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.
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 was the PhRMA lead on the IWG that developed clarifying Q&A for ICH Q7 Active Pharmaceutical Ingredient Good Manufacturing Practices that were published earlier this year. She is a member of the ISPE Quality Metrics Core Team and is leading the cross-functional team at J&J that is preparing for the new expectations regarding submission of data to FDA for calculation of Quality Metrics.