ISPE Packaging Validation Discussion Paper

ISPE Packaging Validation Discussion Paper

By Erica Stolz The International Society for Pharmaceutical Engineering (ISPE) recently published a new Packaging Validation Discussion Paper.  The paper is intended to help bridge a gap spanning between manufacturing process validation and packaging process...
4 Steps to Successful FDA Change Management

4 Steps to Successful FDA Change Management

By Vonda Ashley Change management is one of the key elements to a quality system in the pharmaceutical industry. Most pharmaceutical companies understand the need and purpose for change management as an overall concept and have a system(s) already in place to manage...