Performance Verification Testing in Dissolution

Solving Problems That Matter - a Waters webinar series featuring USP speakers

Episode 10: Performance Verification Testing in Dissolution

Presenter: Naiffer Romero, MSc, MPH (Principal Scientist - Scientific Affairs, US Pharmacopeia)

Naiffer has more than 20 years of pharmaceutical industry experience. In his 13+ years tenure with USP, he has served several roles: Lead scientist in the dosage form performance laboratory, reference standard development team, Manager in charge of LATAM Compendial engagement and education, responsible for stakeholders and national regulatory bodies engagement. Naiffer is also a certified USP Education instructor. Most recently, Naiffer joined USP's Scientific Affairs performance cell, where he leads scientific outreach and engagement for LATAM & U.S. on key national health priority topics. His combined pharmaceutical expertise includes Analytical Development, salt and polymorph selection, Development of dissolution methods, IVIVC modeling, and impurity analytical strategy. Naiffer also serves as a member of USP's Nitrosamine Steering Committee and community host to 'Nitrosamine Exchange,' a knowledge community in All-things Nitrosamine. Naiffer also liaises technical discussion on pharmacopeial collaboration, including international meetings of World Pharmacopeias (part of WHO).

Moderator: Isabelle Vu Trieu (Pharmaceutical Market Development Manager, Americas, Waters Corporation)

Isabelle is a business development professional dedicated to delivering benefits to analytical scientists in the life sciences industry. With over 20 years of experience in providing chromatography and mass spectrometry solutions, Isabelle is particularly interested in helping pharmaceutical scientists achieve the data quality and integrity needed to drive decisions for drug quality, safety and efficacy. Isabelle joined Waters in 2009 and currently manages the development of the pharmaceutical market in the Americas. She holds Masters’ degrees in Chemistry from Columbia University and the University Claude Bernard in Lyon, France as well as a Chemical Engineering degree from Ecole Supérieure de Chimie Physique Electronique in Lyon, France.