Betsy Fritschel Johnson & Johnson

Betsy Fritschel is Director at Johnson & Johnson Enterprise Regulatory Compliance, a corporate group which provides quality and GMP regulatory support to J&J Operating Companies. Betsy joined Johnson & Johnson in 1981 as an analytical chemist, and has extensive pharmaceutical experience in the QC lab environment, manufacturing site quality, and corporate quality oversight. Her main expertise includes quality & compliance for J&J’s API manufacturing. Her current role is focused on intelligence and information-sharing across the global J&J network in the areas of GMP and regulatory compliance. She is also currently leading the J&J team working on Quality Metrics.

Betsy has represented PhRMA in ICH since 1998. She is currently a member of the ICH Implementation Working Group (IWG) for Q11 that is developing clarifying Q&A for Starting Material. She has also been the PhRMA lead on the IWG that is currently finalizing clarifying Q&A for ICH Q7 Active Pharmaceutical Ingredient Good Manufacturing Practices. She has spoken as an invited lecturer at the PDA PIC/S training on GMP for APIs several time including the US and Belgium in 2014 and Brazil in 2015. She was a member of the original ICH Q7 EWG, and participated in the development and presentation of Q7 training for industry and regulators in both US and Europe. Betsy received the FDA Commissioner’s Special Citation in 2004 for her work on Q7. She was also a member of recently concluded Expert Working Group for the International Conference of Harmonization (ICH) Q11 Development and Manufacture of Drug Substances.