Discover the course

Audit Trail Review - Workshop

From regulations to practice

Date

16 June 2020

Location

Milan

Language

Italian

Audit Trail Review – Workshop

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 Draft Guidance "Data Integrity Guidance for Industry", April 2016) for every step of its life cycle.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.

Theory

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?

Practice

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?

Course Language
The course will be in Italian.
Stefano Piccoli
Stefano Piccoli Biomedical engineer

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).


Interactive training with practical examples

Hotel Melià
Via Masaccio 19
20149 – Milano

Melia Milano is perfectly located in the most dynamic and fastest-growing district in Milan, a short walk from CityLife, a new architectural project with a shopping centre and urban garden. The historical city centre of Milan is just 15 minutes away using the nearby subway.

  2 minutes walking from the metro station Lotto (M1 red line or M5 violet line)

  Milan Linate airport, 12 km from Hotel Melià, is the most closest airport to the city and can be easily reached by car, bus or train

  Central Station 6 km, Cadorna Station 3,5 km, Garibaldi Station 4 km

  Garage Masaccio (30 mt), Garage Lotto (350 mt), Parcheggio San Siro (300 mt)

  In addition to the hotel venue here is some recommended hotels for accommodation in the nearby:

            Hotel Oro Blu (at 230 mt)

            Hotel Portello (at 450 mt)

            Hotel Montebianco (at 270 mt)

  Ristorante Pizzeria La Primula, Via Spagnoletto, 19 (11 minutes by walking). Or, in 15 minutes by metro you can reach the historic city center (“Duomo” metro stop) with various restaurants.


Upon Arrival
At your arrival you will find our Staff at the Welcome Desk to greet and make you feel welcome and as comfortable as possible, providing direction and all information about the meeting, seating, refreshments.

Refreshments
Coffee breaks and lunch will provide a pleasant moment of refreshment. Special care about the food quality, in particular to your dietary needs or preferences, from menus of local products and flavors to vegetarian dishes.

Limited number of participants to encourage networking and discussion.



Training Room

All our training facilities are safe, healthy, comfortable, aesthetically-pleasing, and accessible. They are able to accommodate the specific space and equipment needs of the training program.
Depending on the seating configuration, the room may accommodate lecture-style instruction or encourage interaction in the form of roundtable discussions. Equipped for audio/visual, Free Wi-Fi to allow everyone to connect with just one click, electric sockets.



Teaching materials

All the information necessary for learning during the course is provided. It is recommended to bring your PC to take notes (even directly on the slides provided in PDF format). The environment is important to us and that's why we try to make this meeting an experience of environmental sustainability.

Fee includes
Tuition, teaching materials, lunch and coffee breaks, organizational office assistance, attendance certificate. 

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.

Brochure
Certificate of attendance

Early Bird: € 790,00* (until 26 May 2020)

Ordinary: € 905,00*

Freelance - Academy - Public Administration: € 485,00*


* for Italian companies: +22% VAT

** Early Bird discount not applicable to Freelance - Academy - Public Administration fee


The fee includes: tuitions, teaching materials, lunches and coffee breaks, organizational office assistance, attendance certificate.

Register now

Course Price

905.00 €

Early Bird

Tuesday, May 26, 2020

790.00 €

Payments accepted

  • Bank Transfer
  • Credit Card
  • PayPal

Other Details

Duration

1 day

Course Type

Limited number of partecipants

You will receive

Certificate of attendance

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

Participants' Feedbacks

In each topic there was some relevance to my daily work

Good atmosphere in the group and interaction with the lecturers (really available for all questions)

Perfect organisation, great speakers, relevant topics

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Audit Trail Review – Workshop

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Terms & Conditions

Trainings
The fee includes: tuition, teaching materials, lunches and coffee breaks, organizational office assistance, attendance certificate. Early Bird discount not applicable to Freelance – Academy – Public Administration fee.
The course will proceed with a minimum of 8 participants. Should this number not be reached the registered participants will be notified one week prior to the commencement of the course.
For further information please contact:  e-mail: training@LSAcademy.com  telephone: +39 (0)35.515684

Conferences
The fee includes: seat at the conference, copy of presentations of Speakers who allow the distribution, informative literature for the day, networking lunch, coffee break, organisational office assistance, certificate of attendance. For further information please contact:  e-mail: events@LSAcademy.com  telephone: +39 (0)35.515684

Common Terms & Conditions

Terms of payment
Payment should be made online (by credit card) or by bank transfer, at the time of registration (only for Italian companies: + 22% VAT) to EasyB s.r.l by bank transfer or by credit card. Bank transfer payable to:

EasyB S.r.l.
Via Roma, 20 – 24022 Alzano Lombardo (Bergamo)
VAT: IT03633040161
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Please note that refunds (70% refund of the registration fee) will only be given if cancellation is received at least one week before the event date. Cancellations will only be valid if made in writing. Transfer of registrations (or name changes) are allowed and should be made in writing within 7 days prior to the event. EasyB reserves the right to postpone or cancel an event, to change the location of an event or to alter the advertised speakers for an event. EasyB is not responsible for any loss or damage as a result of substitution, alteration, postponement or cancellation of an event due to causes beyond its control including without limitation, acts of God, natural disasters, sabotage, accident, trade of industrial disputes, terrorism, or hostilities.

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