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  6. Announcement of the Webinar on "Key Points of FDA Inspections and Response Strategies"

Announcement of the Webinar on "Key Points of FDA Inspections and Response Strategies"

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last updated:Jan 21, 2025

アガサ
アガサ
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Web seminar to be held on February 7, 2025 (Friday) from 14:00 to 15:30! Introducing a Zoom broadcast.

Agatha Corporation will hold a webinar titled "Data Integrity: Key Points and Countermeasures for FDA Inspections - The Quality Management System Expected by the FDA" online. In this webinar, we will provide detailed explanations of DI violation cases pointed out during FDA GMP inspections, fundamental solutions to DI issues, the establishment of a quality management system, and essential items for supplier audits. Furthermore, in the second part, we will introduce our Agatha solutions and validation support services related to the webinar theme. [Event Overview] ■ Date: February 7, 2025 (Friday) 14:00 - 15:30 ■ Registration Deadline: February 6, 2025 (Thursday) 16:00 ■ Format: Webinar (Broadcast via Zoom) ■ Participation Fee: Free *For more details, please download the PDF or feel free to contact us.

    Technical Seminar
セミナー1.PNG

Announcement of the Webinar on "Key Points of FDA Inspections and Response Strategies"

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セミナー1.PNG
  • Related Link - https://www.agathalife.com/event/20250207_webinar_…

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【Target Audience】 ■1. Quality Assurance (QA) personnel from companies aiming to establish a quality management system in preparation for FDA inspections. ■2. Business executives and leaders considering specific countermeasures against DI violation risks. ■3. Individuals facing challenges in complying with GMP and QMS regulations in the pharmaceutical, health food, and medical device industries.  *Others not listed above are also welcome to participate. *For more details, please download the PDF or feel free to contact us.

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Cloud-based Clinical Trial Document Management System "Agatha Facility Document Storage + IRB"

Cloud-based Clinical Trial Document Management System "Agatha Facility Document Storage + IRB"

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Cloud-based document management system "Agatha eTMF"

Cloud-based document management system "Agatha eTMF"

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Cloud-based Document Management System "Agatha Basic"

Cloud-based Document Management System "Agatha Basic"

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アガサ

アガサ

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Our company provides a cloud service for creating, sharing, and storing documents related to clinical trials and clinical research on a project basis for medical institutions, pharmaceutical companies, medical device companies, CROs, SMOs, clinical testing companies, and more. In addition to offering systems specialized for the medical and life sciences industries, we provide comprehensive support from implementation to operation by staff with expertise in the medical field. Please feel free to contact us if you have any inquiries.

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