7 March - 15:00 -16:00 GMT / 16:00 – 17:00 CET

Ready, set, go! A practical guide to empower your organization with a Quality Management System 


Balancing easy access to data, a fast internationalization and operational efficiency with product quality and compliance is a demanding task for life sciences organizations. To ensure regulatory compliance and to manage constantly increasing requirements, a steadily growing number of them decide to implement a Quality Management System (QMS). However, even the best QMS cannot completely fulfill its purpose if the underlying internal business processes are not set up properly and/or are outdated. Just as a house must be built on a stable foundation, your business requirements should also form the optimal basis for the new system to be implemented.

That is why EXTEDO and Epista Life Science, have joined forces to support you in a successful QMS implementation. Join this webinar to learn about a “Phase 0” approach to creating a harmonized IT backbone for your company. You will be ready for QMS configuration questions, and you will end up with a QMS that supports your business rather than the other way around. In the live demo of EXTEDO’s Quality Management solution, the participants will also learn what to consider when implementing a new system to be fit for the future and which features and capabilities a QMS provides. Learn more about the benefits of a QMS as part of a comprehensive RIM platform, visit EXTEDOpulse - A Comprehensive RIMS Platform for Life Sciences | EXTEDO.

Agenda
- Introduction of topics and speakers 
- Oliver Bosch, Principal Consultant at Epista DACH region, will explore a unique “Phase 0” approach to explain the step-by-step process of implementing a QMS tailored to Life Science organization and its strategic importance:
o Look ahead to create harmonized business processes aligned with your business goals
o Results in an efficient implementation and roll-out
o Provides a system that adds value to your company, right from Go-Live

- Nicole Sagner, Senior Pre-Sales Manager at EXTEDO, will demonstrate EXTEDO’s Quality Management solution as part of the EXTEDOpulse RIM platform
- Our experts will share experiences from ongoing QMS projects, supporting you with some best practices and how to navigate challenges
- Q&A Session 

Target Audience
Regardless of whether you come from the IT, QA/QM, Manufacturing, or Product Development area, this webinar is tailored for all professionals in the Life Science sector who want to raise their organizational standards and unlock the transformative power of a QMS. If you are taking your first steps toward QMS implementation, this webinar provides valuable insights and practical guidance for achieving success.

Learning Outcomes
In this webinar, the EXTEDO and Epista Life Science experts will give valuable insights into the QMS implementation, focusing on eliminating uncertainty. The session will provide a comprehensive overview of the necessity of a QMS by illustrating the bigger picture and showcasing the different steps of a QMS implementation project. Through a live demonstration, the attendees will learn more about the key features and capabilities of the EXTEDO QMS software, gaining practical knowledge. Additionally, they will learn how a QMS can support to effortlessly manage quality processes such as document control, quality events, CAPA, training management and much more.

Speaker Details


Nicole Sagner, Senior Pre-Sales Manager at EXTEDO
As a Senior Pre-Sales Manager at EXTEDO since 2021, Nicole is responsible for presenting our products and newest features to customers and interested parties, but also gathering requirements to improve our products further and make them fit for the future. In addition to her role as Senior Pre-Sales Manager, Nicole brings several other qualifications, including being a Regulatory Affairs Manager, Professional Software Trainer, and Regulatory Consultant. In her past business life, she has been responsible for preparing and executing customer trainings for Regulatory Information Management System, supporting customer implementation projects, regulatory and xEVMPD relevant data administration and xEVMPD data transmissions. 


Oliver Bosch, Principal Consultant at Epista
Oliver is one of Epista’s Principal Consultants throughout the DACH region. He has +10 years of experience in consulting the life science sector, from industry to authority, with system architectures and implementations. He has a wide experience with multi-functional projects across the R&D sector, combining quality, information technology and business.

About EXTEDO and Epista Life Science
EXTEDO is your trusted bridge between industry and agency. With EXTEDOpulse, we provide a comprehensive end-to-end Regulatory Information Management System (RIMS) that increases the efficiency of regulatory processes while guaranteeing compliance. Additional services (publishing, submission, etc.) complete our offer.  

Epista Life Science's professional team operates at the confluence of corporate objectives and regulatory mandates. Leading the way in innovating methodologies, we support our customers in discovering, choosing, integrating, and sustaining software solutions. This enables them to strike a balance between risk management and operational efficiency to enhance their overall performance. 

Disclaimer: Whilst TOPRA is running this webinar for EXTEDO this is not an endorsement of EXTEDO, EXTEDO's affiliates, employees or its products and services. TOPRA is also not responsible for the content or views expressed during the webinar.

How do I register?

Simply log in or create an account and register below.

Pricing

• Members: free
• Non-members: free

Terms and Conditions

By purchasing this webinar, you are agreeing to TOPRA's training terms and conditions.