FDA Vs Health Canada

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.

Areas Covered in the Webinar:

• Short History - FDA
• Short History - Health Canada
• Similarities between FDA and Health Canada
• Differences between FDA and Health Canada
• Cultural Considerations
• Successful Interactions

Who Will Benefit:

• Regulatory Affairs
• Inspection Readiness/Preparedness
• Sr. Directors/Directors
• QA Specialists (Senior Level)
• Compliance Professionals
• Quality System Consultants

Instructor Profile:

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, Ms. Dunston 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, she has worked with US FDA agents to ensure compliance for her clients.

Her international experience 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 offered trainings on procedures from the V-suite to the manufacturing floor. Ms. Dunston works closely with the company’s staff to ensure a cohesive transition for non-compliance to policy approval.

Topic Background:

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.

Follow us :