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WEBINAR: From Theory to Practice: Data Integrity

Implementing GxP Data Integrity regulations on everyday practice

Date

09, 11, 16 e 18 June - starting time 2.30 pm CEST

Location

Webinar

Language

English

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.

The focus of this 4 modules webinar is:

·         to present an analysis of the main regulations and guidelines on Data Integrity in the GxP context

·         to deepen the ALCOA characteristics through practical examples to understand the elements that contribute to determining the quality of a data, whether it is a paper or electronic record

·         to provide some good practices for conducting a data integrity assessment on computer systems by identifying the approach to be followed and the tools to be used

·         to provide an overview of Data Governance, its elements and the importance of the human factor in data management.

MODULE 1

Data Integrity & Regulatory Requirements

·         What data Integrity means?

·         Data Integrity & Technology Trend

·         Data Integrity Regulations and Guidance: the Landscape

·         21 Cfr part 11 & Annex 11 in a nat shell

·       Regulatory Findings on Data Integrity 


MODULE 2

 ALCOA Principles and guidance

·       ALCOA for Paper and Electronic Records

·       Example of each ALCOA attributes

·       Q&A


MODULE 3

Data Integrity Assessment:

·       How to plan and set up a DI assessment on existing Computerized systems

·       Tools and techniques to conduct a comprehensive DI assessment

·       Examples of gaps and mitigation controls (technical and procedural controls)

·       Case study

·       Q&A


MODULE 4

Data Governance

·       Overview

·       Elements of Data Governance Framework

·       Human Factors in Data Integrity

·       Data Integrity Maturity Model



Course Language

The course will be in English.

If all participants are Italian, the course will be held 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.


AGENDA

·         2:30 pm introduction

·         2:35 lecture

·         3:30 breack

·         3:40 case study presentation and discussion or lecture,

·         4:00 pm Q&A
4:30 end of session. 



Training, case studies discussion and Q&A sessions



Webinar

Webinar online - 4 modules): 

09 June 2020 at 2.30 pm CEST

11 June 2020 at 2.30 pm CEST

16 June 2020 at 2.30 pm CEST

18 June 2020 at 2.30 pm CEST


After the registration, you will receive all details about the connection. 


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.

Certificate of attendance

Early Bird: € 720,00* (until 19 May 2020)

Ordinary: € 795,00*

Freelance - Academy - Public Administration: € 360,00*


* for Italian companies: +22% VAT

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


The fee includes: tuition, teaching materials and attendance certificate that will be sent after the training via e-mail.

Register now

Course Price

795.00 €

Early Bird

Sunday, May 19, 2019

720.00 €

Payments accepted

  • Bank Transfer
  • Credit Card
  • PayPal

Other Details

Duration

4 modules - 2 hours

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

The venue is very beautiful and LS Academy staff was efficient

It is not a frontal lesson but an interactive one

Detailed analysis of operating methods

The teacher is very competent

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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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