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Wednesday, April 11 • 8:30am - 10:00am
Session N - GCP Track

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N-1  QRM, GCP and Quality Assurance - Building Quality into Clinical Trials

The adoption of ICH E6 R2 in the EU has created an interesting and challenging opportunity for the overall systems assuring quality in research; specifically, the application of Quality Risk Management (QRM) to GCP. QA professionals are an integral part of the overal quality assurance system. The QA role continues to evolve and expand as many QA departments assume more responsibility in addition to auditing - oversight of "CAPA" programs, Inspection readiness. This session will provide lessons learned from years of GMP application of QRM and QbD to GCP service quality and highlight the challenging opportunity for QA to support QRM in GCP.

Good Clinical Practices

Level of Content:

N-2  GCP Compliance and Audits in a Risk-Based Environment 

A formal program for GCP Compliance has become an integral means for meeting global regulatory expectations for clinical trial quality and as an integral part of a clinical Quality Management System approach. The advent of risk based approach to monitoring and agency’s risk based inspection program means that sponsors should be employing risk based audits as well to assure quality.  A robust CAPA (Corrective and Preventative Actions) process is also an essential component of a company’s Quality System to document that the actions taken to correct and to prevent the nonconformance were effective.   Using case studies, simulations and actual findings, participants will be able to describe how to approach clinical trials that fully comply with Good Clinical Practice expectations. Participants will also learn about the considerations for non compliance and the types of findings in an audit that can lead to regulatory problems.  This presentation will examine risk based auditing and how this approach can be implemented in your organization to assure quality data.

Good Clinical Practices

Level of Content:

N-3 Risk-Based Audit Program Planning : GCP System Audits

The goal of system audits is to establish that core clinical research processes are compliant with ICH guidelines, applicable local regulations and company policies and procedures, regardless of the priority level of the research being conducted. System audits allow an organization to leverage risk across  all therapeutic areas and research activity without having to touch every trial at any given time. A risk-based approach is more likely to ensure subject protection and overall study data integrity and allows sponsors to focus compliance efforts more efficiently. In this session, we will cover quality risk management concepts and explore ways to implement these concepts utilizing a risk-based approach for a GCP system audit program/plan.

Good Clinical Practices

Level of Content:

avatar for Penelope Przekop

Penelope Przekop

CEO/Principal Consultant, PDC Quality Consulting
Penelope Przekop is an outcome-driven Senior Executive and Thought Leader with more than 25 years of success across the biotech, pharmaceutical, healthcare, teaching hospital, clinical trials, manufacturing, and design industries. Her broad areas of expertise include quality assurance... Read More →


Liziel Concepcion

Liziel Concepcion, RQAP-GCP is Manager of R&D Clinical Quality at Allergan in Irvine, CA. She has led both directed and routine investigator site audits, service provider audits and system audits. She has cross-trained in GLP and CSV disciplines, resulting in her leading audits in... Read More →
avatar for Michael Hamrell

Michael Hamrell

MORIAH Consultants
Michael R. Hamrell is the President of MORIAH Consultants, a Regulatory Affairs/Clinical Research consulting firm located near Los Angeles, CA.  He has worked in drug development, clinical research and regulatory affairs for over 30 years.  Dr. Hamrell has a Ph.D. degree in Pharmacology... Read More →
avatar for Eric Humes

Eric Humes

Executive Director, QA, Medpace
Eric Humes is Executive Director, Quality Assurance at Medpace. Medpace is a full-service global contract research organization providing drug, biological and medical device development expertise from test-tube to marketing approval. Mr. Humes has a broad range of industry experience... Read More →

Wednesday April 11, 2018 8:30am - 10:00am PDT
Platinum 7&8