In a recent Blog post I discussed two recent regulations that were introduced last year, one for GDP (Good Distribution Practices) within the EU and one for GSP (Good Supply Practices) within China.
Both of these regulations are very similar in content and biased towards securing the supply chain, by requiring adoption of methodologies to prevent falsified medicines from entering the supply chain and also requiring a fully documented Risk Assessment Process/Plan coupled with a fully documented Risk Mitigation plan all as part of any company's QMS (Quality Management System).
Most probably the majority of pharmaceutical and biologics companies have a very good, or a through, understanding of the risk areas within their supply chain and cold chain logistics operation, however, with many ongoing regulation changes and a multitude of different shipping lanes, carriers, or transport methods, risk is always present and frequently changing.
To help with understanding these new regulations and the evolution of many new global regulations focused towards Risk Management as part of a Quality Management System, I will be hosting a webinar on the subject of Cold Chain Risk Aversion Planning to guide the attendees through risk area evaluation within any supply chain, or cold chain process, and how to establish a Risk Mitigation plan. I am sure that many attendees will be well aware of where or what type of risks may exist within their distribution networks , but I am hopeful that I will address some areas or types of risk areas you may not have considered before.