Introduzione

Good Distribution Practices (GDP) encompasses a range of best practices aimed at maintaining the integrity and quality of medical devices during storage, handling, and transportation.

The ultimate goal of GDP is to ensure that medical devices reach the end-users without any compromise in their functionality or safety.

This is crucial for protecting patient health and maintaining public trust in healthcare systems.

Chapter 1: Understanding GDP and Regulatory Framework

  • Welcome and Introduction
  • Overview of GDP for Medical Devices
  • Key principles of GDP
  • Understanding the Medical Device Regulation (MDR) requirements for distribution
  • Identifying and managing risks in distribution
  • Q&A Session

Chapter 2: Implementation, Quality Management, and Best Practices

  • Implementing GDP in the Supply Chain
  • Role of Quality Management Systems in GDP
  • Documentation and record-keeping
  • Audit and self-inspection
  • Best practices in handling recalls and non-conformance
  • Q&A Session
  • Feedback and closing remarks

Quality assurance professionals responsible for ensuring that medical devices meet the necessary quality and safety standards throughout the distribution process.

Professionals who manage regulatory compliance related to the distribution of medical devices within the EU and need to stay updated on current regulations and practices.

Professionals overseeing the logistics and supply chain operations for medical devices, including storage, transportation, and handling.

Warehouse and distribution center managers in charge of storage facilities for medical devices.

Professionals involved in monitoring the safety of medical devices in the post-market phase, who need to understand the distribution process’s impact on device safety and performance.

Individuals studying or researching in fields related to medical device distribution, regulatory affairs, or healthcare management.

Training will be in the form of an interactive workshop. It will include presentations, discussions, and Q&A.

Docente/i
Liliana Teles
Info

Liliana Teles

Quality Assurance & Regulatory Affairs Director – Critical Catalyst
Liliana Teles is a pharmacist holding Masters in Pharmaceutical Sciences and Pharmaceutical Medicine, with more than 10 years of experience in Medical Devices and In Vitro Diagnostics Regulatory Affairs & Quality Assurance. At Critical Catalyst, her work is focused in supporting medical device Manufacturers, Distributors, and Importers in achieving regulatory compliance. Experienced in implementation and audit to Quality Management Systems according to ISO 13485 and Good Distribution Practices of medical devices. Passionate about working with dedicated teams, driving projects related to regulatory compliance in the medtech field and streamlining patients access to medical device technology.

Online Training – 2 modules

Module 1 | 26 June 2024 from 2:00 pm to 05:30 pm CEST
Module 2 | 27 June 2024 from 2:00 pm to 05:30 pm CEST

After the registration, you will receive all details about the connection.

The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.

Early Bird: € 790,00* (until 05 June 2024)

Ordinary: € 990,00*

Freelance – Individual – Academy – Public Administration**: € 500,00*

* for Italian companies: +22% VAT

** Early Bird discount not applicable to Freelance – Academy – Public Administration fee

The fee includes: tuition, organizational office assistance, teaching materials and attendance certificate that will be sent after the training via e-mail.

Registrati
Early bird
Acquistabile fino al 05/06/2024
790,00
Ordinaria
Acquistabile fino al 25/06/2024
990,00
Freelance - Privato - Accademia - Pubblica Amministrazione
Acquistabile fino al 25/06/2024
500,00
Svuota

Ilaria Butta
Ilaria Butta
Events & Training Manager
Versione Stampabile
Cosa saprai fare dopo il corso
Risultato atteso
Understand the key principles of GDP with a thorough understanding of what constitutes GDP in the context of medical devices, including the fundamental principles that guide these practices.
Risultato atteso
Interpret and apply the relevant EU regulations that govern the distribution of medical devices, ensuring compliance.
Risultato atteso
Understand how to implement and maintain an effective Quality Management System (QMS) that aligns with GDP requirements, ensuring continuous quality improvement in the distribution process.

<p><span>Online interactive training on Zoom platform. </span></p>
<p><em>LS Academy will provide the access link to the virtual platform a few days before the training.</em></p>

Online interactive training on Zoom platform. 

LS Academy will provide the access link to the virtual platform a few days before the training.

<p><span>Online interactive training on Zoom platform. </span></p>
<p><em>LS Academy will provide the access link to the virtual platform a few days before the training.</em></p>