Aufzeichnung Online Training: Full-day pre-course session Audit Trail Review - Im Auftrag der ECA Academy

Aufzeichnung Online Training: Full-day pre-course session Audit Trail Review - Im Auftrag der ECA Academy

Kosten

ECA-Member: EUR 790,--
Regular Fee: EUR 890,--
EU/GMP Inspectorates: EUR 445,--
APIC Member Discount: EUR 840,--

Alle Preise zzgl. MwSt.

Rückfragen unter:
Tel.: 06221 / 84 44 0 E-Mail: info@concept-heidelberg.de

Sprecher

Bob McDowall, R.D. McDowall Ltd.
Yves Samson, Kereon

Zielsetzung

  • You will learn the current regulatory requirements and regulatory expectations for an audit trail (review)
  • All GMP-relevant data (changes and deletions) should be audit trailed – you will learn how to identify GMP-relevant data
  • Event and audit logs: you will understand the differences between and what the regulators expect
  • How should an audit trail review be performed? You will get familiar with the content and the frequency of an audit trail review

Hintergrund

Audit Trail Reviews are required by international regulations like US 21 CFR Part 11 and EU GMP Guide Annex 11. Clause 9 requests:
“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”.

Regulators focus on the (creation), modification and deletion of (GMP-relevant) data while many IT systems are not able to generate audit trails at all or they are not able to generate audit trails for GMP-relevant data.

Therefore, this Online Training is designed to support you to identify GMP-relevant data and how to perform and document an Audit Trail review as part of a second person Review.

Zielgruppe

This Online Training is designed for managers and staff from health care industries as well for auditors who are responsible for the organisation and execution of audit trail (reviews) in their companies.

Technische Details

Um an einem On-Demand-Training oder Webinar teilzunehmen, benötigen Sie keine Software. Die Aufzeichnungen werden über einen Streaming-Server zur Verfügung gestellt. In der Regel wird die Aufzeichnung im MP4-Format bereitgestellt, das jeder PC (Microsoft Windows, Apple IOS) oder jedes Tablet problemlos darstellen kann.

Zeitplan und Dauer:
Wenn Sie sich für ein On-Demand-Seminar oder -Webinar registrieren, können Sie entscheiden, zu welchem Zeitpunkt Sie sich das Seminar online anschauen möchten. Bei einer 1-Tages-Schulung haben Sie 2 Tage, in denen der Stream zur Verfügung steht (bei einer 2-Tages-Schulung 3 Tage und bei einer 3-Tages-Schulung 4 Tage). Innerhalb dieses Zeitraums können Sie den Stream je nach Bedarf starten und stoppen.

Rechtzeitig vor dem geplanten Termin (Ihrem Wunschtermin) erhalten Sie von uns eine E-Mail mit einem Link zur direkten Teilnahme sowie Ihren Log-in-Daten.

Präsentationen und Zertifikat:
Die Präsentationen werden Ihnen kurz vor dem Online Seminar als PDF-Datei zur Verfügung gestellt. Jede/r Teilnehmer/in erhält im Anschluss an das Seminar ein Teilnahmezertifikat zugesandt.

Programm

Why Is An Audit Trail and Its Review Important? 
  • Part 11 and Annex 11 / Chapter 4 requirements for audit trail
  • Regulatory requirements for audit trail review
  • Guidance documents for audit trail review
  • Do I really need an audit trail?
Audit Trail vs. System Log
  • Audit trail content
  • Log files
  • What and when should I review?
  • Meaningful audit trails for a meaningful review
Case Study / Faciliated Discussion: Which Audit Trail to Review?
Attendees will be presented with an overview of the audit trails within an application and the content of each one .  Which audit trails should be reviewed and when?
 
What are GMP-relevant Data?
Annex 11 requires that audit trails monitor GMP-relevant data – what are GMP-relevant data?

Case Study / Faciliated Discussion: Identifying GMP Relevant Data 
Attendees will be presented with a list of records to identify if they are GMP records and how critical they are to help focus the second person review of audit trail data.Examples from production, laboratory and QA examples of GMP relevant data will be provided

Review of Audit Trail Entries
  • Guidance for frequent is “frequent review” of audit trails
  • Process versus system: avoiding missing data integrity issues when only focussing on a per system review
  • What are we looking for in an audit review?
  • Suspected data integrity violation - What do we need to do?
Case Study / Faciliated Discussion: Reviewing Audit Trail Entries
Attendees will be provided with the output of an audit trail to review and see if any potential issues are identified for further Investigation.
 
Technical Controls to Aid Second Person Review of Audit Trails
  • Technical considerations for audit trail review e.g.
  • Identifying data that has been changed or modified – how the system can help
  • Documenting the audit trail review has occurred
  • Review by exception – how technical controls can help
  • Have you specified and validated these functions?

Aufzeichnung vom  16.03.2021
Dauer der Aufzeichnung: ca. 4 Std 25 Min

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