WE BELIEVE IN CONTINUOUS IMPROVEMENT

S4BT Training

In a constantly evolving market, it is essential for companies to prepare continuous training plans aimed at increasing their competitiveness in their target market.

Targeted training allows you to keep up with the ongoing changes and to constantly align your skills and those of your collaborators with emerging needs.

S4BT believes in continuous training and organises courses and workshops for professionals and companies, directly at its headquarters, online or at the company’s headquarters.

Tailored courses

Training for companies

S4BT organises tailored courses for companies, using the best professionals as teachers and with cutting-edge learning tools.

Courses can be held directly at the company or online. In recent years, we have trained hundreds of professionals on GMP, Data Integrity, CSV, Quality Assurance and Validation.

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Professional teachers

Workshops and Webinars

We organise workshops, webinars and events both in the Latina office and across the country to update professionals from different sectors.

We spread our knowledge and extensive consultancy experience by creating opportunities for interaction and networking .

Formazione aziende s4bt
training for young talents

Talent Academy

Since 2017, S4BT has been developing both theoretical and practical training courses in the field for the professional growth of young talents in the field of Life Science consulting and software programming.

Participants in the Talent Academy are supervised directly by our consultants or developers, who bring technical knowledge and practical experience gained over the years to the classroom.

Subsequently, young talents apply knowledge acquired directly in the field while being supervised and supported by our professionals.

Our goal is to train future S4BT consultants and programmers
starting by sharing our knowledge and experience.

participant testimonies

What our clients say

Benefit of participation 92%
Expectations met 90%
Prepared teachers 95%
Content quality 94%

“Topics covered with the utmost clarity. Great expertise”

[Data Integrity Culture 5th Edition]

The lecturer was highly skilled. Congratulations.

[Advanced Data Integrity]

Very clear and comprehensive presentation.
[Managing Deviations in Life Science companies]

Congratulations to the lecturer for their ability to make theoretical and complex concepts simple and immediate.

[PAT & Chemometrics]

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S4BT training

Main objective of the course

  • Provide an in-depth analysis on the critical aspects of the Regulations and Reference Guidelines in Data Integrity
  • Transfer practical elements for assessing the integrity of managed data in GxP production companies

Main topics covered

  • Reference standards and guidelines: WHO, MHRA, EU/US regulations
  • Data classification and integrity attributes
  • Data Integrity Assessment – Case Studies
  • Data Integrity Action Plan

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Agenda

  • Evolution of the CSV
  • Limits set by the CSV
  • A new approach: Computer Software Assurance (CSA)
  • Examples of application of the CSA
  • CS compliance
  • Reference regulations and guidelines
  • Deficiencies during inspections: Annex 11, Part 11 and Data Integrity
  • What awaits us in the future… Computer Software Assurance

From the print-based process to management with a digital system. Case studies, tips and tools to optimise the process.

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The Talent Academy is a 6-month paid classroom and field training programme for the professional development of young talents.

The critical phases of projects related to serialised production with a focus on data integrity for the Medical Device sector.

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NIR spectroscopy for the assessment of material traceability: the case of a continuous pharmaceutical production line.

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The workshop illustrated very effective methods of analysis, control and prevention of data manipulation. The theoretical content will be supported by practical examples, such as risk analysis applications, data mapping, maintenance techniques and periodic audits.

It will also describe the most modern IT systems to raise the overall level of security and integrity for your corporate data.

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CLIENTS
Courses and training

Get in touch to find out more

Fill out the form and tell us your needs – one of our consultants will contact you as soon as possible.

COMPLAINTS

An aid to inspection work

Simplify the management of Complaints, from filing, through investigation, follow-up, judgment and final report.

The module is designed to provide step by step Quality Assurance support
in the implementation and supervision of the process and the assignment of tasks to the departments involved. The module supplements the CAPA procedure, which the user can open directly from the Complaints procedure.

PRAGMA-WFM documents and traces all activities and information in the Complaints process. In each phase, you can also attach files in various formats to support activities and investigations.

During inspection phases, the functionality dossier enables the real-time generation of a document that provides information and lists the activities of the process and related processes

AUDIT

Documents and traces activities

It simplifies the management of internal and external audits, from planning, through execution, to the management of remarks.

The module supplements procedures for handling CAPAs , Non Conformitiesand Change Control that the user can open directly from the audit to resolve the observations found.

PRAGMA-WFM documents and traces all activities and information of the Audit process. For each process step, it is possible to assign tasks to the people involved, and attach files in various formats.

Duringthe inspection phase, the dossierfunctioncan generate a document in real time which records the information and activities of the Audits and related processes