Drug device combination products

REMOTE AUDITS

New opportunities for GMP/GDP assessment from exceptional circumstances

HIGHLIGHTED COURSE

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.

LANGUAGE: ENGLISH

 

Learning objectives of the course on Remote Audits

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

Program

Times are UTC +1 (Rome time)

9:30

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

10.45

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?

12.00

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

12.30

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

  • Q&A

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

Stefano Scorsini
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.

ENTRY FEE
€ 400 early bird fee, expires on October 11 2022
€ 450 full price
VAT not included. Please inquire for discounts for multiple registrations. Discounts are not cumulative.

TERMS OF PAYMENT
Advance payment is required with respect to the event date by bank transfer to BANCO BPM Spa – Firenze, IBAN IT81P0503402801000000007431, Bic/SWIFT BAPPIT21N25 made payable to Pharma Education Center S.r.l., Via dei Pratoni 16, 50018 Scandicci (FI), VAT number 02173670486, specifying event title along with name and surname of the participant enrolling. Attendance to the event will be allowed upon payment received. Invoice of payment will be issued after the second half of the month after the course. For further information and/or further assistance please contact (+39) 055 7224179 or email: amministrazione@pharmaeducationcenter.it

COURSE/EVENT 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 refound 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.

CANCELLATION TERMS
In order to cancel enrolment to a 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.

HOW TO REGISTER
Please, fill the form on the web site https://www.pharmaeducationcenter.it/

Resta informato sui prossimi corsi e congressi PEC

 

Via Dei Pratoni, 16 – 50018 Scandicci (FI)
Tel. (+39) 055 0465181
E-mail: info@pharmaeducationcenter.it