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Inaugural meeting at PDA/FDA joint regulatory conference Washington, D.C. September 28th
September 15, 2015
By: Tim Wright
ValSource’s senior director of consulting, Michael Long, has been named to lead the Parenteral Drug Association’s (PDA) new Applied Statistics Interest Group, which is concerned with the creation, development and manufacture of pharmaceutical products using statistical tools from starting materials to finished product. From development through manufacture and end of use, its focus encompasses the entire lifecycle and seeks to improve the understanding of issues for applied statistics within the scientific, technical and pharmaceutical community, while providing an environment where PDA membership has a resource to explore and understand tools being employed by experienced users. Dr. Long directs ValSource’s process validation method development. He is the former co-leader of the PDA Quality Risk Management Interest Group and a two-term science advisory board member. “These are truly exciting times for our industry,” said Dr. Long. “The work of this group is certain to have far-reaching implications as we push our internationally-based membership in order to foster a harmonized vision of applied statistics.” The Applied Statistics Interest Group has planned two engaging industry talks addressing Process Capability and Quality Metrics, to take place at the PDA/FDA Joint Regulatory Conference in Washington, D.C., September 28th.
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