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.
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).