Remote Audits

Training overview

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.

Key points of the training

  • 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
Structure of the course

09:30 – 12:30 COURSE SESSION

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

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

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.

Register now

Early Bird 10%
Within 2 months before the start of the training
400€
450€
Early Bird 5%
Within 1 month before the start of the training
425€
450€
Full price

450€

Training materials available for attendees

Certificate of attendance

Senior trainers with hands-on experience

You may also be interested in...

Richiedi informazioni

Ask for information