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The Quality System (QS) Train is Moving Fast at FDA. Lana L. Pauls, MPH Director, Quality Management Staff CDER/FDA. Learning Objectives At the conclusion of this session, participants should be able to:. Summarize the basic concepts of a quality system
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The Quality System (QS) Train is Moving Fast at FDA Lana L. Pauls, MPH Director, Quality Management Staff CDER/FDA
Learning ObjectivesAt the conclusion of this session, participants should be able to: • Summarize the basic concepts of a quality system • Describe the basic areas that FDA is implementing a QS • Discuss the detailed progress that FDA has made in regard to using a QS in three specific areas: • CBER • CDER/CBER - QMS for CMC • CDER - QMS impact on drug safety
What is a Quality System? • In a nutshell . . . • Say what you do • Do what you say • Prove it • Improve it
Why a QS? • Helps organize workflow • Helps prioritize resources • Minimizes employee frustration • Minimizes Industry frustration • Has been expected of Industry for many years • It just makes sense!
Why Now? • PDUFA 3 Mandate • In the FDA strategic plan
What Has Happened? • QS Framework developed in 2004 • SMG 2020 being used broadly across FDA (albeit slowly) • FDA Quality Resource and Guidance Team (QRGT) • Agency-level group of quality experts that provides: • resource materials and guidance • recommendations to the Management Council • Agency-wide implementation plans and communications
Scope of QS Implementation at FDA (1) • Regulatory laboratory accreditation • CGMP initiative: • Recalls of pharmaceutical product • Warning letters related to CGMP issues • FDA pharmaceutical inspectorate • Process analytical technology (PAT) team • Team Biologics quality program
Scope of QS Implementation at FDA (2) • Innovations in medicine: • Pre-approval review • Bioresearch monitoring (BIMO) • FDA Office of Management • IT Enterprise Architecture • PDUFA III Business/IT Governance
PDUFA 3 QS Contracts • PDUFA 3 set aside for “Performance Excellence” • Nine contracts awarded to date • Postmarketing Commitments • Meeting Minutes • OND Process Improvement • OCPB Process Improvement • Quality System for CMC • OSE Process Improvement • Managerial costing (completed) • Evaluation of DSOB • Quality system training (completed)
Presenters Deborah Jansen • “What Do You Mean When You Say Quality System: A CBER Perspective” Jon Clark Lana Pauls • “QMS: The Impact on the Drug Safety Process”