---
title: "Reducing Compliance Risks in Medical Devices and Biotech: The Value of Audits and Validation"
description: Learn how audits & validation reduce compliance risks in medical devices & biotech, ensuring safety & alignment with regulations. From April 23rd, 2024.
---

Company / News

# Reducing Compliance Risks in Medical Devices and Biotech: The Value of Audits and Validation

**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.

**To view both slide decks from this webinar, click the buttons below:**

**[![View Leah's Slide Deck](https://no-cache.hubspot.com/cta/default/5188904/75e3c9a5-98a5-4bea-84bb-4f35dae62d7e.png)](https://cta-redirect.hubspot.com/cta/redirect/5188904/75e3c9a5-98a5-4bea-84bb-4f35dae62d7e) [![View Renee's Slide Deck](https://no-cache.hubspot.com/cta/default/5188904/60cef3fb-0593-4a97-a84b-0cd1f9afad31.png)](https://cta-redirect.hubspot.com/cta/redirect/5188904/60cef3fb-0593-4a97-a84b-0cd1f9afad31)**

 

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