Overview
Understand the intricacies of the FDA’s Pre-Determined Change Control Plan (PCCP) and its application across medical devices and in vitro diagnostics (IVDs). This webinar is designed for global regulatory and quality professionals aiming to streamline their strategies for managing post-market device modifications. Attendees will walk away with a deeper understanding of regulatory changes and actionable steps to support compliance objectives and improve efficiency in submissions.
Learning Objectives:
- Understand the FDA’s PCCP framework, how it relates to iterative improvements in software, and its applications for medical devices and IVDs.
- Learn how to prepare effective PCCP submissions with considerations for risk management and post market surveillance documentation.
- Explore strategies for integrating PCCPs into regulatory and product lifecycle planning.
- Identify and address challenges in PCCP implementation.
- Gain practical insights from real-world examples and FDA guidance.
