Description: As medical device innovation accelerates, managing postmarket changes through traditional regulatory pathways can hinder iteration and delay product innovation. Predetermined Change Control Plans (PCCPs) offer a proactive solution that streamlines lifecycle management, reduces regulatory burden, and allows for faster implementation of changes to support innovation. This session will provide a practical guide to strategically planning, developing, submitting, and implementing effective PCCPs. Drawing from real-world experience, the session will walk attendees through the key elements of a PCCP. Attendees will learn how to structure effective PCCPs aligned with FDA expectations. The session will highlight best practices for PCCPs and avoiding common pitfalls. Participants will also learn best practices for coordinating with cross-functional teams. Whether you’re exploring PCCPs for the first time or aiming to optimize your next submission, this session will equip you with the tools and strategies to confidently apply PCCPs and unlock their full potential within your organization.
Learning Objectives:
Learn how to structure and develop effective PCCPs that align with FDA expectations
Apply best practices and avoid common pitfalls in the planning, submission, and implementation of PCCPs
