The Pharmaceutical Quality (PQ) Community will hold its first meeting on Friday, May 29, 2026, from 2:00–2:55 PM EST. Our goal is simple: bring together scientists and quality professionals to exchange practical insights, discuss current challenges, ...
Be part of an exciting initiative exploring how AI/ML can transform product quality. This team will serve as a platform to exchange ideas, discuss challenges, and highlight practical applications in monitoring and improving quality across the lifecycle. ...
Join us in building a collaborative scientific team focused on pharmaceutical product specifications. This group will create a forum to discuss real-world challenges, evolving regulatory expectations, and practical approaches across the lifecycle. Our ...
Hosted by the AAPS NAM Subcommittee, NAM Working Group, and Regulatory Science Community (Gene and Cell Therapy Product team) The AAPS NAM Subcommittee, NAM Working Group, and Regulatory Science Community are convening an Open Scientific ...
Draft guideline was issued and comments must be submitted to FDA by 6/22/2026. Let us know if anyone is interested to provide comments. Establishing Impurity Specifications for Antibiotics | FDA ------------------------------ Kim Huynh-Ba, MS, ...
Welcome Message We are honored to serve as Chair and Vice Chair of this Pharmaceutical Quality Community (PQC) and are excited to build a dynamic, supportive, and forward-looking network together. Our mission goes beyond compliance-we are here to ...
Federal Register :: Recommendations on Scale-Up and Postapproval Changes Guidances for Industry; Request ...