Webb18 juni 2024 · Ramesh Raghavachari, PhD Understanding Regulatory Expectations for Drug Device Products in the EU Janine Jamieson, PhD, MPharm Challenges in the Dossier Presentation of Combination Product Control Strategy: Integration of QbD and Design Control Deborah M. Schachter, PhD, MBA. Webb25 aug. 2024 · Hasmukh B. Patel, Ramesh Raghavachari and Rose Xu 3:00 – 3:50 FDA Drug Manufacturing Inspections This presentation will discuss the purposes, conduct, …
DIA 2024 Virtual Global Annual Meeting: Directory
WebbDr Ramesh Raghavachari, FDA, USA Zielsetzung The ICH Q12 topic was endorsed by the ICH Steering Committee in September 2014 and the draft ICH Q12 Guideline on Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management was published for comment in December 2024. WebbTOPIC: FDA’s Assessment of Quality of Drug APIs and Drug Products 9:20 A.M Desmond Hunt, Ph.D., M.S., Senior Scientific Liaison, United States Pharmacopeia, Rockville, MD TOPIC: USP and Emerging Expectations for Extractables and Leachables for Container Closure Systems 10:10 A.M Refreshment Break 10:40 A.M. Tao Wang, Ph.D., roger rabbit betty boop
NDA 204630/S-018 Page 3 - Food and Drug Administration
WebbRamesh Raghavachari, Chief Branch I Division of Post-Marketing Activities I OLDP OPQ CDER Post-approval Considerations for Changes to Manufacturing Process and Facilities WebbRamesh Raghavachari, SUPERVISORY CHEMIST, works for the FDA. Call 301-796-1738. Email inside. 844.332.3320; Login; Solutions . Solutions. The FDAzilla family of products unlocks ... Ramesh Raghavachari SUPERVISORY CHEMIST 301-796-1738 send email. Looking for FDA investigators? DHHS/FDA/CDER/OMPT/CDER ... WebbRamesh Raghavachari, Ph.D. Chief, Branch I Division of Post-Marketing Activities I Office of Lifecycle Drug Products Office of Pharmaceutical Quality Center for Drug Evaluation and … our lady of lourdes decatur il