PBE expert Inc


Validation & GMP Compliance Director

Marco Charron

Marco Charron Consult, Senior. Validation & Compliance Specialist according to cGMP regulatory requirements of Health Canada, EMA and US FDA :

  • Protocols (QIOQ/PQ) development, tests execution, analysis and report writing;
  •  URS, FDS writing;
  • Factory Acceptance Test (FAT) and Site Acceptance Test (SAT) development;
  •  Validation Master Plan development;Environmental program development and implantation;
  • SOP’s writing;
  • Validation project coordonator and management;
  • Technical advisor for all critical systems and clean utilities
  • Environmental control and cleanroom assessment implementation (ISO14644);
  • cGMP Technical support regarding to FDA and EMEA regulatory compliance.


  • 2018: Validation/Compliance Specialist, PBE Expert, Laval, Canada
  • 2017: Validation Consultant, Spectrum Pharma, Montréal Canada,
  • 2016: Validation Consultant, Galerma Canada Inc, Montréal, Canada
  • 2014: Validation Consultant, Valeant, Laval, Canada
  • 2013: Validation Consultant, Sandoz, Boucherville, Canada
  • 2010: Validation Consultant, Sanof-Aventis, Laval, Canada
  • 2010: Validation Consultant, Lantheus Medical Imaging, Montréal, Canada
  • 2010: Validation Consultant, Wimpak Heat Seal Packaging Inc., Vaudreil, Canada

Expertise & Compétences

  • GMP regulatory compliance audit
  • Commissioning, FAT, SAT, IQ, OQ, PQ
  • Process Validation
  • Cleaning & Sterilisation Validation
  • Warehouse Mapping & Refrigeration
  • Quality Assurance & ISO 9001 Certification
  • Batch Release
  • Regulatory Affairs: DIN, NPN, DEL & MDEL
  • QPIC
  • Pre-Approval Inspection (PAI)



Pour toute information commerciale, de partenariat et marketing avec PBE Expert Inc

+1 (514) 616-2692


1347, rue Bergar, Laval, H7L 4Z7, Qc, Canada

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+(216) 96-751-330



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