WebbDr Ramesh Raghavachari, FDA, USA Objectives The ICH Q12 topic was endorsed by the ICH Steering Committee in September 2014 and the draft ICH Q12 Guideline on Technical … 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, and expectations of FDA drug manufacturing ...
Regulatory Best Practices for Global Access to Medicines
Webb23 nov. 2024 · Dr Ramesh Raghavachari, FDA. Zielsetzung. ICH Q8 / ICH Q11. You will be updated on the latest regulatory developments and learn how to apply the respective paradigms in Pharmaceutical Development to be better able to design strategies for the implementation of Quality by Design ... Webb2 maj 2024 · A main challenge for biopharmaceutical manufacturers is to incorporate engineering and design controls for medical devices into quality-based design strategies for a drug or biologic. Policy makers have responded with legislation that streamlines FDA oversight of combination products, while the pending FDA-industry agreement on drug … hrr architecture
Ramesh Raghavachari FDA - SUPERVISORY CHEMIST FDAzilla
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 … 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., WebbRamesh Raghavachari, Chief Branch I Division of Post-Marketing Activities I OLDP OPQ CDER Post-approval Considerations for Changes to Manufacturing Process and Facilities hrr army medchart