
안녕하세요, ㈜영사이언스입니다.
STERIS에서는 국내 고객분들 위해 도움 되는 여러 개의 EU Annex1 시리즈 웨비나를 준비하였습니다. 아시아 지역 시간대에 맞추어 진행 예정으로, 고객님들에게 도움이
되었으면 합니다.
자세한 내용은 아래의 내용을 참고해 주시기 바랍니다.
감사합니다.
㈜영사이언스
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Implementation of a Contamination
Control Strategy for Compliance with Annex
1
Presented by STERIS Life Sciences
Tuesday, 25 April
2023 | 11 a.m. – 12 p.m. CST (GMT+8)
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Our
complimentary webinar series will provide information
on the new guidelines established in the final version
of Annex 1.
The first
webinar in our series presents an overview of the
contamination control strategy (CCS) process in a
medicinal production facility. We introduce the
European Compliance Academy (ECA) template as a tool
for documenting the CCS process with examples of
elements to consider, including cleaning,
decontamination, sterilization and sterility
maintenance.
The
webinar also covers an overview of Annex 1 changes in
contamination control and a discussion of challenges
manufacturers may face with the holistic CCS approach. We discuss how to leverage modern
technology (e.g., software, virtual reality) and
statistical analysis to overcome these
challenges. Finally, attendees
will participate in a survey to share their
experience and benchmark
status regarding Annex 1
implementation.
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Don’t Miss the Other Webinars in Our
“Navigating Annex 1” Series
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