Webinar Date: April 23rd, 2024
Speakers: Leah Jones, CEO, QAConnect Mgmt Consulting & Renee Mikha, PMP Principal Consultant InsightQual Consulting Inc.
Details: Leah discusses internal, supplier, and process audits per ISO 13485, 21 CFR Part 820, and ISO 14971 regulations. She reviews 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 discusses 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.
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