March 2011 Issue
The annual spring tradeshow has reenergized itself by building a year-round online presence.
Maxiom Groups Scott Dicks answers our questions about whether drug manufacturers are moving ahead with electronic pedigree programs.
John Danese, Oracles Director of Product Strategy, provides an update on the electronic pedigree landscape and how manufacturers are doing in their serialization efforts.
Manufacturers electronic pedigree and serialization efforts creep ahead, slowed by FDAs inaction.
Has the industry been on the road to Oz? Didnt we already have what we needed in the GMP code and good engineering principles?
A lot of the walking weve done should now allow us to run, or fly.
FDA, where is the guidance? If you dont issue some, Big Pharma will.
Before arguing about Just in Time (JIT) solutions and how to define them, shouldnt we look at why we need them, and form a plan?
Make critical decisions early, and get all the right people involved.
Organizations which adopt and implement a comprehensive supplier risk monitoring program will have visibility into a broad spectrum of overall supplier risk factors, not just compliance.
As paradigms shift, we also need paradigm expansion.
Respond fully to allegations, experts say; if youre considering blowing the whistle, be sure the noncompliance is serious enough to threaten product integrity.