Understanding FDA and Health Canada

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 or participate in the supply chain 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.

Attend this training for an understanding of the how FDA and Health Canada are organized, their cooperation and leveraging capabilities, regulatory and compliance oversight and the implications for your organization.

Areas Covered in the Webinar:

• Organizational Structure
• Scope of Oversight for Different Products
• Regulatory Pathways
• Quality Management Systems, Registration and Listing, and Licensing Requirements
• Administrative, Civil and Criminal Remedies for Non-Compliance
• Implications of Interagency Leveraging and Cooperation

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

Ricki Chase
President, RChase Consulting LLC

Ricki Chase is a quality compliance professional with over 30 years of experience in regulatory enforcement roles and quality consulting leadership. Ms. Chase worked in multiple jurisdictions, including 20 years of federal service. While at the US Food and Drug Administration, Ms. Chase was an Investigator in the Office of Regulatory Affairs responsible for assessing all regulated commodities. She advanced her career through medical device specialist, Supervisory Investigator and Director of Investigations. Ms. Chase’s responsibilities included leading offices and programs as well as developing enforcement cases and working with industry partners

After leaving the US FDA, Ms. Chase worked for Lachman Consultant Services, Inc., developing the Medical Device/Combination Products business line as Vice President, and partnering with industry to create innovative and efficient solutions for regulatory compliance preparedness, regulatory oversight responses and remediation of complex quality compliance challenges facing multinational organizations across the pharmaceutical, biotech and medical device sectors. As President of RChase Consulting LLC, Ms. Chase works with industry, academia and non-profits within the life sciences to develop, support and grow successful people, products and companies in pursuit of bringing necessary and life changing medical products to the hands of the users.

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