Live Chat Software
October 15 - 18, 2019
Seaport Boston, MA

Rafik Bishara , Ph.D.

Technical Advisor & Former Director QKMTS
Eli Lilly & Company

1:50 PM Preparing your Supply for the Regulatory Provisions Outlined in Health Canada Guide-00069 from Frozen to CRT

Tony and Rafik will discuss the Health Canada Guide-00069 regulations and requirements in Canada and provide detailed examples 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 more often

Check out the incredible speaker line-up to see who will be joining Rafik.

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