Navigating FDA Standards, Quality Systems & Inspection Readiness

Register via the RAPS website: https://www.raps.org/learn-develop/events/san-francisco-bay-area-chapter-in-person-event-quality-and-regulatory-summit-navigating-fda-standards-quality-systems-inspection-readiness-across-medical-devices-and-biopharmaceuticals.html

​Registration via Eventbrite alone will not be considered as a valid pass. A ticket obtained via RAPS is required for event entry

​FDA expectations continue to evolve across medical devices, drugs, biologics and combination products. For CMC, Quality, Regulatory Affairs, Manufacturing and Compliance professionals, understanding how standards, quality systems and inspection expectations connect is essential to building effective development and manufacturing programs.

​This program brings together FDA representatives, industry leaders, testing laboratories and former FDA professionals for a practical discussion spanning the product lifecycle.

​The program is structured around three questions:

1. ​What evidence does FDA rely on?
   Explore FDA-recognized consensus standards, conformity assessment, the ASCA program roadshow, testing laboratories and the role of reliable quality evidence in regulatory decision-making.
2. ​How do companies build systems that consistently generate that evidence?
   Examine how companies establish sustainable quality systems across medical devices, drugs, biologics and combination products. Topics include QMSR, ISO 13485, MDSAP, 21 CFR Part 4, CAPA, change management, risk-based quality management, manufacturing controls and lifecycle management.
3. ​How does FDA verify those systems during an inspection?
   Hear directly from FDA inspection professionals about inspection approaches, investigator expectations, common observations, inspection readiness and compliance considerations across medical devices, drugs and biologics. This session will include a hands-on workshop based on an industry case study

​The full-day event will combine expert presentations with moderated discussion, workshop and audience Q&A, giving attendees an opportunity to engage directly with FDA and industry speakers.