November/December 2012 Issue
A brief summary of best practices.
As operations become more complex, even small improvements in efficiency can translate into huge savings
Dont mistake the Quality Management module of your ERP for a quality management solution. Each has its distinct advantages
Catalent worked within the QbD framework to help a customer transfer a new blow-fill-seal (BFS) process.
Is the risk of operating unsafely ever worth the short-term reward?
FDAs hard pressed to inspect offshore facilities; now it also faces compounders and other domestic challenges.
Academic study finds companies can use social media not only to collect consumer feedback, but also to alert FDA to drug problems and reactions.
A look at recent FDA enforcement activities and lessons to be learned.
A quick check of the fundamentals will help you approach manufacturing analytics with the right statistical mindset.
Once you know what the objective is and what the need is, you can figure out which tools can help meet your objectives
Watch out. Asian pharma professionals are serious about learning how to do PAT and QbD