FDA Vs Health Canada

Duration: 60 Minutes
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.
FDA Regulation
Instructor: Angela K. Dunston
Product ID: 500924

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
  • Cultural Considerations
  • Successful Interactions
Who can Benefit:
  • Regulatory Affairs
  • Inspection Readiness/Preparedness
  • Sr. Directors/Directors
  • QA Specialists (Senior Level)
  • Compliance Professionals
  • Quality System Consultants
$375
Recorded Session for one participant
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  $500.00 Training CD
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  $600.00 Training USB Flash Drive
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How it works
Live Session - How it works
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  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
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, 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.
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