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WEBINAR: 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.
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.
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
ALCOA Principles and guidance
· ALCOA for Paper and Electronic Records
· Example of each ALCOA attributes
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
· Elements of Data Governance Framework
· Human Factors in Data Integrity
· Data Integrity Maturity Model
The course will be in English.If all participants are Italian, the course will be held in Italian.
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.
· 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 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.
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.
Sunday, May 19, 2019
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