Carlo Bestetti

Validation Consultant
Compliance & Automation

Carlo Bestetti

Via Ramazzotti, 11
I-20052 Monza (MI)
Tel. e Fax +39
Cell. +39 338.17.19.674

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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:

Merck Sharp & Dohme


Foster Wheeler

Cilag, J&J

ELA Medical, SNIA group

Aventis / HMR


  • 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)

Previous activities




Professional Qualifications



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