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3
9:00 Registrazione partecipanti 9:30 Benvenuto, saluti ist
9:00 Registrazione partecipanti 9:30 Benvenuto, saluti istituzionali e introduzione Ing. Alessandro Bove, Direttore FIP 9:45 Presentazione del corso Ing. Andrea Angelo Mussolin, Responsabile scientifico del corso, Presidente Palladio Consulting Srl 10:00 Introduzione alla Contamination Control Strategy Dott. Claudio Ernesto M. Manzati, CEO Lean Institute Italia Sas, Qualified Person Neotron Pharma Spa 11:00 Coffee break 11:30 Novità del nuovo Eudralex GMP Annex 1 in revisione Dott. Gilberto Dalmaso, Presidente GDM Pharma Consulting, docente tecnico PDA, relatore ISPE 12:30 Pausa pranzo 14:00 Deviazioni ricorrenti negli impianti di produzione sterili Dott.ssa Adele Romani, Ufficio Ispezioni e Autorizza- zioni GMP Medicinali AIFA (Agenzia Italiana Farmaco) 15:30 Coffee break 16:00 Nuovo approccio Risk-Based alle Qualifiche e alle Convalide per nuovi locali e apparecchiature Dott. Marco Benvenuti, Corporate Operations Director Fidia Farmaceutici Spa 17:00 Dibattito 17:30 Chiusura dei lavori
9:00 Registrazione partecipanti 9:45 Regolamento (UE) 2017
9:00 Registrazione partecipanti 9:45 Regolamento (UE) 2017/745 relativo ai dispositivi medici - Requisiti generali di sicurezza e prestazioni: infezione e contaminazione microbica Dott. Franco Del Bianco, QMS Lead Auditor 11:00 Coffee break 11:30 Efficienza energetica in cleanroom e novità intro- dotte dalla ISO 14644-16:2019 Ing. Andrea Angelo Mussolin, Responsabile scientifico del corso, Presidente Palladio Consulting Srl 12:30 Pausa pranzo 14:00 Ottimizzazione dei costi di gestione e energy saving dei sistemi di filtrazione aria per cleanroom Ing. Raffaele Pieri, Life Science Segment Maganer Camfil Italia 15:00 Soluzioni costruttive per le strutture secondarie in cleanroom in risposta sismica secondo NTC 2018 Mr. Tomaso Nigris, Managing Director Nicomac Europe srl 15:45 Coffee break 16:15 L’integrazione di impianti produttivi in area sterile. Benefici dell’industria 4.0 e approccio alla Cyber- security Ing. Luca Songia, Project Manager Life Science Eurotherm Srl by Schneider electric 17:00 Test finale di valutazione e chiusura dei lavori
Il corso intende fornire le conoscenze di base per la progettaz
Il corso intende fornire le conoscenze di base per la progettazione, la costruzione la qualifica e la manutenzione di una camera bianca per i settori farmaceutico, chimico, cosmetico, alimentare, ospedaliero e affini.
Sponsor partners
Sponsor partners
CORSO AVANZATO CAMERE BIANCHE E AMBIENTI A CONTAMINAZIONE CON
CORSO AVANZATO CAMERE BIANCHE E AMBIENTI A CONTAMINAZIONE CONTROLLATA
Il corso si svolgerà a Vicenza presso la sede di Palladio Consu
Il corso si svolgerà a Vicenza presso la sede di Palladio Consulting srl, in Piazza Pontelandolfo, 104. Per Informazioni: info@palladioconsulting.com
Livello 4
Venerdì 25 Settembre 2020
Venerdì 25 Settembre 2020
Giovedì 16 Maggio 2019
Giovedì 24 Settembre 2020
26 novembre 2021 Vicenza
26 novembre 2021 Vicenza
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