Fondazione DARE

Professionalising courses

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

AUTUMN 2024

Start date 11 October 2024

End date 6 December 2024

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).

DEADLINE

Application deadline
Sunday, October 6, 2024, 13:00

Open Day

September 13, 2024, 16:00

Arithmos and the DARE Foundation will host an online open day to present the course. To participate, simply join via Teams at the following link: 

Click here to join the meeting

Meeting ID: 332 039 463 877

Passcode: vyYygi

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."

Click here to download the official call for applications in PDF format.

Course enrollment

To enroll in the course, please fill out the form on the Arithmos website.
Enrollment in the course will be formalized and confirmed for the first 20 participants through a confirmation email from Arithmos. This email will be sent after the application deadline to the address indicated in the pre-registration form.
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