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Webinar: Audit Trail Review
From regulations to practice
GMP Regulations require that the creation, change or deletion of GMP data (in paper or in an electronic format) need to be traceable throughout its life cycle. Annex 11, "Computerized Systems", of the EU GMP Guideline specifies, in chapter 9, the following requirement: “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”. Audit trails are metadata that allow us to reconstruct the history of a piece of data from its creation until its deletion, identifying "Who, What, When and Why" (ref. Draft Guidance "Data Integrity Guidance for Industry", April 2016) for every step of its life cycle. The regulations require that the audit trails are periodically reviewed in order to check the integrity of data, and to identify and investigate any inappropriate changes to GMP data. This Workshop aims to help participants in carrying out an audit trail review by discussing case studies during the session.
A. Audit and Audit Trail Review: what do regulations ask for?
1. Definitions and regulatory requirements
- FDA 21 CFR part 11, Eudralex annex11/chapter 4
2. What do guidelines say?
Each session will be backed with practical examples
B. Audit Trail Review: where do I start?
- Business Process vs Data
- How to identify the critical (GMP relevant) data of a system?
C. Identify the different types of audit trail in a system
- Audit trail
- Log file
- Legacy system without electronic audit trail: how to do it?
D. Determine the frequency with which an audit trail review is needed
- What are the elements that define the frequency with which an audit trail review is needed
E. Who are the actors of the process of an Audit Trail Review and what are their responsibilities
- Business process Owner
- Quality Assurance
- System Owner (e.g. IT, Engineering)
F. How to do an audit trail review
- Which elements you need to consider during the review?
- How to document the outcome of the review?
Stefano Piccoli is a biomedical engineer. He founded QStep srl, a services company specialized in Computer System Validation, IT compliance and Data Integrity in the context of GxP. He has more than 20 years experience in the pharmaceutical field (GxP). In particular, in the following areas: Computer System Validation, IT/QA Risk Management, and Quality Assurance. In recent years, he has devoted himself to further study and analysis different aspects of Data Integrity and Information Security. He was granted an Executive Master degree in IT Governance & Management by the LUISS Business School in 2015. He is PMP, ITIL V.3 Transition, CobIT 5, CISM certified. He collaborates with some of the most relevant Italian pharmaceutical companies as consultant for Data Integrity.
The course is designed for all professionals working in the GMP field within life sciences, with particular interest for those involved in the audit trail review (e.g. labs, production, quality assurance).
This Webinar in divided in 2 modules:
- Module 1 | 23 June 2020 from 2.00 pm to 3.30 pm
- Module 2 | 30 June 2020 from 2.00 pm to 3.30 pm
The fee includes
Access to the webinar, teaching materials in pdf format provided post-webinar, organizational office support, certificate of attendance.
The course will proceed with a minimum number of participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
Early Bird: € 360,00* (until 2 June 2020)
Ordinary: € 435,00*
Freelance - Academy - Public Administration: € 216,00*
* for Italian companies: +22% VAT
** Early Bird discount not applicable to Freelance - Academy - Public Administration fee
The fee includes: Access to the webinar, teaching materials in pdf format provided post-webinar, organizational office support, certificate of attendance.
Tuesday, June 2, 2020
At the end of the training, you will be able to
Identify which are the GMP date for which an audit trail is needed
Know the steps in an audit trail review process
Know how to document an audit trail review