Consulting, Compliance and Validation

SPAI

Machines and workplace accidents

Deaths in the workplace were the subject of an episode of the Italian TV programme Report, which aired on channel Rai 3 on 9 May. While the European average is 2.2 deaths per 100,000 employees, Italy stands at 2.7, which is much[…]

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Fabio Farneti at COMtecnica events

A two-day, content-rich and professionally stimulating event with networking opportunities. COMtecnica Conference 2022, which was held a few days ago at the Ca’ Foscari University of Venice, was all that and more. Our company’s founder Fabio Giovanni Farneti also attended and spoke at the[…]

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Logbook: I’m investing in new offices

It has now been a year and a half since I wrote the last entry in my logbook and it is time to get back to writing again. I started this logbook during the COVID-19 pandemic as I wanted to understand what[…]

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Our Fabio Farneti to speak at the COMtecnica Conference

Our CEO Fabio Farneti will be speaking at the COMtecnica Conference, a two-day event to be held on 15 and 16 June 2022 in Venice (at Ca’ Foscari University), organised by COMtecnica SRL for COM&TEC Associazione Italiana per la Comunicazione Tecnica (the[…]

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PQ (Performance qualification) and the difference with process validation

The PQ (Performance Qualification) tests the functionality of the machine under standard production conditions. It is the first qualification phase in which the machine is tested “in process”, with the focus on the product and not just the equipment. PQ is part[…]

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Validation procedures: COM&TEC course, spokesman Fabio Farneti, SPAI Ceo

The training and refresher course “Validation procedures. Analysis, drafting, management”, organised by COM&TEC (Italian Association for Technical Communication), which will have as its speaker Fabio Giovanni Farneti, CEO Spai, will take place online on 25th March and 1st April 2022. The aim[…]

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Italy seeks industrial autonomy in the health sector

The Ministry of Economic Development has published a notice for Italian companies to submit projects in the health sector. The notice, which is part of the IPCEI (Important Project of Common European Interest), has a deadline of 28 February 2022 and aims[…]

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IQ OQ PQ validation

When we talk about IQ OQ PQ we mean the process of qualifying an automated machine: how it is composed, its operational processes and the performance achieved. The qualification of the equipment is part of the pharmaceutical validation process, which is the[…]

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GMP in the pharmaceutical sector: How to detect defects – Part Two

In the first part of our journey through the potential defects that can occur in the production and packaging of drugs, we focused on critical data printed on the packaging and defects in the drug itself. Today we will discuss the other[…]

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GMP in the pharmaceutical sector: How to detect defects – Part 1

GMP (Good Manufacturing Practices) in the pharmaceutical sector refers to the set of rules, procedures and guidelines according to which the production and packaging of drugs must be organised to ensure product quality, the safety of the end patient and the integrity[…]

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