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ONLINE TRAINING: Analisi critica e strumenti operativi per affrontare l'Audit Trail Review

Dalla normativa alla pratica

Date

11 and 13 November 2020

Location

Online

Language

Italian

ONLINE TRAINING: Analisi critica e strumenti operativi per affrontare l’Audit Trail Review

 Le Normative GxP richiedono che la creazione, la modifica o la cancellazione di un dato GMP (cartaceo o elettronico) sia tracciabile lungo tutto il suo ciclo di vita.

L’annex 11 “Computerized Systems” della EU GMP Guideline riporta, al capitolo 9, il seguente requisito:

“Consideration should be given, based on a risk assessment, to building into the system the creation of a record of all GMP-relevant changes and deletions (a system generated “audit trail”). For change or deletion of GMP-relevant data the reason should be documented. Audit trails need to be available and convertible to a generally intelligible form and regularly reviewed”

Gli audit trail sono dei metadata che consentono di ricostruire la storia di un dato dalla sua creazione fino alla sua cancellazione, identificando “Who, What, When e Why” (ref. Draft Guidance "Data Integrity Guidance for Industry", April 2016) per ogni step del suo ciclo di vita.

Le normative richiedono che gli audit trail siano rivisti periodicamente al fine di verificare l’integrità dei dati, e di identificare ed investigare eventuali modifiche inappropriate ai dati GXP.

Il corso viene erogato in modalità online in due moduli:

  • Il primo modulo affronta il processo di revisione dei dati, partendo dalle aspettative regolatorie in ambito GxP. Saranno approfonditi i concetti di dati e metadati (e.g. diverse tipologie di. Audit trail) attraverso esempi pratici e la presentazione di alcuni finding da ispezioni regolatorie.

  • Nel secondo modulo sarà invece affrontato il tema della revisione dell’audit trail. Saranno analizzati gli elementi necessari a definire le modalità e la frequenza dell’audit trail review attraverso un approccio risk based. 

MODULO 1

Le review dei dati in ambito GxP: come assicurare l’integrità dei dati.

Definizione di Dati e Metadati

Audit Trail e Audit Trail Review: il contesto normativo

Gli elementi di un audit trail

Controlli tecnici e procedurali per una corretta gestione dell’audit trail

Le diverse tipologie di Audit trail review  


MODULO 2

L’audit trail review: quali dati sottoporre a revisione e con che frequenza.

Audit trial review: l’approccio risk based

Come identificare i dati critici di un sistema 

Identificare e analizzare i controlli sui dati in un sistema (e.g chi inserisce i dati, chi modifica i dati/parametri, etc)

L’importanza della Segregation of Duties per assicurare l’integrità dell’audit trial

La frequenza di revisione dell’audit trail: alcuni esempi



Lingua del webinar

Il corso si terrà in italiano.

Stefano Piccoli
Stefano Piccoli Biomedical engineer

Stefano Piccoli is a biomedical engineer. He founded QStep srl, a services company specialized in Computer System Validation, IT compliance and Data Integrity in the context of GxP. He has more than 20 years experience in the pharmaceutical field (GxP). In particular, in the following areas: Computer System Validation, IT/QA Risk Management, and Quality Assurance. In recent years, he has devoted himself to further study and analysis different aspects of Data Integrity and Information Security. He was granted an Executive Master degree in IT Governance & Management by the LUISS Business School in 2015. He is PMP, ITIL V.3 Transition, CobIT 5, CISM certified. He collaborates with some of the most relevant Italian pharmaceutical companies as consultant for Data Integrity.

Il corso è rivolto a tutti i professionisti che operano in ambito GXP nel settore Lifescience con particolare riferimento a tutto il personale che è coinvolto nella revisione dell’audit trail. (e.g. Laboratori, Produzione, Quality Assurance).

Didattica interattiva con esercitazioni pratiche

Online

Webinar in 2 moduli:

- Modulo 1 | 11 novembre 2020 dalle 10.00 alle 12.30

- Modulo 2 | 13 novembre 2020 dalle 10.00 alle 12.30


La quota comprende

Accesso al corso, materiale didattico in formato pdf fornito post-corso, assistenza segreteria organizzativa, attestato di partecipazione. 


Il corso si svolgerà al raggiungimento di un numero minimo di partecipanti. In caso contrario verrà data comunicazione agli iscritti almeno una settimana prima dalla data del corso.

Certificate of attendance

Early Bird€ 590,00+ IVA  (fino al 28 Ottobre 2020)

Ordinaria€ 665,00+ IVA

Freelance - Accademia - Pubbliche Amministrazioni€ 485,00*+ IVA


* Lo sconto Early Bird non si applica alla quota per Freelance - Accademie - P.A.

La quota comprende: Accesso al webinar, materiale didattico in formato pdf fornito post-webinar, assistenza segreteria organizzativa, attestato di partecipazione. 

Register now

Course Price

665.00 €

Early Bird

Wednesday, October 28, 2020

590.00 €

Payments accepted

  • Bank Transfer
  • Credit Card
  • PayPal

Other Details

Duration

2 modules (2,5 hours each)

Course Type

Limited number of participants

You will receive

Certificate of attendance

At the end of the training, you will be able to

  • Identificare quali sono i dati GxP per cui è richiesto un audit trail

  • Determinare la tipologia di audit trail review da applicare

  • Comprendere ruoli e resposabilità nel processo di audit trail review

  • Sapere come documentare una review

Participants' Feedbacks

Lecturers know what they are talking about and are able to answer the questions. It's clear that they work and have experience in the field

no standard workshop which is very stressful so the way that this course was conducted was excellent and the first one for me were I was so relaxed… thank you for that feeling!

Topics which are not included in other educations I've been on (orphans, ATMP and similar)

Exemples from real life situations from the workplace were very useful.

International and multidisciplinary profile of participants, which enriches the training

Excellent interaction between teachers and participants

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ONLINE TRAINING: Analisi critica e strumenti operativi per affrontare l’Audit Trail Review

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The fee includes: tuition, teaching materials, lunches and coffee breaks, organizational office assistance, attendance certificate. Early Bird discount not applicable to Freelance – Academy – Public Administration fee.
The course will proceed with a minimum of 8 participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
For further information please contact:  e-mail: training@LSAcademy.com  telephone: +39 (0)35.515684

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The fee includes: tuition, teaching materials, organizational office assistance, attendance certificate. Early Bird discount not applicable to Freelance – Academy – Public Administration fee. For further information please contact:  e-mail: training@LSAcademy.com  telephone: +39 (0)35.515684

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