Training Course Syllabus:
This training program will elucidate the similarities and differences between the FDA and Health Canada promulgation s of regulations impact preparation. The course will also offer a review of the background and history behind the FDA and Health Canada.
Successful interaction with regulatory agencies can mean the difference between product license approvals and rejections; and the difference between successful and unsuccessful PAI and routine inspections. Not all regulatory bodies are created equal. Things that are important for one agency may be different for another agency. Understanding the similarities and differences between regulatory agencies helps organizations prepare specifically to address individual agency concerns.
Why Should you Attend:
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 webinar will be 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 and this course will explore cultural considerations that have been proved to be helpful.
Objectives of the Presentation:Short History - FDA
Short History - Health Canada
Similarities between FDA and Health Canada
Differences between FDA and Health Canada