Cloud Computing? Keep Your Head Out of the Clouds by Making Sure your Data is GxP Compliant

When most people hear of Amazon.com, they think of one of the largest online marketplaces for consumer products.  What people may not realize is that Amazon is also one of the largest providers for computer power for cloud computing through their subsidiary Amazon Web Services (AWS).  Running applications in the cloud is a relatively new concept for many industries,

2015 ISPE Annual Meeting

Fran Zipp, President of Lachman Consultants, presented at the 2015 ISPE Annual Meeting, November 8-11 at the Philadelphia Marriott Downtown. She spoke about the launch of the ISPE Drug Shortage Assessment and Prevention Tool, on Monday, November 9 at 10:45 AM. For a preview of the tool, please see this article authored by Fran in November’s issue of Pharmaceutical Engineering.

Six Degrees of Shortage Prevention: ISPE Debuts New Gap Analysis Tool

Serving as a member of the pharmaceutical industry is a privilege that brings with it significant personal responsibility. In recent years, preventing and mitigating drug shortages has become a critical concern for every pharmaceutical professional. ISPE is leading an international effort to understand, assess, and educate patients, providers, regulators, and manufacturers on this critical topic.

FDA to Publish ALL Comments Submitted by Individuals to Dockets on Regulations.gov

Well, as someone who routinely reviews regulations.gov postings from the FDA, this comes as a bit of a surprise, because on some docket items there are literally thousands of comments to sift through.  Turns out that a pre-publication Federal Register notice (here) released today indicated that, back in 2007 when FDA merged its postings to regulations.gov,

FDA Aims to Secure Photo Rights Under FDASIA

The FDA’s assertion that it has the authority to take photographs during on-site inspections, as clarified in recently issued draft guidance, is coming under challenge by drug industry counsel. The agency constitutes refusal