Center for Professional Innovation & Education, Inc., Los Angeles, CA
May 20 - 22, 2013
This course provides a comprehensive overview of the regulations and guidance documents, along with the critical processes and procedures that should be in place in a PET facility to be in alignment with these new expectations. An overview of how FDA enforces these regulations is also provided. Parallels will be drawn between the pharmaceutical and device industries to illustrate requirements, expectations, and enforcement actions. Additionally, participants will gain an understanding of potential future regulatory measures. Hands on activities, case studies, and interactive discussions will be utilized in the course.
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