For the life science industry, interaction with various regulatory agencies is a must. Successful interactions lead to first time approvals for licensure as well as minimum to no observations during inspections. Successful interactions lead to successful outcomes.
This training is the first step in unraveling the keys to successful interactions with the US FDA and Health Canada officials. The training will discuss similarities and differences between the two agencies. Compliance in these areas have been shown to lead to successful FDA and Health Canada inspections We will explore cultural considerations that have been proved to be helpful.
Areas Covered in the Session :
Short History FDA and Health Canada
Similarities between FDA and Health Canada
Differences between FDA and Health Canada
New Collaborative Initiative
Who Will Benefit:
Regulatory Affairs Department
Senior Directors and Directors
QA Specialists (Senior Level)
Quality System Department
Staff responsible for Inspection Readiness/Preparedness