ComplianceOnline

FDA Vs Health Canada

Instructor: Angela Dunston
Product ID: 703970
  • Duration: 60 Min

recorded version

$249.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

$399.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-565-8542

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Read Frequently Asked Questions

This training program will elucidate the similarities and differences between the FDA and Health Canada promulgations of regulations impact preparation. The course will also offer a review of the background and history behind the FDA and 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.

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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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