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From Theory to Practice: Data Integrity
Implementing GxP Data Integrity regulations on everyday practice
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.
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 and paper 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.
The course will be in English.
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.
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.
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.
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.
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.
Early Bird: € 1.570,00* (until 29 August 2020)
Ordinary: € 1.780,00*
Freelance - Academy - Public Administration: € 890,00*
* 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.
Saturday, August 29, 2020
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