Introduzione
Good Distribution Practices (GDP) ensure that medicinal products and medical devices are consistently stored, transported, and handled to maintain their quality and integrity.
They minimize the risk of contamination, mix-ups, and damage, ensuring patient safety.
As the pharmaceutical and medical device industries operate in an increasingly complex and globalized environment, understanding and implementing GDP is crucial for protecting patient health, maintaining public trust in healthcare systems and ensuring compliance with EU regulations. Additionally, it fosters trust in the supply chain, ensuring that products reach healthcare providers and patients as intended.
This training is designed to provide comprehensive insights into the regulatory framework and operational standards that ensure the quality, integrity, and safety of medicinal products and medical devices from the point of manufacture to the end user.
Understanding GDP and Regulatory Framework
- Welcome and Introduction
- Overview and key principles of EU GDP for medicinal products and medical devices
- Understanding regulatory requirements for distribution (GDP and MDR)
- Identifying and managing risks in distribution
- Q&A Session
Implementation, Quality Management, and Best Practices
- Implementing GDP in the Supply Chain
- Role of Quality Management Systems in GDP
- GDP Certification
- 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 medicines and medical devices meet the necessary quality and safety standards throughout the distribution process.
- Professionals who manage regulatory compliance related to distribution within the EU and need to stay updated on current regulations and practices.
- Professionals overseeing the logistics and supply chain operations for medicines and medical devices, including storage, transportation, and handling.
- Warehouse and distribution center managers in charge of storage facilities.
- Professionals involved in monitoring the safety of medicines and medical devices in the post-market phase, who need to understand the distribution process’s impact on product’s integrity.
- Individuals studying or researching in fields related to health product’s distribution, regulatory affairs, or healthcare management.
The training is highly interactive. It will include presentations, discussions, and Q&A.
Docente/i
Liliana Teles
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 | 11 June 2025 from 2:00 pm to 5:30 pm CEST
Module 2 | 12 June 2025 from 2:00 pm to 5:30 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 21 May 2025)
Ordinary: € 990,00*
Freelance – Individual – Academy – Public Administration**: € 565,00*
* for Italian companies: +22% VAT
** Early Bird discount not applicable to Freelance – Individual – 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.
Cosa saprai fare dopo il corso
Online interactive training on Zoom platform.
LS Academy will provide the access link to the virtual platform a few days before the training.
