Maurizio Della Pietra

Current

• QA Validation expert at Kedrion S.p.A.

Past

• IT&CS Validation Consultant; QA CS&A Consultant at CTP Tecnologie di Processo S.p.A
• Physics Researcher (PRIN project) at University of Naples Federico II

Education

• Università degli Studi di Napoli 'Federico II'

Recommended

2 people have recommended Maurizio

Connections

24 connections

Industry

Pharmaceuticals

Websites

• My Website
• My cultural site

Maurizio Della Pietra’s Summary

Validation Consultant with broad experience in all aspects of quality assurance for computer systems and applications (21 CFR PART 11 compliance). Direct experiences in project scheduling and management.

Maurizio Della Pietra’s Specialties:

Risk Assessment and Analysis; GAMP V-cycle Validation; 21 CFR PART 11;
CSV on SCADA, MES, LIMS, CDAS systems.

Maurizio Della Pietra’s Experience

• QA Validation expert

  Kedrion S.p.A.

  (Privately Held; Pharmaceuticals industry)

  January 2009 — Present (7 months)

• IT&CS Validation Consultant; QA CS&A Consultant

  CTP Tecnologie di Processo S.p.A

  (Pharmaceuticals industry)

  January 2006 — December 2008 (3 years)

  works done:
  CSV on SCADA (Supervisory Control And Data Acquisition) software;
  CSV on MES (Manufactory Execution System) software;
  CSV on planned maintenance and service software;
  CSV on LIMS (Laboratory Information Management System);
  CSV on CDAS (chromatography data acquisition system);
  CSV on Custom Software Systems (GAMP category 5);
  Project Management (IT and infrastructure implementation);
  Risk Assessments and Analyses;
  SOPs and Technical documents review.
  
  Customers:
  Astellas Pharma Europe B.V.; Sanofi-Aventis; IMA; Wyeth-Lederle; Patheon; Novartis.

• Physics Researcher (PRIN project)

  University of Naples Federico II

  (Educational Institution; 5001-10,000 employees; Research industry)

  June 2004 — December 2005 (1 year 7 months)

  Role and Responsability: Hardware, firmware e software engineer; Quality test and Quality certification at CERN of Geneva (from November 2004 to January 2005);
  
  Technical works done: Environmental temperature controller based on the LM77 sensor on FPGA XILINX XC3100 chipset;
  First level board of ICARUS Trigger system (Local Trigger Control Unit) based on FPGA XILINX SPARTAN 2 (firmware in VHDL language).
  LTCU management software in NI LabView environment based on RS232 COM protocol;
  Second level board of ICARUS Trigger system (Trigger Control Unit) based on FPGA XILINX SPARTAN 2 (firmware implemented in VHDL language).
  LTCU controller board based on VME bus
  Multiplexing and preamplifier board for photomultipliers data acquisition (WARP experiment)

Maurizio Della Pietra’s Education

• Università degli Studi di Napoli 'Federico II'

  1997 — 2004

Additional Information

Maurizio Della Pietra’s Websites:

• My Website
• My cultural site

Maurizio Della Pietra’s Groups:

•    CTP SYSTEM actual and former colleagues

Maurizio Della Pietra’s Contact Settings

Interested In:

• career opportunities
• consulting offers
• new ventures
• job inquiries
• expertise requests
• business deals
• reference requests
• getting back in touch