The Impact of GCP Guidance and the Importance of GAMP for Clinical Systems

This global SIG coordinates GAMP concepts in promoting the understanding of validation and compliance aspects within R&D, and of clinical computerized systems, with a focus on ensuring data integrity and patient safety. Focusing on actively demonstrating the application and value of GAMP principles in the R&D environment. Bringing IT quality and compliance accountability across entities involved in pre-commercial drug development life cycles.

Learning Goals:

  • Discuss how recent changes to ICH GCP E6 has impacted the validation of clinical systems.
  • Discuss the relevancy of associated industry guidance from the FDA, EMA, and MHRA.
  • Discuss how GAMP is playing a major role in the continued definition of clinical systems compliance.
Eric J. Staib
Vice President of Compliance
Genpact

Eric Staib is currently an Executive Director within Quality Assurance, at PRA Health Sciences. He has 18 years of pharmaceutical industry experience in various GXP areas including direct experience in quality systems development and management, QC microbiology, quality engineering, information technology, and laboratory operations. He holds a Bachelor of Science degree from James Madison University in Biology, a Master of Science degree from Temple University in Quality Assurance & Regulatory Affairs, a graduate certificate from Lehigh University in Project Management, and a MBA from Drexel University in Pharmaceutical Management. Eric is also Chair of the GAMP Americas Steering Committee, and Co-chairs a R&D and Clinical Systems Special Interest Group (SIG).

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