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.
When any QA department turns their attention to data and security most of the focus is on how this is controlled internally in relation to common regulations like - 21 CFR Part11, Part 820, GMP, etc., and of course patient data regulations like HIPAA.
On November 27th of 2013 when President Obama signed into law the HR3204 - the Drug Quality and Security Act, it was the result of many years of discussion and past attempts to establish a US centric law based upon securing the drug supply chain in an effort to prevent the entry of falsified medicinal products into the supply chain.
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