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 Should Attend: Manufacturing Departments Supply Chain Departments Quality Control Departments Quality Assurance Departments Regulatory Affairs Departments Compliance Departments Documentation Departments Audit Departments


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