Dr Bob McDowall
R.D. McDowall Ltd.
Referierende
Yves Samson
Kereon
Attendees will get a free electronic copy of ECA “GMP Data Governance and Data Integrity Guide – Version 3”.
We offer you a discount of EUR 600 if you book this training course together with the course "Data Integrity - Requirements for a GMP-compliant Data Life Cycle" from 28-30 October 2026.
Zielgruppe
These Live Online Trainings are designed for
- managers and staff from health care industries
- managers and staff from suppliers
- auditors who are responsible for the organisation and execution of Audit Trail (Reviews) and Data Integrity in their companies.
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
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?
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
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.
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?
Weitere Informationen
Technical Information
We use Webex for our live online training courses and webinars. At www.gmp-compliance.org/training/online-training-technical-information you will find all the information you Need to participate in our events and you can check if your System meets the necessary requirements to participate. If the Installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.
Fees (per delegate, plus VAT)
Non-ECA Members EUR 1,290
ECA Members EUR 1,090
APIC Members EUR 1,190
(does not include ECA Membership)
EU GMP Inspectorates EUR 645
The conference fee is payable in advance after receipt of invoice.
We offer you a discount of € 600 if you book this training course together with the course "Data Integrity - Requirements for a GMP-compliant Data Life Cycle " from 28-30 October 2026 here.
ECA Members EUR 1,090
APIC Members EUR 1,190
(does not include ECA Membership)
EU GMP Inspectorates EUR 645
The conference fee is payable in advance after receipt of invoice.
We offer you a discount of € 600 if you book this training course together with the course "Data Integrity - Requirements for a GMP-compliant Data Life Cycle " from 28-30 October 2026 here.
Presentations/Certificate
The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Conference language
The official conference language will be English.
The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Conference language
The official conference language will be English.
Contacts
Questions regarding content:
Dr Andreas Mangel (Operations Director), +49 6221 84 44-41, mangel@concept-heidelberg.de
Questions regarding Organisation:
Mr Rouwen Schopka (Organisation Manager), +49 6221 84 44-13, schopka@concept-heidelberg.de
Datum & Uhrzeiten
Tue, 27 October 2026, 09:00-17:15 h
All times mentioned are CET.
Teilnahmegebühr
| ECA-Member*: | € 1090,- |
| Regular Fee*: | € 1290,- |
| EU/GMP Inspectorates*: | € 645,- |
| APIC Member Discount*: | € 1190,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Weitere Termine vor Ort
Weitere Termine vor Ort nicht verfügbar
Weitere Termine online
Weitere Termine online nicht verfügbar
This course is part of the GMP Certification Programme "ECA Certified Data Integrity Manager"
Haben Sie noch Fragen?
Wir stehen Ihnen für weitere Auskünfte gerne zur Verfügung.
E-Mail: info@concept-heidelberg.de
Teilnehmerstimmen
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