FDA vs Health Canada

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

Angela K. Dunston

Angela K. Dunston has over 20 years of experience in manufacturing and laboratory quality and compliance in the pharmaceutical, biotechnology, and medical device (diagnostics) industries. Her expertise is in defining, implementing, and maintaining Quality Management Systems that are cohesive and properly interact with all areas of the organization.

During these 20 years, Angela has actively participated in global regulatory inspections to include US FDA in the capacity of host, SME, and scribe. Through consulting with a variety of companies, Angela has worked with US FDA agents to ensure compliance for her clients.

The international experience obtained has assisted global organizations such as Johnson and Johnson, the Croda Corporation, Novartis, Hospira, Sanofi Pasteur, and Quintiles to exceed regulatory expectations. She has authored company best practices manuals and has trained on those procedures from the V-suite to the manufacturing floor. Angela works closely with the company’s staff to ensure a cohesive transition for non-compliance to policy approval.

  Go PRIME   🛈 $ 240 SELECT
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  • Login Information with Password to join the session, 24 hours prior to the webinar
  • Presentation Handout in .pdf format
  • Presentation from the Speaker
  • Feedback form
  • Certificate of Attendance
  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance