Laurie Auerbach

Company: Compliance Prodigies LLC

Job title: President and Principal Consultant

Seminars:

Essential Performance Requirements of Injectable Devices for Submission & Approval 11:35 am

Ensuring your combination product meets FDA expectations for Essential Performance Requirements is critical for any sponsor today seeking FDA marketing approval. Navigating the ambiguities and inconsistencies with EPR expectations in the absence of any formal guidance is a pain point for most sponsors. This workshop will introduce the concept of EPRs, share the latest FDA…Read more

day: Pre-Conference Workshops