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CORSO ONLINE: Audit e Auditor 4.0 in GxP

Approcci innovativi all’Audit e sfide degli Auditor alla luce dei nuovi requisiti e delle nuove tecnologie

Date

20-22-27 e 29 ottobre 2020

Location

Online

Language

Italiano

CORSO ONLINE: Audit e Auditor 4.0 in GxP

Il rapido progresso e la disponibilità delle tecnologie più avanzate nel Life Science hanno portato notevoli vantaggi a tutti gli operatori del settore. Le stesse determinano anche la necessità per gli Auditor, per i Responsabili Qualità e per i Responsabili di Compliance di identificare approcci innovativi e nuove metodologie di lavoro.
L’utilizzo oramai consolidato di sistemi elettronici, quali:

  • Electronic Health Records (EHR)
  • Electronic Data Capture (EDC)
  • Electronic Patient Reported Outcomes (ePRO)
  • Electronic Trial Master File (eTMF)

nonché l’adozione di soluzioni tecnologiche e procedurali innovative, quali:

  • l’hosting dei Data Base da parte dei Vendor
  • il Data Transfer e il Data Migration

impongono agli incaricati dell’assicurazione della qualità e agli Auditor di acquisire nuove tecniche di auditing e di approfondire tutti i requisiti normativi, diventati sempre più complessi e stringenti (come, ad esempio, per la Data Integrity e per il GDPR).

  • Qual è quindi l’impatto sulla programmazione degli Audit?
  • Qual è l’impatto sulla preparazione e conduzione di un Audit?
  • Quali le competenze da acquisire?

L'obiettivo del corso online è quello di trattare e approfondire i nuovi approcci di auditing per aggiornare le competenze degli Auditor e per gli addetti alla qualità.

Durante i moduli di questo corso online verranno affrontati i seguenti argomenti:

  • Nuovi requisiti regolatori e linee-guida
  • Nuove metodologie di auditing
  • Verifiche e approfondimenti nell’ambito degli Audit
  • Sistemi di gestione per la Qualità e per gli Audit (ISO 9001:2015 e ISO 19011:2018)
  • Evoluzione nelle GxP
  • Computer System Validation – Gamp 5
  • Good eClinical Practice – Data Integrity
  • Valutazione del Rischio per la Programmazione e Preparazione degli Audit
  • GDPR
  • Sistemi e Tecnologie: EHR; EDC: ePRO; eTMF; Hosting
  • Auditor 4.0
  • Q&A

Lingua del corso
Il corso si terrà in italiano.
Daniela Marcozzi
Daniela Marcozzi Head, R&D QA - Fidia Farmaceutici

With more than 25 years of experience in the Life Sciences, Daniela is currently the Head of R&D QA in Fidia Farmaceutici SpA, a Pharmaceutical Company with Headquarters in Abano Terme, Padua, Italy.
In her position, she is responsible for ensuring quality and compliance of the GCP and GVP Quality System implemented at Fidia Farmaceutici.
Before joining Fidia, she has been working, as Vice-President Strategic Account Management & Scientific Director, from July 2014 to December 2018, at seQure Life Sciences srl, a niche service provider of Pharmacovigilance, Quality Assurance and Regulatory Compliance Solutions.
Daniela has an extensive experience in leading and managing GxP Quality Systems within the Pharmaceutical Industry having being working in Sigma Tau industrie farmaceutiche riunite S.p.A (now ALFASIGMA SpA) for more than 20 years, with her last Job Position as Head of Corporate R&D Quality Assurance and her main responsibilities for ensuring:

  • Regulatory Compliance
  • Effectiveness of the implemented Quality Management System for Corporate R&D Area including Affiliates
  • Compliance in GVP, GCP, GLP, GMP and Computer System Validation
  • Continuous improvement of the organisation and its processes.

 She is qualified as Responsible for Quality Management System (ISO 9001 standards) and as “Lead Auditor”.
She is also qualified as “GVP Lead Auditor” in compliance with EU GVP Module IV (IV.B.3.1.2).
She performed multiple GxP Audits, Compliance Assessments and successfully completed GxP Inspections carried out by EMA, FDA, AIFA, Italian Ministry of Health and other European National Competent Authorities. She is an active member of:

  • GIQAR (the Italian Group of Quality Assurance in Research) 
  • SIMEF (Società Italiana di Medicina Farmaceutica)
  • AFI (Associazione Farmaceutici Italiani)
  • ISOP (International Society of Pharmacovigilance).

She attended multiple national and international events as speaker, trainer, and chairman.
“La sperimentazione Clinica in Italia” and “Pharmacovigilance Audit Manual” written by Daniela, were published as part of SIMEF (previously SSFA) activity.


Auditor, Quality Assurance, Compliance Manager, Quality Manager.

Esperienza del partecipante 

È necessario aver già acquisito un’esperienza di base nel settore della quality assurance in ambito di ricerca clinica.

Il corso, improntato con didattica interattiva, dà la possibilità di approfondire le varie tematiche attraverso il dibattito e la presentazione di esempi pratici e situazioni reali.

Per aumentare l’interattività del corso e l’approccio pratico, il corso prevede la parteciapzione di un massimo di 10 persone.

Corso Interattivo ONLINE

Corso online in 4 moduli da 3.5 ore ciascuno

Modulo 1 | 20 ottobre 2020 alle 09:30 
Modulo 2 | 22 ottobre 2020 alle 09:30
Modulo 3 | 27 ottobre 2020 alle 09:30
Modulo 4 | 29 ottobre 2020 alle 09:30

Tutti i dettagli utili per il collegamento verranno forniti qualche giorno prima dell'inizio del corso online.

Il corso è a numero chiuso: massimo 10 partecipanti

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€ 1.140,00+ IVA  (entro il 29/09/2020)

Ordinaria€ 1.290,00+ IVA

Freelance - Accademia - Pubbliche Amministrazioni*€ 685,00+ IVA


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

La quota comprende: partecipazione al corso, materiale didattico e attestato di partecipazione che saranno inviati per e-mail post corso.

Register now

Course Price

1290.00 €

Early Bird

Tuesday, September 29, 2020

1140.00 €

Payments accepted

  • Bank Transfer
  • Credit Card
  • PayPal

Other Details

Duration

4 Moduli da 3.5 ore

Course Type

Limited number of participants

You will receive

Attestato di partecipazione

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

  • Acquisire le nuove tecniche di auditing e le competenze per affrontare le nuove sfide nell’ambito della compliance

  • Preparare e condurre gli Audit a Sistemi/Processi in cui si utilizzano nuove tecnologie informatiche, dispositivi ed equipment

  • Verificare integrità dei dati nell’ambito dei sistemi paper-less

Participants' Feedbacks

It is not a frontal lesson but an interactive one

The teacher is very competent

Usefulness of the information acquired

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CORSO ONLINE: Audit e Auditor 4.0 in GxP

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Terms & Conditions

Trainings
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

Conferences
The fee includes: seat at the conference, copy of presentations of Speakers who allow the distribution, informative literature for the day, networking lunch, coffee break, organisational office assistance, certificate of attendance. For further information please contact:  e-mail: events@LSAcademy.com  telephone: +39 (0)35.515684

Webinars
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

Common Terms & Conditions

Terms of payment
Payment should be made online (by credit card) or by bank transfer, at the time of registration (only for Italian companies: + 22% VAT) to EasyB s.r.l by bank transfer or by credit card. Bank transfer payable to:

EasyB S.r.l.
Via Roma, 20 – 24022 Alzano Lombardo (Bergamo)
VAT: IT03633040161
BANCO BPM – Filiale di Carobbio degli Angeli
IBAN: IT81 F 05034 53960 000000003450
SWIFT Code: BAPPIT21AY5

Confirmation of event admission will be given on receipt of payment. Invoice will be sent following receipt of payment. EasyB reserves the right to refuse late registrations or additional registrations above the maximum accepted number of participants or registrations of roles that are not included in the target of the event.

Cancellation
Please note that refunds (50% refund of the registration fee) will only be given if cancellation is received at least four weeks before the event date. Cancellations will only be valid if made in writing. Transfer of registrations (or name changes) are allowed for free and should be made in writing within 7 days prior to the event. EasyB reserves the right to postpone or cancel an event, to change the location of an event or to alter the advertised speakers for an event, to change its performance from residential to webinar/online. EasyB is not responsible for any loss or damage as a result of substitution, alteration, postponement or cancellation of an event due to causes beyond its control including without limitation, acts of God, natural disasters, sabotage, accident, trade of industrial disputes, terrorism, hostilities, epidemics, pandemics, and / or authorities’restrictions (so-called factum principis).

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In accordance with the Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016, we inform you that EasyB S.r.l. (with headquarter in Via Roma 20, Alzano Lombardo, Bergamo, Italy, VAT number IT03633040161), as the data controller, will use your personal data voluntarily provided by you only with the consent and in compliance with the principles dictated by the European Regulations on the protection of personal data for, for the management of participation in the course, for sending the newsletter, and for dissemination purposes. You can read the complete information, including your rights and how to exercise them, following this link.