Mastering QMS Audit Readiness: Strategies for Preparation, Conduct, and Mitigation

Mastering QMS Audit Readiness: Strategies for Preparation, Conduct, and Mitigation Webinar

Join us for an insightful webinar where we’ll delve into comprehensive strategies and tactics to help ensure your organization is prepared for your next audit.

Date: Monday, April 15, 2024
Time: 4pm to 5pm PT
Platform: Zoom

In this dynamic session, our expert speaker will guide you through the entire audit lifecycle, covering crucial aspects such as:

1. Pre-Audit Preparation: Gain actionable insights into preparing your facility and personnel for a successful quality system audit. Learn how to ensure readiness, establish best practices, and optimize cross-functional team collaboration to streamline audit preparations.
2. Front Room and Back Room Management: Discover effective strategies for managing interactions with auditors (front room) and coordinating behind-the-scenes operations (back room) during the audit process. From responding to inquiries to retrieving requested documents, you’ll learn how to maintain professionalism and efficiency throughout.
3. Audit Finding Mitigation: Explore proactive approaches to mitigate audit findings and enhance audit outcomes. Learn how to identify potential issues, address auditor questions with confidence, and implement strategies that helps to mitigate/de-escalate findings and observations. The speaker will share real-life cases and scenarios to facilitate your understanding.

This webinar is essential for Quality & Regulatory Directors and Managers, Quality & Regulatory personnel supporting a QMS audit, as well as any job functions that are involved in a QMS audit. Don’t miss this opportunity to gain invaluable insights and actionable strategies to elevate your organization’s audit readiness and effectiveness.

Register now to secure your spot and empower your team for audit success!

About the Speaker:

Julie Manchester, Senior Director Quality Assurance & Regulatory Affairs, The HydraFacial Company

Julie Manchester is a seasoned leader with over 15 years of experience in quality and regulatory affairs across biotech, medical devices, pharmaceuticals, and other industries. Holding a Bachelor of Science from UC Riverside, she is an ASQ Certified Manager of Quality/Organizational Excellence (CMQ/OE) and holds a RAPS Device certification. Julie is deeply engaged in community and industry leadership roles, serving as committee members for OCRA, RAPS, and ASQ, contributing to industry standards and best practices. She also serves the board of the VietNam Scholarship Foundation, and as an Advisory Committee Member for the Women of Leadership Program at the University of Richmond. Throughout her career, Julie has excelled in building, leading, and executing quality management and regulatory programs, ensuring adherence to quality standards and regulatory compliance in international markets, and has hosted over 250 audits including regulatory body audits and inspections, such as the FDA and Notified Bodies, technical/safety audits, customer audits and more.

Register Now!

Free to OCRA member
$20 for nonmember
Register for your team of 5+ participants? Please email programs@ocra-dg.org.

Thank you to our Silver Sponsors!