Auditing Clinical Trials – module 2: in-depth auditing life cycle

  • 2° EDITION: 15 May 2024
  • Online
  • Italian

Training overview

How to manage the audit cycle as a whole? What are the most important aspects to consider?

Audit is a time of confrontation, and to carry it out in the best possible way there are predetermined steps and specific forms that involve multiple clinical research professionals.
The training course “Auditing Clinical Trials – module 2: in-depth auditing cycle” focuses on the audit life cycle and will illustrate all its steps with practical examples. You will learn the appropriate terminology and how to master your skills to make audit a smooth a standardized process and optimize its execution, making it a useful tool for continuous improvement. This training is designed for both those who perform audits and those who receive them, in order to approach the process stepwise and address each step in the best way.

This training is part of a cycle consisting of two modules. The first module is “Auditing Clinical Trials – module 1: an introduction to auditing clinical studies“.

If you buy both modules the price is 1150 €!

Key points of the training

  • Manage audit forms and audit life cycle timelines
  • Optimize the management of the audit process at the different stages
  • Drafting the final audit report
  • Manage the CAPA (Corrective Action and Preventive Action)

09:30 – 12:30 MORNING SESSION
14:00 – 17:00 AFTERNOON SESSION

MORNING

  • The program of an audit: process, preparation and timing
  • Figures involved in the audit and communication
  • Conducting the audit: opening meeting, conducting, questions, conclusion and closing meeting

AFTERNOON

    • The output of the audit: nonconformities, observations, recommendations
    • The management of the final report
    • The management of the CAPA
Settore Ricerca Clinica: Quality Assurance, Monitor/CRA, Clinical Trial Assistant e Project Manager.

The course will be carried out through live lectures. Practical examples will be showcased, providing delegates with real life examples to be applied in their daily job life.

For online trainings the access link will be sent 2-3 days before the start of the training.

5% discount for registrations within 1 month before the start of the training, 10% discount for registrations within 2 months before the start of the training. VAT not included. Please inquire for discounts for multiple registrations. Discounts are not cumulative.

Cancellation terms

In order to cancel enrolment to an event, please email info@pharmaeducationcenter.it within 2 weeks before the starting date of the event. Once this term will be expired, the entire fee will be charged.

Participant replacement

It is possible to replace a participant attendance without additional cost, simply by contacting info@pharmaeducationcenter.it. It is asked to notify the participant replacement request within 5 days before the starting date of the course/event, specifying the full name and surname of the enrolled participant as well as the full name and surname of the substitute.

Training cancellation

If the minimum number of participants is not reached, Pharma Education Center reserves the right to cancel or schedule the event for another date. Formal communication will be given within 5 days before the event date. In this case Pharma Education Center will refund the registration fee in full and without additional charges. Alternatively, the participant can request a spendable coupon for participating in another PEC event scheduled in the current year.

Speakers

Oriella Nasta

Oriella Nasta

Quality Assurance & Auditor - Independent Consultant

Graduated in Industrial Pharmacy in 2008 and operating for over 10 years in the pharmaceutical and cosmetic sector with strong experience in clinical studies and skills for the management of CRO pursuant to DM.15.11.2011. In January 2020 she became an Independent Consultant as QA & Auditor with experience in GxP and ISO in the pharmaceutical, cosmetic and food sectors. Expertise: Quality system management (SOP management, selection of training providers; implementation of audits and CAPA), according to GCP/GMP/ISO; Internal and external quality controls, AIFA audits and inspections; Support to CRA, Project Manager and Medical Director for Clinical Trials according to ICH GCP (E6) R2.

Register now

Early Bird 10%
Within 2 months before the start of the training
720€
800€
Early Bird 5%
Within 1 month before the start of the training
760€
800€
Full price

800€

Training materials available for attendees

Certificate of attendance

Senior trainers with hands-on experience

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