medical device update gmp initiatives - the global...

Medical Device Update &

GMP initiatives

Karen A. ColemanNational Expert Devices

January 2004

Topics

• Quality System Regulation Inspection Issues

• Accredited Persons Inspection Program

• Device Certification Update

QSITQSIT

Quality System Inspection Issues

Turbo Cite Cross Reference• 3130 = 820.100 (a)• 4189 = 820.198 (a)• 630 = 803.17• 3696 = 820.100 (b)• 3415 = 820.22• 546 = 820.75 (a)• 4058 = 820.20• 2327 = 820.22• 3291 = 820.100 (b)• 3103 = 820.30 (i)

• Implementation of Corrective & Preventive Action Procedures [CAPA]

• Complaint Handling Procedures• Written MDR Procedures

• CAPA activities not documented

• Quality Audits• Process Validation

• Management with executive responsibility

• Procedures for Quality Audits• Problems with procedures for

documenting CAPA activities• Design Change Procedures

0

20

40

60

80

100

FY'03 Warning LettersM a mmo g r a p h y

G M P ' s

C l i n i c a lI n v / I R B ' s

M D R ' s

P e r f S t d s

P r e - ma r k e tN o t i f

I D E ' s

P r e - ma r k e tA p p r o v a l

M i s b r a n d e d

U n a p p r o v e dU s e

205 WL as of 12/31/2003

FY 03 Inspection Characteristics

8 19

190

23

-25

25

75

125

175

225

Percentage

Follow-UpInspections

InitialInspections

RoutineInspections

MDR Cite

Inspection Characteristics

Sample Size=261

Est. Total QS/GMPEIs=1,493

FY 2003 Device Characteristics

15

40

15

5

27

33

25

0 10 20 30 40 50 60 70 80Percentage

Unclassified

Class III

Class II

Class I

Trackable Device

Sterile Device

MDR Risk Factor

Significant Risk

Device Characteristics

Sample Size=261

Est. Total QS/GMP EIs=1,493

59

FY 03 Population Characteristics by District Decision

OAI 18%

VAI57%

Sample Size=261

Est. Total QS/GMP EIs=1,493

NAI25%

FY 2003QS/GMP Deficiencies

(483’s Issued)

181919

212123

2424

25

2637

4456

0 10 20 30 40 50 60 70

Percentage

Design Changes

Training

Document Control

Validation

Design Validation

Quality Sys. Mgmt

Audits

Design&Dev.Plan

DHR

Insp./Test Proc.

Nonconforming

Complaints

CAPA

Deficiency AreaSample Size=208

Est. Total QS/GMP EIs with 483’s Issued=712

Accredited Persons Inspection Program

Timeline Accredited Persons [AP] Inspection Program

10/26/02 – MDUFMA signed into law4/28/03 – AP Inspection program guidance8/25/03 - AP Applications due10/25/03 – Top 15 AP’s listed1/12/04 – FDA AP Training4/28/04 – New AP applications accepted

AP Inspection Web Site Topics• Accredited Persons Inspection Program

OverviewManufacturer EligibilityHow to Request an Inspection by an APFDA Denial of Request To Use an APRe-Establishing EligibilityLimits to the Number of AP Inspections That Can Be PerformedList of Accredited Persons

AP Web References

• http://www.fda.gov/cdrh/ap-inspection/ap-inspection.html

• http://www.fda.gov/cdrh/mdufma/aprating.html

• http://www.fda.gov/cdrh/thirdparty/thirdparty-how.html

Device Certification Update


What Are We Doing ?

Call for New Audit Candidates

December 2003 Performance Auditor Training Course

Device Certification UpdateWhere Are We Now?

20 out of original 52 remain

9 Left the Agency6 Retired15 Changed Jobs within FDA

16 New Auditors

Total = 36 Device Auditors

F

D

A


Work For the Auditors

• Domestic Audits

• MRA Program

• AP Program135 Audits

medical device update gmp initiatives - the global...

Documents