Preparing your Supply Chain for the Regulatory Provisions

Preparing your Supply Chain for the Regulatory Provisions

This presentation explores the Health Canada Guide-00069 regulations and requirements in Canada and provides detailed examples of compliance and non-compliance regarding:

  • Review guidelines for products in transit: stability data requirements and temperature mapping
  • Discus the regulatory scope of temperature monitoring for CRT
  • Risk valuation and mitigation and analyze examples of compliance and non-compliance
  • How to implement locally to distribute to Canadian customers to fulfill authority requirements
  • Discuss the global regulatory landscape for CRT products and where they may get flagged


Presentation by:

Tonino Antonetti, M.Sc., Executive Director, Regulatory Affairs & Quality Management -SHE, Roche Diagnostics

Rafik H. Bishara, Ph.D., Technical Advisor & Former Director QKMTS, Eli Lilly and Company (retired)


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