Compliance Trainings, Online
2016-05-11
Description : 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 Cultural Considerations New Collaborative Initiative Successful Interactions Who Will Benefit: Regulatory Affairs Department Senior Directors and Directors QA Specialists (Senior Level) Compliance Department Quality System Department Staff responsible for Inspection Readiness/Preparedness
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