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Webinar: Unlocking Strategic Value in Drug Safety for Life Sciences Organizations

This webinar focuses on transforming security teams from reactive cost centers to proactive benefit drivers by highlighting the significance of equipping them with the necessary tools & resources for actionable insight and the key elements for life sciences organizations.
Vigilance

ATMP Supply Chain: Navigating the Challenges and Exploring the Vein-to-Vein Strategy

Through real-life examples and visuals, we will explore the roadmap to navigate the ATMP supply chain and unlock its full potential. Don't miss this opportunity to be at the forefront of the next-generation healthcare revolution!
ATMP

Setting up ATMP Quality Management Systems: Strategies for Compliance and Success

Discover how to prepare effectively a Compliant ATMP Quality Management System and the key elements required to establish and maintain a QMS that adheres to Eudralex Part IV regulations.
ATMP

Verification & Validation of Artificial Intelligence/ Machine Learning Medical Devices

IEC62304 and IEC 82304 detail the different aspects related to product realization as per ISO 13485, especially for the verification and validation activities. But what to do with Medical Devices when it comes to Artificial Intelligence or Machine Learning?
MD

Medical Devices Risk Management according to ISO 14971:2019

During this webinar, the process of risk management according to ISO 14971:2019 is explained, highlighting the changes compared to the old version of the standard.
MD

Is virtual manufacturing still possible under the IVDR?

This presentation will explore whether this practice will still be possible under the IVDR and how to best manage the relationship between the legal manufacturer and the contract manufacturer.
IVD

Clinical Evaluations and Clinical Investigations for Medical Devices under MDR

Are you involved in the development or evaluation of medical devices? Do you want to enhance your understanding of the Clinical Evaluation and Clinical Investigation processes?
MD

The Medical Device CE Certification Pathway Explained: From Classification to Conformity Assessment by the Notified Body

Are you submitting a Medical Device under MDR? In this webinar, you will learn more about the main points to consider.
RA

Post-Market Surveillance requirements for Medical Devices and IVDs

Learn about the regulatory requirements for post-market surveillance (PMS) under the European Medical Device Regulations 2017/745 (MDR) and In Vitro Diagnostic medical device Regulations 2017/746 (IVDR).
RA

Building Safe and Effective Medical Devices: A Deep Dive into the Design and Development Process

During this webinar, the process of Design and Development of Medical Devices according to ISO 13485 and applicable regulations will be explained, with practical yet simplified examples to illustrate the main concepts of the process. How to handle changes to Medical Devices will also be explained.
MD

Computer System Validation Courses

Stay on top of new trends and refresh your knowledge with the help of our CSV experts. Follow our FREE online CSV program.
CSV

Medical devices: urgent needs vs regulation

Learn about early verification in a stringent design control process to decrease Time to Market and master the full product lifecycle of medical devices, not the least in pandemics like COVID-19.​​​​​​​ ​​​​​​​
MD

The basic concepts of the QbD methodology

Learn about the basic concepts of the QbD methodology and the main struggles of process optimization. Get an exclusive demonstration of the Scilife Quality by Design solution.
ATMP

Intro to Cell and Gene therapy

In this webinar, you will learn more about the typical cell and gene therapy workflow process with a focus on manufacturing.
ATMP

3D Printing in the Healthcare world

Learn about Medical Equipment manufacturing while meeting regulations, discover tips and tricks to efficiently 3D print and find out about the most common pitfalls you need to avoid when designing and producing Medical Equipment.
MD

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Come visit our booth at CPHI Barcelona 2023

Come to see the QbD Group at stand #3G73 at CPHI Conference in Barcelona. And after the conference…Eat & Connect with lifescience professionals at our QbD’s CPHI Networking Drink.