What to expect from a GCP audit/inspection?

Online Training Id: GCP-004

 

Level: Intermediate

Duration: 2 hrs

A GCP audit is conducted with the aim of determine whether or not the clinical trial is/was conducted according to the regulations and guidance that govern clinical research. This course will provide an overview of the main auditing techniques used by an auditor and/or a regulatory authority’s inspector as well as the most frequent findings from Clinical Investigational Sites.

Learning Objectives:

  • Discuss how quality assurance differs from quality control and who should be  responsible for each

  • Describe the typical GCP audit steps and conduction

  • Outline best practices when receiving a GCP audit/inspection

  • Review recent noncompliance trends and regulatory focus for Sites and  Sponsors

Who Should Enroll :

All those involved in Clinical Research, particularly QA auditors, CRAs, PMs, SCs and investigators– Sponsors / CROs (e.g. CRAs, PMs, CRA Managers)

Author:

 

 

 

 

 

 

 

 

 

Thomas G. (Gary) Bird, Ph.D. is co-founder of PharmaConsult Global, Ltd., an international cooperative supplying GXP quality consulting services and  President, PharmaConsult-US, LLC. He served as Director of Corporate Quality for GTx, Inc. (Memphis, TN, USA) from 2003 until 2013 and was responsible for confirming all non-clinical (GLP), manufacturing (GMP), and clinical trial (GCP) related activities were conducted in compliance with appropriate laws and regulations. 

He developed all Quality Systems to support the growth of the small pharmaceutical company and led an NDA submission team.  Prior to joining GTx, he was with Eli Lilly and Company from 1995 to 2003, serving as Senior Quality Advisor for Biotechnology in Corporate Quality Assurance and Senior Regulatory Consultant, CMC Regulator Affairs. 

He was with the FDA from 1990 to 1995 in both CDER and CBER where he was Assistant to the Deputy Director.  During his time with Lilly and FDA he represented both PhRMA and the FDA in the International Conference on Harmonization negotiations on four (4) different agreed guidances. 

He approved and signed documents on behalf of both organizations.   He was secretary for all ICH Working Committees for documents on which he worked including Biotech Stability (Q5C), Comparability of Biotechnological/Biological Products Subject to Changes in their Manufacturing Process (Q5E); Specifications:  Test Procedures and Acceptance Criteria for Biotechnological/Biological Products (Q6B) and  The Common Technical Document for CMC Submissions (M4).   Dr. Bird holds a Ph.D. in Biochemistry/Entomology from Mississippi State University.

Dr. Gary Bird  PH.D.

GBP $200.00

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