Audit Readiness - What to expect and how to be ready for an audit?

In this session, we will explore the concept of audit readiness in the pharmaceutical industry. Being audit-ready goes beyond just preparing for inspections; it involves fostering a culture of continuous improvement where compliance and excellence are integrated into every process.

We will cover the purpose of audits, discussing their significance in maintaining high standards of quality and compliance. Understanding the audit process is essential for creating an environment that prioritizes safety and efficacy in pharmaceutical products.

Additionally, we will go over the composition of an audit team, including the roles and responsibilities of team members. You will gain insights into the backgrounds of inspectors, the types of questions they typically ask, and the effective listening techniques for constructive engagement. We will also address the essential do’s and don’ts of communication when interacting with inspectors, which with will help for a positive dialogue and facilitate a smoother inspection process.

Furthermore, we will discuss on how to communicate between the back room and front room, emphasizing the importance of keeping everyone aligned and informed during the audit. Finally, we will cover essential aspects of inspection management, including managing mental and emotional readiness, and improve your effectiveness as a Subject Matter Expert (SME).

Additionally, we will tackle Key Trends to Watch in 2025 that may shape the audit landscape in the pharmaceutical industry.

Join us for an engaging discussion aimed at enhancing our collective knowledge and skills in audit readiness, as we work together to contribute to the integrity and quality of the pharmaceutical industry.

Language

English

Target Audience

Whether you have never encountered an audit, recently experienced your first audit, or are seeking to deepen your knowledge, this session promises to provide valuable insights and practical tips to help you be ready for your next audit. Join us to enhance your understanding and preparedness for audit readiness.

Agenda

17:00 - Welcome

17:15 - Presentation by the speaker Bo Geurts

18:15 - Break

18:30 - Workshop

19:00 - Q&A

19:30 - End

About the speaker - Bo Geurts

Bo has been a Real Staffing Consultant since August 2022, bringing 6 years of experience in quality within the pharmaceutical industry, where she has collaborated with several major players. Currently, she is a key member of the External Quality Team at Johnson & Johnson.

The External Quality Team is responsible for Quality Assurance oversight between J&J and their external partners. They manage various quality systems, including Risk Management and Data Integrity, while supporting Account Owners by overseeing all processes and systems within their domain.

As a Process Owner, Bo proactively and effectively manages the quality systems and processes within External Quality to support global external manufacturers. She oversees critical processes such as Training & Qualification and Document Management, ensuring that the systems remain robust and effective.