Discover the course

WEBINAR: From Theory to Practice: Data Integrity

Implementing GxP Data Integrity regulations on everyday practice

Date

5-7-12-14 May 2020

Location

Webinar

Language

Italian

WEBINAR: From Theory to Practice: Data Integrity

Data Integrity is one of the most important requirements within the pharmaceutical and medical devices fields. Indeed, the correct management of information and data recording lay the foundations upon which one can take decisions and assumptions on clinical trials (GCP), product quality (GMP), pharmacovigilance (GVP) and compliance with regulations. The scope of Data Integrity also extends to preclinical and clinical labs, thus to GLP. Regulatory bodies require pharmaceutical companies and medical device manufacturers that all critical data (GxP data) are collected, processed, used and stored in a complete, consistent and accurate manner and that data are available to inspectors during audits. This training course will present an analysis of the main regulations and guidelines on Data Integrity in the GxP context. Furthermore, it aims to describe how to appropriately manage data through practical examples. Participants will be involved in exercises in which they will have to identify the gaps in terms of Data Integrity of a given system, evaluate its associated risks and define appropriate actions for mitigation.

DAY 1

INTRODUCTION AND OVERVIEW

  •  What Data Integrity is and why it is important

LAWS AND CULTURAL APPROACH

  • Regulatory requirements for paper records (GXP Data Integrity)
  • Regulatory requirements for electronic records
  • The human factor in Data Integrity errors


Day 2 (interactive session with practical exercises)

DATA GOVERNANCE: What do I need?

CASE STUDY – Data Integrity assessment on a case study

  • The identification of Data Integrity inconsistencies
  • Gaps evaluation and identification of associated risks
  • Mitigation actions needed to overcome any identified gaps

Review of the outcomes and discussion.


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.

This training course is designed for professionals working within the pharmaceutical and medical devices industry and being involved in information and data management activities.


Interactive training and hands-on sessions

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: € 1.315,00* (until 19 May 2020)

Ordinary: € 1.545,00*

Freelance - Academy - Public Administration: € 715,00*


* 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

795.00 €

Early Bird

Tuesday, April 28, 2020

720.00 €

Payments accepted

  • Bank Transfer
  • Credit Card
  • PayPal

Other Details

Duration

2 days

Course Type

Limited number of participants

You will receive

Certificate of attendance

At the end of the training, you will be able to

  • Identify the main Data Integrity requirements for paper and electronic records according to GxP

  • Know how to use the main international directives and guidelines on Data Integrity

  • Have a hands-on tool to ensure Data Integrity within your working context

Participants' Feedbacks

Practical examples carried out during the lessons

Comparison with problems faced in other working realities

The teacher is very competent

Usefulness of the information acquired

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WEBINAR: From Theory to Practice: Data Integrity

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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

Webinars
The fee includes: tuition, teaching materials, organizational office assistance, attendance certificate. Early Bird discount not applicable to Freelance – Academy – Public Administration fee. For further information please contact:  e-mail: training@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
BANCO BPM – Filiale di Carobbio degli Angeli
IBAN: IT81 F 05034 53960 000000003450
SWIFT Code: BAPPIT21AY5

Confirmation of event admission will be given on receipt of payment. Invoice will be sent following receipt of payment. EasyB reserves the right to refuse late registrations or additional registrations above the maximum accepted number of participants or registrations of roles that are not included in the target of the event.

Cancellation
Please note that refunds (50% refund of the registration fee) will only be given if cancellation is received at least four weeks before the event date. Cancellations will only be valid if made in writing. Transfer of registrations (or name changes) are allowed for free 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, to change its performance from residential to webinar/online. 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, hostilities, epidemics, pandemics, and / or authorities’restrictions (so-called factum principis).

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