FDA vs Health Canada


Instructor: Rachelle D Souza
Product ID: 704862

  • Duration: 60 Min
This webinar will provide an understanding of the organizational hierarchy of FDA and Health Canada, your regulatory and quality compliance obligations and the implications of the interactions between these two agencies on your organization.
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Why Should You Attend:

The Food and Drug Administration (FDA) and Health Canada are the regulatory authorities for USA & Canada respectively. If you are a manufacturer and want to launch or maintain your product on the North American market, be it a drug, medical device, dietary supplement, cosmetic or food, you need to ensure and maintain compliance with the regulatory requirements of these authorities. Regulatory compliance requirements also exist for other entities in the supply chain like packagers, labelers, lab testers, importers, distributors and wholesalers.

Attend this training for an understanding of the organizational hierarchy of FDA & Health Canada, your regulatory and quality compliance obligations and the implications of the interactions between these two agencies on your organization.

Areas Covered in the Webinar:

  • FDA vs. Health Canada – Organizational Oversight for Different Product Types
  • FDA vs. Health Canada – Regulatory Submissions / Filings and / or Regulatory Processes for Different Product Types
  • FDA vs. Health Canada – Quality Systems & Establishment Licensing, Requirements for Supply Chain Entities
  • Examples of Consequences for Non-Compliance with Regulatory Authorities
  • FDA & Health Canada – Interactions & Potential Implications for industry

Who Will Benefit:

Professionals from Drug, Medical Device, Natural Health Product, Dietary Supplement, Cosmetic & Food Industries will benefit from this training. Start-ups, Virtually Run & Multi-national Manufacturers and other supply chain entities e.g. Importers, distributors, packagers, labelers, testers, wholesalers will also benefit. People in the following job functions, will benefit from this session:

  • Manufacturing
  • Supply chain
  • Quality control
  • Quality assurance
  • Regulatory affairs
  • Compliance
  • Documentation
  • Audit
Instructor Profile:
Rachelle D Souza

Rachelle D Souza
CEO and President, Regulatory Heights Inc

Rachelle D’Souza, CEO of Regulatory Heights Inc., has successfully licensed various medical and consumer products and facilities with international regulatory authorities / agencies for multinational and start-up companies.

Her expertise also includes clinical trial master file documentation, and the design and maintenance of globally compliant quality, safety / pharmacovigilance and medical information systems.

At Regulatory Heights Inc., Rachelle continuously monitors the current regulatory environment and utilizes regulatory intelligence as a strategic business driver for her clientele. Her numerous articles on the latest international regulatory developments have been published in print and on-line by regulatory professional associations and industry magazines around the world.

Her versatility has enabled Regulatory Heights Inc. to support companies, in particular, start-ups with the licensing of their drugs and medical devices in international markets.

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Our refund policy is governed by individual products and services refund policy mentioned against each of offerings. However in absence of specific refund policy of an offering below refund policy will be effective.
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. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar 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 [email protected] call +1-888-717-2436 (Toll Free).




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