How RTU Solutions Can Meet GMP Annex 1 Requirements

Pre-sterilised ready to use containers as a compliant aseptic solution, reducing contamination risk and simplifying EU GMP Annex 1 compliance.
Date
November 14th, 2024
Time
4pm (CET) / 10am (ET)
View Linkedin Event
Presented by:

About This Webinar.

The current EU GMP Annex 1 emphasizes the importance of handling critical manufacturing steps and managing risks associated with contamination. It is crucial for pharmaceutical companies to align their quality management system and establish appropriate Contamination Control Strategy (CCS) and Quality Risk Management (QRM).

By choosing Ready-To-Use (RTU) containers, pharma companies can remove critical operating units and significantly automate their manufacturing process and reduce human intervention, minimizing potential risks of contamination connected to the washing and depyrogenation phases, making operations leaner, and allowing pharmaceutical companies to focus on key activities with the most added value.

In this webinar we discover how RTU containers can be a smart solution to aseptic manufacturing challenges, meeting regulatory requirements and reducing the risk in client’s operations throughout the process with EZ-fill® platform, a fully integrated pre-washed and pre-sterilized containment solution for aseptic manufacturing.

We will deep dive into the benefits for Pharma Companies of adopting RTU solutions:

  • Reduced contamination sources
  • Reduced Total Cost of Ownership – simplified CCS implementation and reduced costs of Isolation Technology
  • Preserved container quality for patients’ safety
Reserve Your Seat

Built Around the
Challenges You Face.

Addressed Challenges
Achieving compliance with revised GMP Annex 1 sterility requirements while managing the economic and operational impact of necessary process changes. 
Scaling flexible sterile manufacturing capacity globally while maintaining contamination control standards and regulatory compliance at every site. 
Reducing process complexity and implementing effective contamination mitigation measures to protect the quality and safety of final injectable products. 
WHAT YOU WILL LEARN
Understand how RTU pre-sterilised platforms support compliance with EU GMP Annex 1 by eliminating critical washing and depyrogenation process steps. 
Learn how RTU solutions help pharmaceutical companies de-risk sterile manufacturing operations and reduce contamination exposure throughout the process. 
Discover how outsourcing to experienced partners using RTU platforms can reduce total cost of ownership and allow focus on core manufacturing activities. 
RTU GMP Annex 1 Webinar

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.

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.

Meet the Speakers.

Free to attend.
Limited places.

November 14th, 2024

4pm (CET) / 10am (ET)

Reserve Your Seat

<span>By ticking this box, you agree to the privacy policy of <a href=”https://www.stevanatogroup.com/it/privacy-policy/” style=”color:white; text-decoration: underline;” target=”_blank”>Stevanato Group</a> consenting to receiving communications related to this topic and other products or services within their portfolio</span>

  • Thank you for your registration