We are participants in the development process, impacting the lives of patients and improving the human condition. Global regulators expect us to comply with requirements to ensure data integrity and subject safety throughout the development life cycle. When they come to review the processes, paper and people involved we must be ready. This visit is expected with known methods so why is there so much angst for an inspection? Taking a team approach, identify the strengths of your resources and aligning those to an inspection "game plan" brings confidence to any inspection team.Speakers:Kara Harrison, MS, RAC, RQAP-GCPProject ManagementFDA Quality and Regulatory Consultants
Michelleanne BradleyConsultant & PresidentMetis Consulting Services
To purchase contact hour, please click here.*THIS EVENT IS A REPLAY OF A PRESENTATION FROM THE 2019 GLOBAL CONFERENCE AND IS REMOTE ACCESS ONLY.
With more than 20,000 members, the Association of Clinical Research Professionals (ACRP) is the only non-profit solely dedicated to representing, supporting, and advocating for clinical research professionals. ACRP supports individuals and life science organizations globally by providing community, education, and credentialing programs. Founded in 1976, ACRP is a registered 501(c)(3) charitable organization whose mission is to promote excellence in clinical research and whose vision is that clinical research is performed ethically, responsibly, and professionally everywhere in the world.
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