the quality system (qs) train is moving fast at fda lana l. pauls, mph director, quality management...
Post on 18-Dec-2015
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TRANSCRIPT
The Quality System (QS) Train is Moving Fast at FDA
Lana L. Pauls, MPHDirector, Quality Management Staff
CDER/FDA
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Learning Objectives At the conclusion of this session, participants should be able to: 1. Summarize the basic concepts of a quality
system2. Describe the basic areas that FDA is
implementing a QS3. Discuss the detailed progress that FDA has
made in regard to using a QS in three specific areas:
1. CBER2. CDER/CBER - QMS for CMC3. 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)
1. Regulatory laboratory accreditation
2. CGMP initiative:a. Recalls of pharmaceutical product
b. Warning letters related to CGMP issues
c. FDA pharmaceutical inspectorate
d. Process analytical technology (PAT) team
e. Team Biologics quality program
Scope of QS Implementation at FDA (2)
3. Innovations in medicine:a. Pre-approval review
b. Bioresearch monitoring (BIMO)
4. FDA Office of Managementa. IT Enterprise Architecture
b. PDUFA III Business/IT Governance
PDUFA 3 QS Contracts
• PDUFA 3 set aside for “Performance Excellence”
– Nine contracts awarded to date1. Postmarketing Commitments2. Meeting Minutes3. OND Process Improvement4. OCPB Process Improvement5. Quality System for CMC6. OSE Process Improvement7. Managerial costing (completed)8. Evaluation of DSOB9. Quality system training (completed)
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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”