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Quality Systems and the Medical Product Review Process

Quality Systems and the Medical Product Review Process. Janet Woodcock MD Director, CDER, FDA. Improving Innovation in Medical Technology: Beyond 2002. Key Area: “Instituting a continuous improvement/quality systems approach throughout premarket review What do we mean by this?.

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Quality Systems and the Medical Product Review Process

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  1. Quality Systems and the Medical Product Review Process Janet Woodcock MD Director, CDER, FDA

  2. Improving Innovation in Medical Technology: Beyond 2002 • Key Area: “Instituting a continuous improvement/quality systems approach throughout premarket review • What do we mean by this?

  3. Premarket Activities • “a review”: scientific assessment of submitted documents and data, with conclusions about conformance to scientific, technical and regulatory standards • “a review document”: written documentation of above

  4. Review Process: Production Scale Activities • New Drugs-- • Annual # scientific reviews: 21, 217 • Annual # letters issued: 2,500 • Generics • Annual # scientific reviews: 5,000

  5. Review Process: mass production! • All must be scientifically correct, apply regulatory/scientific standards appropriately • Subject to intense stakeholder and legal scrutiny • Need to incorporate any new scientific findings or new regulatory guidance

  6. Assuring Quality of Scientific Activities • Traditional “craft” or “guild” approach-- hierarchical system of control • Serial checking by successive levels of expertise or management • 19th Century or earlier • Most successful for one of a kind products

  7. Ensuring Consistent Quality in Mass Production: Evolution • Standardization • Quality control • Quality assurance • Quality systems • Quality management

  8. Quality Systems • Say what you do • Do what you say • Prove it • Improve it

  9. Say what you do Identify Customers State Vision and Purpose Define Quality Define Quality Attributes Define Process

  10. Do what you say • Quality Attributes Specifications Standards Quality control • Process management Define process Standardize Track Control process

  11. Prove it • Customer satisfaction • Quality attributes level--trend analysis and metrics • Process level--Audits and evaluation

  12. Improve it • “Corrective and Preventive Actions • Feedback and training • Organizational learning

  13. But, review is an intellectual activity... …the review product is a scientific document...

  14. How can this be reconciled with a quality system framework originating in mass manufacturing?

  15. Systems approach works well for many processes • Being applied in health care, service delivery, administrative processing • Variety of tools and methods that can be selected for specific application • We are exploring examples of use in scientific activities

  16. CDER Situation • Considerable work completed on process management aspects (procedures, training, tracking) • Considerable work completed on work product standards (review templates) • Some work on quality assurance/feedback • Little on systems aspects such as peer discussion and assessment, CAPA, organizational learning, metrics

  17. Questions for committee • Next presenters--examples of progress and proposals • What steps are most important for integrating evolving science into review?

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