FDA vs Health Canada

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.

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 Session :

  • 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:

  • Manufacturing Departments
  • Supply Chain Departments
  • Quality Control Departments
  • Quality Assurance Departments
  • Regulatory Affairs Departments
  • Compliance Departments
  • Documentation Departments
  • Audit Departments

FDB2281

Rachelle D'Souza

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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  • 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