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.
Kara Harrison, MS, RAC, RQAP-GCP
FDA Quality and Regulatory Consultants
Consultant & President
Metis Consulting Services
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*THIS EVENT IS A REPLAY OF A PRESENTATION FROM THE 2019 GLOBAL CONFERENCE AND IS REMOTE ACCESS ONLY.