Generic Pharma Association CMC Workshop
May 23, 2017 to May 24, 2017
Bethesda North Marriott Hotel and Conference Center
North Bethesda, MD
GPhA is pleased to announce that its 2017 two-day CMC Workshop will be held on May 23rd and 24th in Bethesda, MD. This workshop will help you develop an in-depth understanding of various topics such as FDA’s current CMC expectations for ANDAs, the Office of Pharmaceutical Quality’s (OPQ) current thinking regarding facility assessments, and up-to-date expectations on the FDA’s quality standards as OPQ moves towards "One Quality Voice".
Attend this interactive workshop and gain the knowledge you need to best navigate current CMC regulatory quality requirements as well as witness unique in depth discussions among industry leaders and key officials from OPQ and the Office of Generic Drugs (OGD). Several of the discussions will take a deeper dive into some of the key topics discussed in prior CMC Workshops to provide further insight into how industry can better manage the GDUFA landscape.