scientific Affairs Manager.
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