FDA rules for R&D also: root cause analysis and failure investigations

Summary form only given. This session discusses successful methodologies and regulatory documentation required for Research and Development scientists and engineers during development, animal and clinical testing and marketing of medical devices and drug device combinations. The session will be a guided roundtable in which the development lifecycle will be discussed in terms of common regulatory pitfalls. Group experiences will be shared during the session. Topics discussed will include: documentation required for various regulatory pathways, lab organization under GMPs for R&D vs. GMPs for QC, and FDA audit experiences in the R&D lab.