Don't miss out on an engaging webinar featuring Leah Jones and Renee Mikha as they delve into strategies for minimizing compliance risks through audits and validations.
Leah Jones, CEO
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Renee Mikha, PMP
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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.
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 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.
Please join Voler Systems for this insightful session on April 23 , 2024.