From Backlog to Control: Building CAPA Maturity for Lasting Inspection Readiness

    A practical framework to regain control of your CAPA backlog

    Clock

    3 PM CET

    Language: English

    Introduction

    This webinar addresses how quality organizations can bring a CAPA backlog under control and, more importantly, build the maturity needed to keep it that way.

    Gain insight into strategies to prioritize by risk, demonstrate real CAPA effectiveness, and put in place the structural changes that turn inspection readiness into a sustained state rather than a last-minute effort.

    About the webinar

    A growing CAPA backlog rarely remains an internal quality issue. When inspectors arrive, overdue investigations, repeated due-date extensions and CAPAs closed without demonstrated effectiveness are often the first signs that a quality system needs closer attention. Yet it remains one of the most common and most underestimated inspection risks, and one of the hardest to resolve.

    This session shares a practical, field-tested approach built on hands-on experience supporting organizations through remediation and inspection preparation. Rather than stopping at how to clear the backlog, our experts also look at how to raise quality management maturity over time, so the backlog is less likely to build up again: from event classification and extension controls to effectiveness criteria, investigation capability and management visibility.

    Attendees will leave with a complete picture of the path from reactive remediation to lasting inspection readiness, including a real-world example of what it looks like in practice.

    What You'll Learn

    • Why a CAPA backlog is one of the most common inspection triggers, and how it undermines an organization's ability to defend its records
    • How to prioritize and segment open CAPAs and investigations by risk, and decide what can be closed quickly versus what requires full reinvestigation
    • How to build a CAPA recovery plan that reduces the backlog without compromising investigation quality
    • What separates a CAPA that is closed from a CAPA that is demonstrably effective
    • Which structural changes help prevent the backlog from building up again, and how to raise your overall quality management maturity
    • What a successful move from backlog to inspection readiness looks like in a real case

    Speakers

    Björn Aalbers

    Founder of Rescop · Managing Partner Strategic Accounts & Country Manager, QbD Group Netherlands

    Björn Aalbers

    Founder of Rescop (now part of the QbD Group), Björn holds a Master's degree in Computer Science from Eindhoven University of Technology and brings a rare combination of deep technical knowledge and hands-on regulatory experience. His career spans international pharmaceutical consulting, IT auditing in GMP and GLP environments, and the development of data-driven software for validation and compliance. He has worked with organisations including Merck, MSD, Organon, Johnson & Johnson, and Genzyme, among others.

    Monique Eilander

    Principal Consultant · QbD Group

    Monique Eilander

    With more than 35 years of experience in regulated industries, Monique serves as Principal Consultant at QbD Group, leading strategic quality management improvement initiatives. Throughout her career, she has held roles as analyst, manager, director, consultant, trainer, and business administrator, building extensive expertise across R&D, Clinical Development, Regulatory Affairs, and Quality Assurance. She specializes in organizational transformation, process optimization, culture and behavior change, and continuous improvement, helping organizations enhance performance while maintaining compliance.

    Bas Michielsen

    GxP Quality & Compliance Consultant · QbD Group

    Bas Michielsen

    Bas Michielsen helps pharmaceutical organizations make their quality systems work in practice. His expertise spans Pharmaceutical Quality Systems, validation and Computer Software Assurance (CSA), process improvement, supplier management, auditing, and data integrity. With a background in quality management and validation, he makes complex requirements understandable and helps teams build clear processes and take ownership. Bas's focus is on connecting people, processes and technology to make quality part of everyday work.

    Who Should Attend

    • Quality Directors and QA Managers
    • QA Officers and Compliance Leads
    • GxP Auditors
    • Validation Leads and Coordinators
    • Heads of Operations and Site Heads responsible for inspection readiness and remediation planning