For Immediate Release: October 24, 2017
513-579-9911 x 12523
Medpace to Present on Quality Risk Management at 5th Annual Global QA Conference in Edinburgh
CINCINNATI, OH — (October 24, 2017) – Medpace (MEDP), a scientifically-driven, global full-service clinical research organization (CRO), announced that Eric Humes, Medpace’s Executive Director of Quality Assurance, will be presenting during a session at the 5th Global QA conference in Edinburgh. Details about his presentation follow:
WHEN: 1 November 2017
TRACK: Stream B Quality Tools Session 4
TOPIC: Quality Risk Management
Quality Risk Management (QRM) has been applied in the manufacturing space for over a decade (Pharmaceutical Quality Systems/ICH Q9). The recently revised addendum to ICH E6 introduces the concept of QRM to GCP. At the heart of QRM, in the context of GCP, is building quality into the lifecycle of the trial; from study design to archival, ensuring subject safety and data quality/integrity. The quality business processes integral to an effective and sustainable GCP-regulated Quality Management System (QMS) include but are not limited to monitoring, supplier/ vendor management, auditing and issue mitigation (e.g., CAPA program). The focus of this discussion will be opportunities to enhance and improve the GCP ‘CAPA program’, through the application of QRM and lessons learned from GMP. A key principle of QRM centers on the level of effort, formality and documentation being commensurate with the level of risk – better stated; avoiding the ‘CAPA’d to death’ syndrome.
For more information, visit the conference website.
About Eric Humes
Eric Humes is the Executive Director of Quality Assurance at Medpace. He has 23+ years of industry experience in GMP, GLP and GCP, specializing in the development of Quality Systems for GXP regulatory compliance and ISO Certification. He is a certified trainer and has received his RQAP-GLP certification from SQA. He previously served as chair of the SQA Education Committee (Ed-Com), Clinical Specialty Section (CSS) and editorial board of the DIA’s Peach Initiative. He holds a B.S. in Biochemistry from the University of Maryland and a certificate in International Business Management from the Smurfit School of Business.
Medpace is a scientifically-driven, global, full-service clinical contract research organization (CRO) providing Phase I-IV clinical development services to the biotechnology, pharmaceutical and medical device industries. Medpace’s mission is to accelerate the global development of safe and effective medical therapeutics through its physician-led, high-science, and disciplined operating approach that leverages local regulatory and deep therapeutic expertise across all major areas including oncology, cardiology, metabolic disease, endocrinology, central nervous system and anti-viral and anti-infective. Headquartered in Cincinnati, Ohio, Medpace employs approximately 2,500 people across 35 countries.