🎤  Joy McElroy       |  📅  March 27, 2023   |  🕒  11 AM Eastern Time US

Why You Should Attend: 

This webinar will discuss the organizational oversight for both various products from both regulatory bodies, regulatory submission, filings, and the regulatory process for both agencies. Participants will learn the requirements for supply chain entities, establishment licensing and quality systems for both agencies. Examples of consequences for non-compliance will be given from both regulatory bodies. This webinar will also discuss the interactions and potential implications for the pharmaceutical, biologics and medical device industries.

Participants should attend this webinar to learn the differences between these 2 organizations, regulatory and compliance obligations, and the effects of manufacturing under both organization's guidelines.


Health Canada’s Health Products and Food Branch has a mandate of “minimizing health risk factors to Canadians while maximizing the safety provided by the regulatory system for health products”. The FDA’s mandate is “protecting the public health by assuring that… human and veterinary drugs, and vaccines and other biological products and medical devices intended for human use are safe and effective”. These are similar goals: protect the public by minimizing risks and maximizing safety and effectiveness of foods and drugs. Yet despite being borne from similar mission statements, these organizations behave very differently.

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 Should Attend:

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

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