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Hotel Nikko Shanghai

Jan 11, 2018 3:00 PM - Jan 12, 2018 11:00 PM

No.488, Yanyanxilu Rd., Changning dist., 200000 Shanghai, China

GCP Inspection Management Workshop-From Self-inspection (inspection readliness) to Inspection Management

Overview

Co-hosted by: CQAF

The course targets Sponsor/ CRO GCP quality professionals (Auditors, Quality Manager, Inspection Manager, etc.), hospital GCP officers and Investigators who are involved in an inspection directly. Will cover the essential knowledges for the Clinical Trial Quality Life Cycle Management, as well the handful skills and tools to prepare and host CFDA inspection. The course have invited some most senior Auditors from China Quality Assurance Forum (CQAF) to design, lead and facilitate the whole course.

Learning objectives

  • The insight and prospect of CFDA NDA related GCP inspections
  • The handful skills and tools to prepare and host CFDA inspection
  • Response and follow-up to inspection findings
  • Global knowledge and experience with other health authority inspections

Program Committee

  • Hannah  Chen, MD
    Hannah Chen, MD Consultant
    Beijing XiaoTongMingDa Technology Ltd., China
  • Liping  Zhou
    Liping Zhou Sr. Director, Quality Assurance, China and Asia (excl. JP)
    Pfizer, China

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