IT Infrastructure Qualification for Small & Medium Medical Devices Companies (and SaMD): ISO 13485:2016 Compliance
Overview:
Networking opportunities are crucial at events, aren't they? However, many online events or webinars lack the chance for interaction not just with the speaker but also with fellow attendees, right?
This webinar presents a unique approach. Here's how it works:
Upon free registration, you can choose whether to share your LinkedIn ID with other participants. Please note that sharing is entirely optional, and we'll respect your decision.
If you share your LinkedIn IDs, you'll receive a list of registrants, including their profiles, up to 2 days before the event.
During the Zoom webinar, the moderator will enable microphones, cameras, chat, and Q&A sections. This means you can send messages to specific individuals, the entire audience, or even the speaker and moderator. Isn't that incredible?
Enjoy the benefits of an online event with effective networking opportunities, knowing who will attend it! It's remarkable!
To facilitate this, please note that this is a B2B event, and participation is limited to registrants with corporate email addresses. FIVE Validation reserves the right to reject registrations from professionals using personal emails or those not aligned with the company's mission and vision.
Now, let's dive into the topic we'll be discussing at the event: IT Infrastructure Qualification for Small & Medium Medical Devices Companies (and SaMD): ISO 13485:2016 Compliance
Target audience
Mainly QA and IT managers of small & medium device companies (and SaMD).
What we will discuss
The following topics will be covered:
- What is IT infrastructure qualification?
- Importance for small & medium medical devices companies
- Infrastructure qualification as a requirement of ISO 13485:2016
- IMDRF
- Impact of unqualified infrastructure
- IT infrastructure control
- How to ensure the right content for IT infrastructure qualification
- How to ensure the content for a consistent validation project
- What is about using a digital validation approach?
Who is promoting this event?
FIVE Validation: it provides a SaaS-based platform tailored to empower Life Science companies, facilitating a sixfold enhancement in the speed and effectiveness of validation studies. This capability holds significance within the (bio)pharma and medical device sectors, where validating processes and systems is crucial for ensuring compliance with EMA and FDA regulations.
Also specialized in providing services in computer system validation, equipment validation, utility qualification, and IT and OT infrastructure qualification. With a track record of serving +200 clients across +1,000 validation projects.
clients across
validation projects
Speaker
Silvia Martins – FIVE Validation
Silvia Martins, electrical engineer, with +20 years of experience in serving (bio)pharmaceuticals and medical devices companies. Trained in England in GAMP5® and FDA 21 CFR Part11, in Germany in SAP® validation, and Denmark in data integrity and data governance. As the CEO and co-founder of FIVE Validation, a company committed to simplifying compliance processes, Silvia is dedicated to expediting and streamlining procedures for clients while maintaining a high level of robustness and compliance.
Moderator
Lilian Ribeiro – FIVE Validation
Lilian Ribeiro is a chemical engineer with a decade of technical and commercial expertise in the food industry, with a specialization in corporate quality and quality control. She also has valuable experience in the health and pharmaceutical sectors. As an advocate for digital validation, she is passionate about introducing efficiency and innovation to life science companies. Lílian's extensive experience is instrumental in validation and qualification projects, encompassing VLMS, ERP, EQMS, automation (PW), and IT infrastructure qualification.
