Direct Access to Quality Manufacturing Experts

I worked in other industries earlier in my career but when I made my connection to medicine (biotechnology, pharmaceuticals, and medical devices), I quickly recognized our industry’s impact on improving and extending lives, which gave me an enormous sense of purpose - and I was hooked. My attendance at ISPE conferences has been instrumental in my continual GXP/industry education and in forging a significant professional network. I believe the talent and collective potential of the industry is greater than ever before and fosters innovation through collaboration. This is the perspective I brought to the role of co-chair of the 2016 ISPE/PQRI/FDA Quality Manufacturing Conference. 

I wanted to gather the very best quality manufacturing experts from our industry to create a forum for the most significant industry topics. As I step back to view the program, what stands out for me is that the patient is central to each session and event at this year’s ISPE/PQRI/FDA Quality Manufacturing Conference. In the first session, Dr. Yoram Unguru MD, an oncologist at the Children’s Hospital at Sinai in Baltimore and a faculty member at the Berman Institute of Bioethics at Johns Hopkins University, will present “When Drugs are Short, but the Ethical Challenges are Long: The Absurdity of Having to Choose which Children Receive Scarce Life-saving Chemotherapy”. 

Dr. Unguru is a drug shortage champion and his passion is truly inspiring. The educational sessions which are organized in three tracks have been designed to promote new ideas and drive collaboration to enable our industry to build on the successful application of manufacturing and operational excellence, to drive the transformation of Quality oversight, and to challenge existing paradigms to meet the changing needs of the patients we are privileged to serve. One of the most beneficial aspects of an ISPE conference is the direct access to the regulatory and industry quality manufacturing experts.  You can benefit the most from the conference by actively engaging in the educational sessions and the Quality Metrics update, panel discussion and the Industry Regulatory Discussion Forum on the final day. I hope to see you in Bethesda June 6-8.