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Sunday, June 24 • 9:00am - 5:00pm
#40: Smart, Innovative Risk-Based Auditing: Shifting the Paradigm

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Component Type: Tutorial
CE: CME 6.50; IACET 6.50; RN 6.50

ICH E6 R2 states it loud and clear- “the scale, complexity, and cost of clinical trials have increased. Evolutions in technology and risk management processes offer new opportunities to increase efficiency and focus on relevant activities.” Time to revise your audit strategy! Join us as we develop audit plans that address quality in a targeted, efficient, nimble, calculated, risk-based manner. Learn to use technology to circumvent governmental travel advisories, weather hazards, resource limitations (auditors, time, budget), etc. without sacrificing audit goals. Garner the experience and expertise of department heads from Data Management, Clinical Operations, Information Technology, etc. to fulfill technical assessment/ oversight requirements. A wide range of audit types [vendor qualification/ re-assessment (CROs, pharmacovigilance, eCOA vendors, etc.), investigator sites, internal process audits (when the department is off-site), trial master files, GLP, etc.] will be discussed. An additional registration fee is required for all preconference short courses. Back to DIA 2018 Short Courses  

Who should attend?

This short course is designed for:
  • Quality personnel from sponsor companies, CROs, and vendors
  • Data Managers, Clinical Operations, CRAs, Clinical Scientists, Medical Monitors and other project leaders with ideas on how and what critical to quality data should be presented to auditors
  • Representatives/consultants of companies that provide auditing services

    Learning Objectives

    At the conclusion of this course, participants should be able to:
    • Identify which data is critical to quality using risk-based methodologies
    • Select novel methods to access documents and data when hosting/conducting a qualification, vendor, investigator site, or other GCP audit
    • Develop more comprehensive and cross functional audit plans for oversight activities of vendors and CROs



Speakers
avatar for Joanne Malia

Joanne Malia

Associate Director, Clinical Documentation Management, Regeneron Pharmaceuticals
Joanne Malia is Associate Director of Clinical Documentation Management at Regeneron Pharmaceuticals where she drives operational activities related to the implementation and management of an eTMF and associated clinical document management processes. She serves as the business owner... Read More →
avatar for Sarah Ann Silvers

Sarah Ann Silvers

Director, GCP Process Control and Compliance, Ce3
As Director, GCP Process Control & Compliance, Sarah oversees Ce3’s Clinical Quality Program- leading and conducting domestic and international audits (internal, sponsor, investigator, CRO, vendor, and TMF audits), writing procedure, educating staff and implementing regulation and... Read More →


Sunday June 24, 2018 9:00am - 5:00pm
Room 253C Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  • format json
  • Credit Type CME, IACET, RN
  • Tags Tutorial