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GCP Compliance & Quality Assurance – Audit & Inspection

Feb 27 2014 8:00AM - Feb 28 2014 5:00PM

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Overview 

This two-day course provides an in-depth, practical, and interactive forum so participants can better understand the critical aspects of GCP and, especially, how to detect deviations  from GCP and regulations, how to prepare for a regulatory inspection and a sponsor or independent audit, what tools are available to conduct an assessment or investigation when  such deviations have been  observed and how to conduct an effective CAPA (Corrective Actions and Preventive Actions) program following an inspection or audit, or upon the detection of deficiencies or breaches.

The course will be supported with real-life examples and will deliver a comprehensive understanding of internationally accepted and required principles of the management of deviations from GCP and regulatory requirements.

Who Should Attend 

  • Clinical Study Directors
  • Clinical Trials Managers
  • Clinical Trial Monitors
  • Study Coordinators
  • Study Project Managers
  • Quality Assurance Staff and Auditors
  • Pharmacovigilance Compliance Staff

Learning Objectives 

  • Gain a better understanding of the GCP requirements and the challenges when deviations from requirements or non-compliance are possible or already observed
  • Learn what tools can be used to detect non-compliance
  • Better understand how the audit and inspection processes work
  • Learn how to use auditing techniques as a tool in study management and monitoring
  • Learn what the regulators expectations are in terms of CAPA management and CAPA completion
  • Implement effectively CAPAs
  • Learn how CAPAs are implemented successfully and what pitfalls must be avoided

Contact Information 

For general inquiries and registration, contact
Mr. Fei XIE
Phone +86.10.6260.2240
fei.xie@diachina.org or dia@diachina.org

Registration Fees 

Member

Charitable Nonprofit/Academia Member
¥1800.00
Member Government
¥1800.00
Member Standard
¥2400.00

Non-Member

Charitable Nonprofit/Academia Nonmember
¥2600.00
NonMember Government
¥2600.00
NonMember Standard
¥3200.00
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