Wouldn't it be nice to know how to deal with and PREVENT audits?

It's not a surprise that regulations drive company strategies and the solutions/processes they implement. The pharmaceutical supply chain may be unique with the number of regulations that need to be followed, depending on where, how, and what you are shipping.

If you are going through the Canadian distribution networks, you need to have a complete understanding of Health Canada's Regulation 0069 and what it entails. However, Health Canada is due to release updates to their guidance in early 2011. The focus of these changes is to strengthen control in an end-to-end cold chain.

We're really excited that Sarah Skuce, Compliance Specialist at Health Canada will be reviewing the updates to GUI-0069 during the 9th Cold Chain & Temperature Management Summit in February in Toronto. Also, for the first time ever, Sarah will lead a pre-conference workshop to help the bio-pharmaceutical industry understand these changes. This will be a great opportunity to finally sit down with Health Canada and dissect actual case studies of inspections, audits and overcome their temperature control challenges!

More info about this workshop and presentation is available on our website.

Also, Sarah provided us with an article on Health Canada’s Guidelines for Temperature Control of Drug Products during Storage and Transportation