What we’re about
This MeetUp is for people deeply interested in the enabling technologies and architectures which are enabling the Internet of Things, Wearable Devices, and other sensor-based products and solutions. From new sensor technologies to new integrated solutions, it brings together people looking at how global trends will impact Silicon Valley ventures, and how Silicon Valley can engage tap into market and technology trends worldwide.
Upcoming events (1)
See all- Reducing Compliance Risks in Medical Devices and Biotech: Audits and ValidationLink visible for attendees
Voler Systems invites you to join us on Tuesday, April 23, 2024, for an engaging webinar featuring Leah Jones and Renee Mikha as they delve into strategies for minimizing compliance risks through audits and validations.
Leah will discuss internal, supplier, and process audits per ISO 13485, 21 CFR Part 820, and ISO 14971 regulations. She will review the framework of the risk-based approach to auditing, and why it is beneficial to medical device companies. Plus, the need to ensure that risk aligns with company goals.
Renee will discuss how validation activities and data integrity are important for ensuring safety and efficacy of computerized systems and quality management systems, including 21 CFR Part 11
compliance. Plus, the benefits and bottom line for customer satisfaction.Sign Up to Attend: https://info.volersystems.com/reducing-compliance-risks-in-medical-devices-and-biotech-the-value-of-audits-and-validation
Speakers:
Leah Jones, CEO of QAConnect Mgmt Consulting:
Leah has 19 years’ experience working in Quality in medical devices and biotechnology within IVD (in-vitro diagnostics) Class I, II, and III devices. She is a certified quality auditor, six sigma and Kaizen expert. She is a published writer and has been featured in American Society of Quality’s QP Magazine (Improve with Kaizen) and is a content writer for Master Control (FDA’s software vendor).Renee Mikha, PMP, Principal Consultant at InsightQual Consulting Inc:
Renee is a Certified Project Management Professional (PMP), supporting Medical Device companies to meet FDA regulatory requirements, by delivering compliance solutions (Computer System Validation, Data Integrity Assessments, IT Vendor assessments, Audits) for quality management systems, document management systems, ERP(SAP), Lab systems, clinical trial management and Manufacture.Once you sign up for the event, you will receive a Zoom link and Meeting ID in where you can use to access our virtual event.
Please feel welcome to spread the word about this event with your partners and colleagues you'd like to invite!
If you have any questions or need any help, please contact us at (408) 334 - 6801 or otherwise at bryan.torres@volersystems.com.
Thank you. Looking forward to seeing you there!
