Remote Audits

  • 2° EDIZIONE: 21 Maggio 2024
  • Online
  • Inglese

Contenuto del corso

New opportunities for GMP/GDP assessment from exceptional circumstances

The Covid 19 pandemic has prompted companies to review approaches and ways of working; one of the aspects touched upon is an alternative approach on audits management which has a potentiality to be used even in the routine basis as equivalent to the established methodology (on-site audit).
The course “Remote Audits” aims to improve the knowledge of remote auditing technique with evaluation of relevant pros and cons vs. on-site one, presenting challenges but mostly good opportunities of a possible use of a combination of the two modalities for GMP/GDP qualification and routine audits.
The delegate will become more familiar with efforts to be put and tools to be used in every process step of remote GMP/GDP auditing process, with the objective of achieving a complete and effective overview getting the expected interchange with on-site ones.
He will get additional awareness on the meaningful importance of a risk-based approach both for auditing process preliminary planning stages as well as for decisions on reauditing timelines.
The course “Remote Audits” will provide also additional guidance and applicable suggestions, based on experienced situations presented as unreferenced case studies.

Cosa saprai fare dopo il corso?

  • To understand similarities and differences between remote and on-site auditing techniques and assess applicability criteria of the former
  • To underline the importance of risk-based planning and feasibility evaluation steps
  • To review methodology to get an effective audit planning step
  • To identify key moment during audit conduct
  • To achieve familiarity with audit closing meeting: communication of exit notes and/or audit findings
Struttura del corso

09:30 – 12:30 SESSIONE CORSO


Times are UTC +1 (Rome time)


Overview of guidance documents

  • Definition and scope
  • Actual and potential future applicability

Peculiarities of remote audit

  • Communication
  • Systems access
  • Documents sharing
  • Document review
  • GMP operations overview

Remote audit vs. on-site audit

  • Plant tour
  • Communication and inter-personal relation
  • Time management


Remote Audit Step 1: audit planning and feasibility

  • Audit plan:
  • Priorities
  • Risk/criticality assessment
  • Early contact with Auditee
  • Feasibility questionnaire and “negotiation of practical items”

Remote Audit Step 2: audit agenda

  • Audit announcement
  • Resources requirements
  • Inclusion of practical items and potential challenges in agenda
  • Who’s in charge of practical items?


Remote Audit Step 3: conducting remote audit

  • Opening meeting
  • Audit execution
  • Wrap-up meeting
  • Closing meeting

Remote Audit Step 4: audit report

  • GMP/GDP non-compliance: Findings rating and classification
  • Audit report conclusions


Workshop – Final session
Discussion on case studies presented during previous sessions


This Training Course is of particular interest for:

  • Quality Unit Specialists and Managers
  • Qualified Persons and any other cross-functional Team Member (e.g. Manufacturing, Engineering, Purchasing Departments) dealing with first level (self-inspection)
  • API Manufacturers, Vendor and Outsourced GMP-Services Providers audits

Il corso si sviluppa attraverso lezioni frontali. Grazie ad una metodologia didattica interattiva con presentazione ed esempi pratici, i partecipanti potranno avere spunti da poter applicare nella loro realtà professionale.

Se il corso è online, il link di partecipazione verrà inviato 2-3 giorni prima dell’inizio del corso.

Sconto del 5% per le iscrizioni entro 1 mese dal corso, sconto del 10% per le iscrizioni entro 2 mesi dal corso. I prezzi sono da intendersi IVA esclusa. Le offerte non sono cumulabili. Per sconti su iscrizioni multiple rivolgersi a

Modalità di cancellazione

Si richiede di comunicare la disdetta all’evento formativo inviando un’e-mail a entro due settimane dalla data di inizio dello stesso. Trascorso tale termine, si procederà con l’addebito dell’intera quota.

Modalità di sostituzione partecipante

Si prevede la possibilità di cambiare il nome del partecipante all’evento formativo, senza alcun costo aggiuntivo, inviando un’e-mail a: Si chiede di dare comunicazione entro una settimana dalla data di inizio dello stesso indicando il nome del primo iscritto e il nome del sostituto.

Condizioni di annullamento o rinvio

Pharma Education Center si riserva la facoltà di annullare o posticipare l’evento formativo nel caso in cui non si raggiunga un numero minimo di partecipanti. Pharma Education Center si impegna a restituire la quota d’iscrizione già versata senza ulteriori oneri o su richiesta dell’iscritto concedere un bonus spendibile per la partecipazione ad un altro evento formativo in programma nell’anno corrente.


Stefano Scorsini

Stefano Scorsini

Quality & Process Manager at Pharma D&S
Solid experience with more than 30 years in GMP Pharmaceutical Operations covering different roles (Head of Manufacturing Departments, Production Manager, Manufacturing site Director), completed by the fact of being appointed first Italian Technical Director (1992-2000) and then EU and MHRA Qualified Person in different Pharmaceutical Companies. Dr  Scorsini had consolidated a remarkable experience in different areas as : Management of Quality System elements with associated routine tasks (Changes, Complaints, Deviations / Investigations, Risk assessment, APQRs), GMP/GDP auditing processes (Lead Auditor since 2014), entire flow of GMP pharmaceutical operations, project management of technology transfers, management of selection, installations and qualification – validation of production equipment and associated utilities, URS definition and start-up of ERP systems.

Iscriviti al corso

Early Bird 10%
Valido fino a 2 mesi dal corso
Early Bird 5%
Valido fino a 1 mese dal corso
Full price


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