GxP (Good for Practice) Laboratories - Requirements for Performing the Role of QA and GCP Auditor

SECONDA EDIZIONE: 30 GENNAIO - 4 APRILE 2025

End date 30 gennaio 2025

End date 4 aprile 2025

Language:  Italian

Scientific-educational contact: projectdare.education@unibo.it

Administrative contact: info@arithmostech.com

Location:
Department of Statistical Sciences "Paolo Fortunati", Alma Mater Studiorum University of Bologna (Via Belle Arti, 41).

Learning outcomes

Learning outcomes

The course is designed to train qualified professionals in the life sciences sector, with a particular focus on quality management and auditing procedures in regulated environments. Students will gain specific skills in:
  • Introduction to regulated activities and Good Laboratory Practices (GxP) in research and development.
  • Quality Management System (QMS) and associated documentation.
  • Risk management techniques and risk mitigation planning.
  • Conducting and managing audits, including preparation, execution, and reporting phases.
  • Evaluation of computer systems (Computer System Validation) and management of documentation in compliance with current regulations.

Course contents

Course Offer

Arithmos, qualified as a Contract Research Organization (CRO) according to AIFA DM 15.11.2011 and registered on the AIFA Observatory portal since 2017, will launch the practical Advanced Training Course "GxP Laboratories (Good for Practice) - Requirements for Performing the Function of QA and GCP Auditor" in the autumn of 2024.

The course is offered at the proposal of Arithmos Srl in collaboration with the DARE project (research co-funded by the Italian Complementary National Plan PNC-I.1 "Research initiatives for innovative technologies and pathways in the health and welfare sector" D.D. 931 of 06/06/2022, "DARE – DigitAl lifelong pRevEntion" initiative, code PNC0000002, CUP: B53C22006450001).

The two-month course, delivered in Italian, aims to introduce the theoretical aspects necessary for auditing activities on trials or experimental centers.

The course is designed as an initial step in theoretical training to achieve the qualification required by current regulations (DM 15.11.2011) for GCP Auditors.

The idea of a practical course on Good Practices (GxP) arose from the observed shortage of specialized personnel in this potential employment area.

Course contents

The course is structured into educational modules that combine theoretical lessons and practical sessions, including:
  • Module 1: Introduction to regulated activities and the role of QA and Auditor.
  • Module 2:Quality Management System, operating standards, and handling deviations.
  • Module 3:Risk management in GxP, with practical exercises.
  • Module 4:: Conducting audits, types of audits, and practical exercises.
  • Module 5::AIFA regulation and GMP/GCP interface.

Access Requirements

The course is aimed at students enrolled in the final year of the following master's degree programmes:

CLASSE LM09 Master's Degrees in Medical, Veterinary, and Pharmaceutical Biotechnology;

CLASSE LM13 Master's Degrees in Pharmacy and Industrial Pharmacy;

CLASSE LM41 Master's Degrees in Medicine and Surgery;

or recent graduates holding a master's degree in the above-mentioned fields.

Participation Costs

Free for students enrolled in the final year of degree courses related to the classes listed in the access requirements; €150.00 (one hundred and fifty euros) + 22% VAT for recent graduates with a specialist or master's degree in the classes listed in the access requirements.

Available spots

Minimum 10, maximum 20 participants.

My Open Badge

Students who pass the final exam will be awarded an Open Badge "MyOpenBadge."

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