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Formazione >> Webinar e Formazione Online >> Navigating through the jungle of ISO 11607 - Achieving a packaging validation strategy

Navigating through the jungle of ISO 11607 - Achieving a packaging validation strategy

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FREE ONLINE WEBINAR: To continue supporting our customers' needs this webinar is dedicated to manufacturers only. To allow all interested companies attend, maximum two delegates form the same company will be admitted. Due to the type of event and limited audience capacity, participation of companies not included in this category will not be accepted. Attendance will be confirmed from the event's organizers.

DATE: February 15, 2023 | 3.00 PM - 4.00 PM CET

OFFICIAL LANGUAGE: English

SUBMISSION LINK: https://register.gotowebinar.com/register/7613999711701571166

ATTENDEES CAPACITY: 500 delegates

The event will be hosted within Go ToWebinar platform. Your registration request for this webinar will be submitted to the organizer for approval. You will receive information via email regarding your registration status.

Introduction

You think about sterile and safe packaging of medical devices, and a proper way to show integrity and durability of the packaging system?

This is the right time to consult standards ISO 11607-1 and ISO 11607-2.

Within the upcoming webinar, we want to give you an insight on standards’ requirements on the packaging systems for medical devices. There are several critical points to evaluate and to validate. We would like to provide you with assistance for the validation of sterile, safe packaging systems.

 

Speakers

Lisa Heilemann finished her Master’s degree in Biology Science in 2016. Since then, she set up and performs validations on medical devices under ISO 19227, 11135, 11137 and 11607 for the cleaning, sterilization and packaging of medical devices at Eurofins. Her core area here is the topics of packaging and transport validation, aging studies, qualification of machines, microbiological monitoring / laboratory and systems for water treatment. She has excellent qualifications as an employee in the validation and quality assurance department. Since 2021 she has been part of the dual head, leading the validation department. In order to contribute these skills in exchange with other experts Lisa Heilemann has been part of the DIN standards committee for the packaging and sterilization of medical devices since 2022.

Pascal Ayasse is Molecular Biologist and head of the validation department at Eurofins. He has experience in validating cleaning, sterilization and packaging of medical devices. He himself has set up and performed validation on medical devices under ISO 19227, 11135, 11137 and 11607 for the cleaning, sterilization and packaging of medical devices. He is also Deputy Head of Sterilization of the Eurofins in-house EO sterilization facility and is jointly responsible for the implementation and maintenance of sterilization cycles. Furthermore, he is responsible for routine sterilization and product subordination to the existing sterilization cycles. By supervising a lot of validations he gaining extensive knowledge of regulatory background and testing strategies through client projects.