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Lecture

The Influence of Compliance Requirements on Project Management in the Life Science Industry

19/02/2025 07:57:00

hybrid
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Event Information

Everything you need at a glance: schedule, attendance details, fees, and professional development credit.

Schedule

Start: 19/02/2025 07:57:00

Fees and access

Attendance mode: hybrid

Event logistics

Starts: 19/02/2025 07:57:00

Attendance mode: hybrid

Event Details

This presentation explores the impact of compliance requirements on project management in the life sciences sector, with a specific focus on the Pharma and Med Tech industries. It connects the stringent regulations governing these fields (such as Gx P, FDA CFR Part 11, and GDPR) to their influence on how projects are executed.

We will examine the practical implications of compliance for areas such as project planning, risk management, validation, and IT system governance.

Through real-life examples from industry-leading companies, we will demonstrate how compliance challenges arise in projects and how teams effectively address them. Additionally, we will share best practices and tools that streamline compliance and validation processes, making them more manageable.

Finally, we will explore emerging trends in the field, including advancements in AI, automation, and the continuous evolution of the compliance landscape.

Speaker Profile

Mathieu Luethi is a seasoned project management consultant with extensive expertise in IT-driven business projects, particularly in the pharmaceutical, medical device, and insurance sectors. Over the years, he has collaborated with renowned companies such as Novartis, Alcon, and Sandoz, focusing on international ERP implementations, methodology development, regulatory compliance, and project quality management.

As the owner of Swiss Frame Works, Mathieu specializes in assisting clients with regulatory compliance challenges, including FDA CFR Part 11 and ISO 13485, while ensuring projects remain on track. He also provides coaching to project teams on compliance and project management methodologies and conducts comprehensive program and project audits.

Mathieu holds certifications such as Project Management Professional (PMP) and Agile Certified Practitioner (ACP), equipping him with the flexibility to manage projects using Waterfall, Agile, or Hybrid methodologies.

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