Areas of Expertise:US FDA(21 CFR Parts 210 and 211, Parts 110, 111,117 and 820), NMPA, PIC/s, EU GMP,,HACCP, Chinese GMP for Health Food (GB17405-1998), ISO22000, ISO13485, GxP audit,QA and Risk Assessment in Pharmaceuticals ,Compliance Auditing and Gap Analysis, FDA Inspection Support, GxP Training, Analytical Testing, Validation. extensive GxP audit and laboratory management, experience.