Bekki Komas is Director of Chemistry, Manufacturing and Controls, Regulatory Affairs Advocacy and Intelligence at GlaxoSmithKline, Research Triangle Park, NC. She received her degree from North Carolina State University in 1980. For five years she was employed by Cutter Laboratories a division of Bayer with responsibility for the stability programs for plasma products. She has been employed by GlaxoSmithKline for twenty four years. Her initial job responsibility included management of the analytical laboratories including stability testing of GSK products including tablets, topical, syrups, injections, powders and inhalers. She has over fifteen years experience in CMC Regulatory Affairs providing strategic CMC direction for worldwide marketing applications including leadership of Agency meetings and support for inspections. In the last five years, as Director of CMC Advocacy and Intelligence Bekki has been involved with Quality by Design Applications and involvement in Emerging Market Regulations and Influencing. As the Director of Advocacy and Intelligence she has become very experienced with global requirements and is active in AAPS, DIA CMC Regulatory Affairs and Regulatory Intelligence SIAC Working Groups and co-chair of ISPE Communities of Practice for Asia Pacific and Latin America.