# Presentation: 494021

## 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?

## 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

## Review Process:  Production Scale Activities

- New Drugs--
- Annual # scientific reviews:  21, 217
- Annual # letters issued:  2,500
- Generics
- Annual # scientific reviews:  5,000

## 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

## 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

## Ensuring Consistent Quality in Mass Production: Evolution

- Standardization
- Quality control
- Quality assurance
- Quality systems
- Quality management

## Quality Systems

- Say what you do
- Do what you say
- Prove it
- Improve it

## Say what you do

- 		Identify Customers
-        	State Vision and Purpose
-        Define Quality
-        Define Quality Attributes
-        Define Process

## Do what you say

- Quality Attributes   Specifications
-                               Standards
-                               Quality control
- Process management
-                                Define process
-                                Standardize
-                                Track
-                                Control process

## Prove it

- Customer satisfaction
- Quality attributes level--trend analysis and metrics
- Process level--Audits and evaluation

## Improve it

- “Corrective and Preventive Actions
- Feedback and training
- Organizational learning

## But, review is an intellectual activity...

- ...the review product is a scientific document...

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

## 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

## 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

## Questions for committee

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