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The 7 Pillar Rules are advancing into the final stretch. The FDA will have their action plan ready to implement in 2015-2016. Essentially, the gavel will hit the sounding block before the next Presidential election, or at the time the court-imposed deadlines approach.
By Ray Caron
Author: Ray Caron
Ray joined DeltaTrak in 2010 as Marketing Manager and currently holds the position of Senior Vice President of Marketing, Business Development and Chief Operating Officer of DataMark Inc.
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Today there is an ever growing trend toward Cloud Computing, with many companies entrusting their data to an outsourced agency. As we approach the New Year, it seems like a good time to review all areas of your supply chain where risks might exist, and to mitigate these issues with risk aversion planning that will meet GDP compliance.
By Peter Norton
Author: Peter Norton
Peter Norton is a senior logistics and supply chain manager and consultant to the life science industry, with extensive experience in both the domestic US and global markets.
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Like many of us that work in this industry I always follow very closely the presentations from the Spring and early Summer rounds of trade events and industry meetings to see what might be new.
Being that cold chain and drug security are close to my own areas of personal interest I always tune in on the articles and data related to these two areas.
Last Wednesday (March 12th) we held our webinar related to new and global supply chain regulations and Risk Assessment and Risk Planning. This webinar was well attended and the majority of those individuals that had registered did attend and listened to the webinar.
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.
In March of 2013 in the EU the EMA introduced a new guideline related to Good Distribution Practices (GDP) and in June of 2013 the Chinese FDA introduced a new guideline related to Good Supply Practices (GSP).