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Quality Systems and the Medical Product Review Process

Explore the importance of instituting continuous improvement and quality systems in premarket and production scale activities for medical product reviews, ensuring consistent quality in mass production. Learn about the key components of quality systems and how to integrate evolving science into the review process.

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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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