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Significant Projects
Compliance and Validation in Pharmaceutical Industries:
- Basis of Design Logistics and Automation
- Validation of laboratory systems (DAQSTATION® Yokogawa videorecorder, NIR Thermo spectrophotometer, chromatographic sytem Dionex with Chromeleon® software)
- Qualification of Building Automation System for the environmental control of a sterile area
- Validation of application using "Documentum®"
- Validation of LIMS application
- Documentation for pan and tabletting machines
- Validation of Oracle® application
- Validation of "Material Handling System"
- Design Qualification of a project including automation of autoclaves, compounding, BAS/HVAC
- Validation of GIMAR® applications (Calibration and Maintenance management)
- Factory Acceptance Test of freeze-dryers and filling line
- Assessment of proprietary system AS400 based dedicated to warehousing from receiving to sending activities
- Validation of ABI Prism® SeqScape® by Applied Biosystem (a sequence comparison software tool designed for nucleotide and amino acid variant identification and allele library searching)
- Validation of BPCS® applications
- 21 CFR part 11 Assessment for SAP on different Company sites
- Project Management of the automation systems for new modernization project
- Packaging line validation
- Installation Qualification of Material Handling Control System
- Training courses on Metrology, GAMP®, automation, plant production and organization
- Supplier Audits
- FAT supervisory system (SCADA) FIX® (Intellution) for purified water production
- Validation of Distributed Control System Cube® Orsi, now Siemens
- Commissioning of Distributed Control System Fisher-Rosemount
- Validation of Laboratory Instrumentation System
- Validation of BPCS® and related network
- Testing and Validation documentation of Distributed Control System Yokogawa
- Supervision of validation activities for a Solvent Distribution & Storage Plant Control System
- Installation Qualification for LIMS, BPCS®, PHARM2, Integration Framework
- Supervision of validation activities and revision of SOP's
- Validation Workbook
- User training course for "Calibration Manager®" (Blue Mountain software)
- Special measurement studies
- ISO 9000 consultancy (e.g. ISO 9002 certification for a telecommunication Company)
For the following Clients:
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- Novartis Vaccines
- Simco
- Patheon
- Schering Plough
- ComMetodi
- Italfarmaco
- Abbott
- Takeda
- Biolab
- Chiesi farmaceutici
- Neopharmed (Merck group)
- Bidachem (Boehringer Ingelheim)
- Tecnimont
- IMA
- Poli Industria Chimica
- Pharmacia & Upjohn
- Faustfarm
- Sicor
- LCG-RBM,Serono
- Serono
- Pfizer
- Lepetit
- Synthelabo
- C.O.R. (Castelleone - Italy)
- ComForth (Budapest, Hungary)
- K.M.I. Inc. Boston (USA)
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16/07/2008 Previous activities
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Engineering and Construction Company
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1994
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Quality assurance and automation manager
- Quality procedures and ISO 9001 Manual for a small engineering/services Company
- Quality procedures ISO 9002 Manual for an industrial parts distribution Company
- LAN design and installation + personnel training
Philips Automation S.p.A.
and Industrial & Electroacoustical Division of Philips S.p.A.
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1988-1994
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- Marketing manager of the Line of Business Public Utilities (2 years)
- Technical Sales Support of the Line of Business 'Infrastructures' (1 year)
- Proposal Manager in the Health Care Automation task force (2 years)
- Project and Proposal Manager for Civil Automation (2 years)
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- Quality control procedures and ISO 9001 Manual
- Company Information System
- 'S.Siro' sports hall, Milan
- New hospital in Modena
- E.D.P. new facilities for 'Banca d'Italia'.Frascati (Rome)
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Snamprogetti ( ENI group)
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1982-1987
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- Project Manager of the Advanced Process Control Office (2 years)
- Project Specialist Leader for feasibility studies, proposal and design of Supervisory Process Control Systems, telemetry computerized systems (2 years)
- Senior computer system eng. of Process Instrumentation and Automation Division (2 years)
- Topping columns advanced control , IROM (Porto Marghera -Venice-Italy)
- Electrolitic Zinc Plant for SAMIM (Porto Vesme-Cagliari-Italy) and for Licensoring, Celiabinsk, formerly U.R.S.S.
- Oil, gas and water pipeline remote computerized control in Italy, Africa and Middle East
- Offshore facilities and unmanned platforms for Agip NAME, offshore Lybia
- Hydrocracker, Abu Dhabi, Middle Est
- Alkylation Unit, Warry, Nigeria
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S.I.R. Group(Società Italiana Resine)
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1973-1982
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- Senior System Engineer of Euteco Impianti SpA, Automation Office (3 years)
- System Engineer of Euteco SpA (3 years)
- Project leader of Officine Meccaniche Sarde, Process Computer Section (3 years)
- Software engineer of Officine di Porto Torres, Process Division (1 year)
- PVC plant (Rumianca-Assemini Italy)
- Acrylic Fibers (Porto Torres-Sardinia-Italy)
- Steam Cracking (Porto Torres-Sardinia-Italy)
- In-house process computer laboratory (Milan-Italy)
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Norgren Group (UK) c/o Arm Italia Norgren
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1972
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Design of special components for pneumatic automation
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Education
Professional Qualifications
Patent obtained
- "Sistema a due calcolatori con commutazione automatica in presenza di dati storici, per l'automazione di impianti industriali - Brevetto per invenzione industriale - "; Italy Patent n° 28809/1977 + UK patent n° 41357/1978 + Belgium Patent n° 871389/1979
Pubblications
Conferences, Seminars, Workshops
- Worshop ISPE/A.I.MAN. on "Predictive Maintenance and Calibration Management in the Pharmaceutical Industries"
; see agenda PDF file
 ; lecture presented from ispe web site
- An exampe of GPG associated to GAMP® presented at the ISPE night 2006 organized by the Italian Affiliate on July 6, 2006 in Milan
go to memo for GAMPit >>>
- The project of the GAMP® italiano presented at the Ispe xmas night 2005 organized by the Italian Affiliate during the ISPE Milan Conference on November 28, 2005
go to memo for GAMPit >>>
- "Soluzioni MES per la fabbrica integrata", round table c/o the magazine "Automazione e Strumentazione", March 2004;
see PDF file
; or the magazine Automazione e Strumentazione
- "L'automazione nell'industria farmaceutica: dal controllo di processo alla convalida" 45th National Conference of ANIPLA - the Italian Association for Automation - Nov. 2001
- "Dalle GAMP® al manuale per la convalida: breve storia della linea guida" Seminar on Control and Automation Systems for the production of medicines of the third Millennium, Certosa di Pontignano (SI), April 1998
- "GAMP96®: Customer requirement e guida per i fornitori" aicQ-ISPE joint Seminar on Computer System Validation in the Pharmaceutical Industries, May 7th, 1997
- "Dalle UNI EN ISO 9000 alla convalida dei sistemi" GISI Seminar on Operator Interface, May 16th 1996
- Mounthly report on the activity of the GISI working Group on System Engineering and Applications of Industrial Software; "Controllo di processo" magazine, starting Sept. 1995
Training courses
- "Introduction to compliance, GAMP® Good Automated Manufacturing Practice, 21 CFR part 11" c/o Patheon
- "Les tests de validation BPCS" c/o ELA MEDICAL, Montrouge (Paris, France)
- "21 CFR part 11 SAP R/3 Assessment" c/o Aventis at Neuville sur Saône (Cedex, France)
- "GAMP® Good Automated Manufacturing Practice" c/o Biolab, Vimodrone (MI, Italy)
Corsi, Seminari, Conferenze, Brevetti, Articoli tenuti o curati da Carlo Bestetti prima del 2002
- "Organizzazione aziendale" - nell'ambito dei Corsi "Area Professionalizzante" classi del 4°anno Elettrotecnici e Elettronici IPSIA "Puglisi" - dal 1996 al 2001
- "Cenni di Storia dei sistemi d'automazione con calcolatore nell'industria; alcuni esempi reali" + "Esempi applicativi di Telecontrollo" + "dalle origini alla Computer System Validation" + "Casi di Automazione, alcuni esempi reali" nell'ambito dei corsi post diploma per Tecnici di Controllo Processi Industriali - ENAIP, Dalmine - dal 1995 al 2000
- "Casi di Automazione, alcuni esempi reali" nell'ambito dei Corsi "Area Professionalizzante" classi del 5°anno Elettrotecnici IPSIA "Puglisi" - dal 1996 al 1997
- Un nuovo modo di lavorare - Controllo di processo - dic. '94
- "Sistema di campionamento... per misure analitiche "campione" " nell'allegato ad "Automazione e strumentazione", dicembre '94
- Sistema di campionamento... per misure analitiche "campione" - allegato ad "Automazione e strumentazione", dic. '94
- Bias '93, SCADA su DEC Alpha in rete con PC integrato con immagini video
- Il telecontrollo dell'acquedotto della Romagna - Convegno su Telecontrolli e Telemisure nei sistemi acquedottistici - Politecnico di Torino - feb.'93
- Introduzione all'informatica dei calcolatori di processo - Snamprogetti - Corso per il personale del petrolchimico di Gela (Sicilia)
- Esperienze di progettazione di un calcolatore di processo per impianti di raffineria - Conferenza Snamprogetti, S. Donato Mil. - set. '85
- Training hardware per il personale della raffineria ADNOC di Ruwais (ABU DHABI)- mag.'85
- L'impiego dei calcolatori nei processi industriali / Computerized systems for control, supervision, management of industrial processes - Training of Zypeb engineers, Zhong Yuan oil field (Rep. of China) - apr.'85
- Il telecontrollo negli impianti offshore non presidiati - Bestetti, Carniti, Orlandini - Conferenza Snamprogetti, S. Donato Mil. e Fano - feb. '85
- Sistemi computerizzati di controllo sugli impianti offshore; un esempio - Bestetti, Panigada - Conferenza Snamprogetti, S. Donato Mil. - giu.. '84
- Considerations on computer automation of P.V.C. plants - Piras, Bestetti - Chem+Tech Exibition & Conference on Computer applications in Chemical Processing Industry - Bombay (India) - mar.'80
- Computer control system for automation of mercury cell chlorine plants - Piras, Boselli, Bestetti - ING.CHIM.ITAL., V.15, N. 11-12,NOV.-DIC. 1979
- Sistema a due calcolatori con commutazione automatica in presenza di dati storici, per l'automazione di impianti industriali - Brevetto per invenzione industriale - ott.'77
- Sistema di automazione con calcolatore per l'impianto PVC della Rumianca ad Assemini (CA); calcolatore digitale in linea per controllo sequenziale - Manuale operativo ed addestramento del personale - sett.'77
- Programmazione strutturata - Ufficio automazione impianti S.I.R. - ott.'75
- Automazione oleodinamica e pneumatica - A.N.C.I.F.A.P. Arese (Mi) - 1970/ '71
- Automazione oleodinamica e pneumatica - Ruggeri (Politecnico, Mi) - ex ISTIM (ora EMIT-LAS), Milano - 1970/ '71
- Teorie e Tecniche della Gestione Industriale - Brandolese e Roversi (Politecnico, Mi) - Corso libero al Politecnico di Milano - 1970/ '71
Associations
Awards
- ISPE Special Achievement Award, ISPE Annual Meeting San Diego (CA, USA), Nov. 1996
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- Transfusion and transplant immunology centre c/o the Milan General Hospital, silver award
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Languages
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Italian
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English
French
German
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(fluent),
(fluent),
(5 years at Goethe Institut in Milan).
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"GAMP III®, guida ai sistemi con calcolatore per il nuovo millennio", "Notiziario Chimico Farmaceutico", May '98
