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2026 Webinar Series: FDA Audits Unwrapped: A Beginner’s Guide for Tissue Banking Professionals (Part 1) (Group)

Includes a Live Web Event on 01/14/2026 at 2:00 PM (EST)

Description: Stepping into tissue banking or a new quality role can feel overwhelming—especially when FDA audits enter the picture. This webinar breaks down the audit process in clear, practical terms designed for newcomers. Learn what auditors look for, how to prepare, and the common pitfalls seasoned professionals wish they had known earlier. We’ll also walk through how to locate, interpret, and leverage FDA 483s and Warning Letters to strengthen your quality systems and prevent repeat issues. Perfect for new hires, new quality staff, or anyone seeking a solid foundation in regulatory expectations



Target Audience: This webinar is for early-career quality professionals, new hires in tissue recovery or processing organizations, and staff seeking a foundational understanding of FDA audit expectations, 483s, and Warning Letters within the tissue banking environment.








Jackie Warn, MBA, CMQOE

Chief Quality and Regulatory Officer

Surgenex, LLC

Jackie Warn is a seasoned leader with nearly 30 years of experience driving quality, regulatory compliance, and performance excellence across diverse sectors, including biotechnology, tissue banking, healthcare, and laboratory operations. Renowned for her strategic vision, she has led the development and implementation of enterprise-wide regulatory affairs and quality management systems, ensuring strict adherence to top-tier standards while advancing operational efficiency. An active contributor to the field, Ms. Warn serves on multiple committees and councils within the American Association of Tissue Banks. She holds an MBA, a BS in Business Administration, and an AAS in Medical Laboratory Technology. Her professional certifications include CMQ/OE from the American Society for Quality and MLT from the American Society of Clinical Pathologists.

Jennifer Drago, CTBS, CQM/OE, CQA

Quality Manager

Rocky Mountain Tissue Bank

Jennifer Drago has over 15 years of combined experience in Quality and Regulatory Affairs in blood banking, medical devices, and tissue and organ procurement. She has served as the AATB Quality Council leadership since 2017 and has participated as a member of the Quality Council Change Control Subgroup. Jen is a CTBS, Certified Quality Auditor, a Certified Manager of Quality and Operational Excellence, and has her Six Sigma Yellow Belt Certification.

Laurie Agle, CTBS

Senior Director, Quality Systems

Vivex

Laurie Agle, BS, CTBS, has been in Tissue Banking for over 20 years working in call centers, recovery, training, and is currently the Senior Director of Quality Systems at Vivex Biologics.  Laurie is on the Quality Council and is the Vice-Chair of the Certification Committee with previous service on the Ethics Committee and several AATB task forces.

Amber Dean

Quality Systems Manager

We Are Sharing Hope SC

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2026 Webinar Series: FDA Audits Unwrapped
01/14/2026 at 2:00 PM (EST)  |  60 minutes
01/14/2026 at 2:00 PM (EST)  |  60 minutes
2026 Presentation Evaluation
7 Questions
Certificate of Attendance
1.00 credit  |  Certificate available
1.00 credit  |  Certificate available