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.