CAPA Gap Analysis: Tell Me Something I Don’t Know About CAPA!myqacoach.com/files/documents/2015-01-24-CAPA-Pres.pdf · CAPA gap analysis: Tell me something I don’t know about

CAPA gap analysis: Tell me something I

don’t know about CAPA!

10 February 2015

Prepared by Diane Kulisek 1

CAPA Gap Analysis: Tell Me Something I Don’t Know

About CAPA!

10 February 20151

Presented by Diane Kulisek for

Topics to be covered:

� FDA CAPA Tripwires

� CAPA Investigations

� Reviewing and Correcting a Non-conformity

� Verifying CAPA Implementation and Validating CAPA Effectiveness

� Risk Management for CAPA

� Tips for Writing CAPA Plans

10 February 2015 Presented by Diane Kulisek 2



10 February 2015


FDA CAPA Tripwires


CAPA Gap Analysis: Tell Me Something I Don’t Know About CAPA!

FDA CAPA Tripwires� The FDA has published data analysis in regard to Form 483 observations since 2003 and Warning Letter cites since 2004.

� In 2013, the FDA data indicated that CAPA issues have consistently been one of the top types of FDA observations or cites throughout the past decade.

� CAPA has consistently represented approximately 1/3 of all FDA Form 483 observations in FDA data analysis reports

� 88%, 127 out of 144 Warning Letters issued, in 2013, cited CAPA deficiencies.




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FDA Inspectional Observationsby QMS Subsystem

Source: http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-orgs/documents/document/ucm416501.pdf


CAPA Represented 31% of all 2013 FDA Inspectional Observations

FDA CAPA Tripwires (continued)



CY2004 – CY2013Warning Letters with QS Citations

2004 2005 2006 2007 2008 2009 2010 2011 2012 2013

# of WLs 113 97 79 74 98 77 89 122 164 144




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CY2013Warning Letters

QS Subsystem # ofWLs w/CitePercentage

(144 Total WLs)CAPA 127 88%P&PC 127 88%DES 91 63%DOC 77 53%

MGMT 71 49%




Observation (QS Regulation) # of Observ. Percent21 CFR 820.100(a)CAPA Procedures missing or inadequate.

355 33%

21 CFR 820.198(a)Complaint Procedures missing or inadequate; Complaint files not maintained or inadequately maintained.

280 26%

21 CFR 820.100(b)CAPA activities not documented or inadequately documented.

133 12%

21 CFR 820.90(a)Nonconforming product not controlled or inadequately controlled (procedures, evaluation, notification, documentation).

120 11%

21 CFR 820.198(c)Complaint Investigation not performed (without prior investigation for a similar complaint).

71 7%

21 CFR 820.198(e)Record of Complaint Investigation missing or inadequate.

34 3%

CAPA TOTAL : 993(of 1,085)

92%

Most Frequent 2013 CAPA Form 483 ObservationsFDA CAPA Tripwires (continued)



10 February 2015


General Source: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/default.htm


� Failure to establish and maintain procedures for implementing corrective and preventive action, as required by 21 CFR 820.100(a).

◦ For example, your firm’s CAPA procedure, as outlined in the quality manual document DRAFT L-001-2.12 Laatukäsikirja, Quality Manual Mega Electronics Ltd, does not include requirements for analyzing quality data in order to identify existing and potential causes of nonconforming products, or other quality problems.

Specific Source: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm381538.htm (first device WL of 2014)

FDA CAPA Tripwires (continued)Examples of Actual 2014 CAPA Warning Letter Citations



� Failure to maintain complaint files and to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a). For example:

◦ a. CAPA number C13004 documented (b)(4). Upon the FDA investigator’s request for the associated complaint

record, your firm’s Quality Engineer indicated that the issue directly went to CAPA and that there was no entry of the incident on the feedback log.

◦ b. Section 9.2 of document number L-002-2.5 Myynti ja markkinointkäsikijra, Quality Manual Mega Electronics Ltd

Sales and Marketing Manual, defines a complaint as a written, electronic, or oral communication that alleges deficiencies. However, section 9, Customer Feedback, of the same document does not instruct or refer to the

process to be followed for documenting oral complaints.

◦ c. According to section 9.3 of document number L-002-2.5 Myynti ja markkinointkäsikijra, Quality Manual Mega Electronics Ltd Sales and Marketing Manual, customer feedback is recorded on a (b)(4) form and a determination is

made whether the feedback is a complaint. However, the form does not contain an entry or criteria for complaints to be evaluated for Medical Device Reportability. Your firm’s Quality Manager indicated that such evaluation is

performed by the Quality Engineer and recorded on the CAPA form for the complaint if a CAPA is opened.

Specific Source: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm381538.htm (first device WL of 2014, cont’d.)

FDA CAPA Tripwires (continued)Examples of Actual 2014 CAPA Warning Letter Citations (Cont’d.)



10 February 2015


� Failure to establish and maintain procedures for corrective and preventive action, as required by 21 CFR 820.100(a). ◦ For example, your firm did not have corrective and preventive action procedures in place at the start of our inspection.

◦ During the course of the inspection, you provided Corrective/Preventive Action Procedure, Revision Level 001 to our investigator. We cannot verify this procedure has been implemented.


Specific Source: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm429201.htm (last device WL of 2014)


FDA CAPA Tripwires (continued)Examples of Actual 2014 CAPA Warning Letter Citations (Cont’d.)


� Failure to establish procedures for corrective and preventive action, as required by 21 CFR 820.100(a). For example:◦ Your firm’s Corrective Action procedures (Corrective Action System SOP-019 dated 11/15/2012 and Problem Reporting SOP-002 dated 11/15/2012) do not include:� a) Requirements to verify or validate corrective/preventative action as effective and they will not adversely affect the finished device.

� b) Definitions of preventative actions or how preventive actions will be controlled.

� We acknowledge receipt of your revised Corrective and Preventive Action SOP-008, however it is inadequate in that it fails to include key requirements identified under 21 CFR 820.100(a)(1). For example:◦ Your revised procedure does not include a requirement that appropriate statistical methodology shall be employed where necessary to detect recurring quality problems as required by 21 CFR 820.100(a)(1).


Specific Source: http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/ucm425532.htm (second to last device WL of 2014)


Examples of Actual 2014 CAPA Warning Letter Citations (Cont’d.)



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� Create a matrix

◦ Include details of requirements as stated within the applicable regulation subsections: � 21 CFR 820.90 (Nonconformances)

� 21 CFR 820.100 (CAPA)

� 21 CFR 820.198 (Complaints).

� Map the Gap

◦ Map your organization’s procedures and content, detail, to each applicable regulatory requirement (perform a gap analysis).

� Close the Gap

◦ If any requirement (gap) has not yet been addressed (mitigated) within the Quality Management System, do so immediately.

� CAPA CAPA

◦ If the gap is significant, open a CAPA to track progress.


AVOIDING FDA CAPA Form 483 Observations and Warning Letter Citations


� Create and use a checklist

◦ to perform internal audits of your quality systems that represents all of the requirements for the applicable regulation subsections.

� Use templates ◦ To document Nonconformances, Complaint Evaluations, Complaint investigations and CAPA’s.

◦ Hardcopy or electronic

� Compliant with 21 CFR Part 11 if electronic

� Use logs ◦ to track status ◦ for ease in retrieval of records


AVOIDING FDA CAPA Form 483 Observations and Warning Letter Citations (cont’d.)



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� Implement a software application ◦ Include validation and 21 CFR Part 11 compliance◦ To track, maintain and retrieve quality-related documents and records◦ For use in recurrence monitoring and trend analysis.

� Establish work level and strategic metrics◦ Examples: dashboards, scorecards, respectively◦ Establish metrics for key indicators:

� Timeliness, completeness, effectiveness� Of Nonconformance Controls, Complaint Investigations and CAPAs. � Update monthly.

� Send reports to Management and to Sources of Problems ◦ With notification by email at least monthly◦ Retain delivery receipts◦ Include data in Management Reviews (see special note on next slide).



� 21 CFR 820.100(a)(7) requires that relevant information on identified quality problems, as well as corrective and preventive actions, be submitted for management review, however:

� From the FDA Presentation by Joseph Tartal this past November, in regard to the Preamble on Management Review

“. . . Only certain information need be directed to management.The manufacturer’s procedures should clearly define the criteria to be followed todetermine what information will be considered “relevant” to the action takenand why. FDA emphasizes that it is always management’s responsibilityto ensure that all nonconformity issues are handled appropriately.”

� Source: � Refer to Federal Register Doc. No.: 96-25720 (more on this later); Part VII; Comment 164;

Source link: http://www.gpo.gov/fdsys/pkg/FR-1996-10-07/html/96-25720.htm


FDA CAPA Tripwires (continued)AVOIDING FDA CAPA Form 483 Observations and

Warning Letter Citations (cont’d.)



10 February 2015



� Monitor the FDA website for new Warning Letters citing CAPA and check for new types of cites or new interpretations of existing regulations

◦ Link to 2015 Warning Letters –http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/default.htm




� Subscribe to FDA eNews for new regulations or new interpretations of existing regulations, etc.; links:

◦ https://service.govdelivery.com/accounts/USFDA/subscriber/new?topic_id=USFDA_29 or

◦ https://public.govdelivery.com/accounts/USFDA/subscriber/new?preferences=true





10 February 2015



� Monitor the FDA Website for CAPA-related guidance information;

� Links:

◦ FDA Guidance Email Updates: https://service.govdelivery.com/accounts/USFDA/subscriber/new?topic_id=USFDA_29

◦ Search the new FDA Guidance Documents Database: http://www.fda.gov/RegulatoryInformation/Guidances/default.htm

◦ CAPA Guidance: (snapshot of the 10-point decision flowchart used by FDA Inspectors) http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm170612.htm




� There are some things about CAPA Quality System Requirements you may not have known, because they do not appear in the applicable 21 CFR Parts (including 21 CFR 820).

� These were included within the FDA Presentation by Joseph Tartal this past November, regarding CAPA Basics (more about that presentation in a moment)

� Source: ◦ Federal Register Volume 61, Number 195 (Monday, October 7, 1996); Rules and Regulations;

Pages 52602-52662; Federal Register Doc. No.: 96-25720; Part VII; Department of Health and Human Services; Food and Drug Administration; 21 CFR Parts 808, 812, and 820; Medical Devices; Current Good Manufacturing Practice (CGMP); Final Rule; Docket No. 90N-0172; RIN 0910-AA09; Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule; Quality System Regulation; effective June 1, 1997.

◦ http://www.gpo.gov/fdsys/pkg/FR-1996-10-07/html/96-25720.htm





10 February 2015



� Some things about CAPA Quality System Requirements you may not have known (cont’d)

� From the FDA Presentation by Joseph Tartal this past November, regarding the Preamble to Procedures:

◦ Procedures for implementing corrective and preventive action must providefor control and action to be taken on devices distributed, and those not yetdistributed, that are suspected of having potential nonconformities. (Ref: Federal Register Doc. No.: 96-25720; Part VII; Comment 158).

� Source: http://www.gpo.gov/fdsys/pkg/FR-1996-10-07/html/96-25720.htm




� CAPA Guidance: (snapshot of the 10-point decision flowchart used by FDA Inspectors): http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm170612.htm





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� Leverage Quality Data shared by the FDA about CAPA; recent links:

◦ 2013 –

http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-orgs/documents/document/ucm416501.pdf

◦ 2012 -http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHTransparency/UCM395850.pdf

◦ 2011 -http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHTransparency/UCM345510.pdf




� Participate in web-hosted FDA training on CAPA-related topics; link to first example: http://fda.yorkcast.com/webcast/play/c369da3174e945db99747267beeb2a551d?source=govdelivery&utm_medium=email&utm_source=govdelivery



For additional information, go to:http://www.fda.gov/Training/CDRHLearn/default.htm?source=govdelivery&utm_medium=email&utm_source=govdeliveryor contact:[email protected] call 1-800-638-2041.



10 February 2015



� Participate in web-hosted FDA training on CAPA-related topics; link to second example (Special Thanks to Pathwise (www.pathwise.com) for sharing the link!): http://fda.yorkcast.com/webcast/Play/c78cfebf72774163a59f8f6f197435451d



Link to the slide deck:http://www.fda.gov/downloads/Training/CDRHLearn/UCM421767.pdf

CAPA Investigations





10 February 2015


Best Practices in Managing CAPA Investigations

� From the FDA Presentation by Joseph Tartal this past November, in regard to the Preamble on Investigations:

� The requirement in this section is broader than the requirement forinvestigations under Sec. 820.198, because it requires that nonconforming product discovered before or after distribution be investigated to the degree commensurate with the significance and risk of the nonconformity.

� Source: � Refer to Federal Register Doc. No.: 96-25720; Part VII; Comment

161; Source link: http://www.gpo.gov/fdsys/pkg/FR-1996-10-07/html/96-

25720.htm


Best Practices in Managing CAPA Investigations (continued)

� Also from the FDA Presentation by Joseph Tartal, in regard to the Preamble on Investigations:

� The requirement in this section applies to process and qualitysystem nonconformities, as well as product nonconformities; example: if a molding process with its known capabilities has anormal 5 percent rejection rate and that rate rises to 10 percent, an investigation into the nonconformance of the process must be performed.

� Source: � Refer to Federal Register Doc. No.: 96-25720; Part VII; Comment 161;





10 February 2015


� Additional Investigation Considerations:

• Be careful of documenting brainstorming outcomes , with the potential for as many causes as can be thought of, on templates for cause identification such as Cause and Effect Diagrams, 8D or 5 Why, Multi-voting, Rank Order, etc. All causes must be addressed .

• Focus upon documenting verified causes with risk levels which require mitigation . More on CAPA risk management in a few moments.

• Because quality system nonconformities require CAPA investigations, internal audit observations must be investigated and, because the CAPA program is auditable, records of internal audit observations with CAPAs are auditable by the FDA



� Additional Investigation Considerations (cont’d.):• “No action required” investigation outcomes require careful technical rationale.

• Economic feasibility seems to be unacceptable as rationale.

• Claims of isolated incidents are also frowned upon and difficult to substantiate.

• “Tolerable Risk” which does not require mitigation is subjective and can be easily challenged as such.

• “User error” indicates that the Instructions for Use (IFU) are inadequate or that the device is not adequately labeled or not adequately designed to prevent “User error”.

• “Failed to follow procedure”, along with Indicating that an individual accountable for the nonconformity is no longer with the company (worst case) or has been re-trained (best case) places employee qualification, training and competency in question, leading to an in-depth review of training records, job descriptions and resumes used in the hiring and work assignment processes.





10 February 2015


Reviewing and Correctinga Non-conformity



Reviewing and Correcting a Non-conformity

� In addition to the regulatory requirements of 21 CFR 90 for addressing non-conformities:

• Verification of a Complaint does not constitute completion of a Complaint Investigation

• Correction of a nonconformity does not constitute corrective action.

• Recurrence control does not constitute Preventive Action

• Those authorized to perform and approve non-conformity reviews and/or render dispositions should not be the same people likely to have been directly accountable for causing the non-conformity.




10 February 2015


Reviewing and Correcting a Non-conformity (Continued)

� In addition to the regulatory requirements of 21 CFR 90 for addressing non-conformities (cont’d.):

• Affected inventory purges should be considered in association with nonconformity corrections.

• Inventory purges need to take into account items in fabrication, in transit and in other ‘off-the-shelf ’ or ‘off line’ locations, such as segregation bond areas.

• Recalls and other types of field actions are other possible correction elements.


� In addition to the regulatory requirements of 21 CFR 90 for addressing non-conformities (cont’d):

• Specify acceptable forms of product correction: typically: scrap, rework, or acceptance for “use as is”, with “return to vendor” as an alternative to scrap or rework.

• Note that rework processes require verification and validation to ensure appropriateness for intended purpose, including assessment of whether or not the rework process may unfavorably impact product efficacy.





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� In addition to the regulatory requirements of 21 CFR 90 for addressing non-conformities (cont’d.):

◦ “Use as is” dispositions have serious implications with regard to adequacy of originally specified requirements and may be perceived as specification deviations.

◦ Specification deviations or repair instructions will likely invalidate the processes and/or products affected and may require re-validation, as well as resubmission for regulatory evaluation.

◦ Verification of correction becomes part of the Device History Record.



Verifying CAPA Implementation and

Validating CAPA Effectiveness





10 February 2015


Verifying CAPA Implementation and Validating CAPA Effectiveness

� From the FDA Presentation by Joseph Tartal this past November, in regard to the Preamble on Verification and Validation:

� FDA has revised Sec. 820.100(a)(4) to reflect that preventive,as well as corrective,action must be verified orvalidated. Source: Preamble, Comment 163

� Source: � Refer to Federal Register Doc. No.: 96-25720; Part VII; Comment 163;



� 21 CFR 820.100(a)(5) requires that we “Implement and record changes in methods and procedures needed to correct and prevent identified quality problems”◦ Verifiable objective evidence of corrections implemented◦ Verifiable objective evidence of recurrence controls (corrective actions) implemented

◦ Validated objective evidence of non-recurrence or non-occurrence

� Subjective evidence may be converted to objective evidence through documentation of and consistent compliance with objective criteria for the outcome of subjective assessments





10 February 2015


• Consider use of Statistical Methodology (21 CFR820.100(a)(1)) whereby: “Appropriate statistical methodologyshall be employed where necessary to detect recurring qualityproblems”

• What is “appropriate” and what constitutes a “recurrence” are subjective.

• Try to find guidance or an example of a similar methodology having been previously applied and found acceptable

• If you cannot find an example from the FDA, try another government agency



Risk Management for CAPA





10 February 2015


Risk Management for CAPA ● Is the strategy of ranking CAPA problems to be addressed

from highest to lowest risk and mitigate risks in rank order adequate?● ALL quality problems must eventually be addressed ● ALL CAPAs musts be completed in a timely and effective manner

● Risk management of CAPA should not be confused with resource management● In all CAPA contexts, the risk being managed is that of impact upon

user or patient safety, not economic risk to the producer

● The lowest risk problem for one CAPA might be higher than the highest risk problem for another CAPA.● Risks within AND between CAPA efforts must be managed.


Risk Management for CAPA (continued)

� From the FDA Presentation by Joseph Tartal this past November, in regard to the Preamble on Risk and the Degree of Corrective and Preventive Action:

� The requirement in this section is broader than the requirement for investigations under 21 CFR 820.100, because it requires

“…the degree of corrective and preventive action taken to eliminate or minimize actual or potential nonconformities must be appropriate to the magnitude of the problem and commensurate with the risks encountered . ..”

� Source: � Refer to Federal Register Doc. No.: 96-25720; Part VII; Comment 159; Source link:

http://www.gpo.gov/fdsys/pkg/FR-1996-10-07/html/96-25720.htm




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● In 2011, the Government Accountability Office (GAO) found the FDA deficient with regard to CAPA-related risk management● Reference: GAO-11-556T “MEDICAL DEVICES: FDA’s Premarket Review

and Postmarket Safety Efforts”

● Source Link: http://www.gao.gov/new.items/d11556t.pdf



● From the 2011 Introduction to GAO-11-556T :

● Source Link: http://www.gao.gov/new.items/d11556t.pdf




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● CAPA Guidance from another government agency● Nuclear Regulatory Commission (NRC) - Attributes of an Effective Corrective Action Program (DRAFT)

● Source Link: http://pbadupws.nrc.gov/docs/ML1122/ML112241408.pdf

● Excerpt (Note: There are 6 paragraphs about Significance Assessment):



● Nuclear Regulatory Commission (NRC) - Attributes of an Effective Corrective Action Program (DRAFT)

● Source Link: http://pbadupws.nrc.gov/docs/ML1122/ML112241408.pdf

● Excerpt (Note: there are 4 paragraphs about Effectiveness Assessment):




10 February 2015


Tips for Writing CAPA Plans



Tips for Writing CAPA Plans


� Identify the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems (21 CFR 820.100(a)(3))



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� Per at least one FDA CAPA Subject Matter Expert (SME), CAPA Plans should include:

� Establishing Data Sources and Criteria� Measuring and Analysis of Data Sources� Improvement Plans� Input to Management

◦ Source: Corrective and Preventive Action Basics, prepared by Joseph Tartal, Postmarket and Consumer Branch Chief, Division of Industry and Consumer Education, Office of Communication and Education, Center for Devices and Radiological Health

◦ Link: http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/UCM377651.pdf

Tips for Writing CAPA Plans (continued)



� Excerpts from GHTF SG3, Global Harmonization Task Force, Study Group 3, “Quality Management System – Medical Devices – Guidance on Corrective and Preventive Action and Related QMS Processes”

◦ Link: http://www.imdrf.org/docs/ghtf/final/sg3/technical-docs/ghtf-sg3-n18-2010-qms-guidance-on-corrective-preventative-action-101104.pdf



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� Excerpts from GHTF SG3 (cont’d.)◦ Link: http://www.imdrf.org/docs/ghtf/final/sg3/technical-docs/ghtf-sg3-n18-2010-qms-

guidance-on-corrective-preventative-action-101104.pdf



� Excerpts from GHTF SG3 (cont’d.)




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� Excerpts from GHTF SG3 (cont’d.)


One Additional Tip for Documenting any Part of a CAPA Record


� Good Documentation Practice (GDocP) applies;

� Recommended website for additional information about GDocP, link: http://en.wikipedia.org/wiki/Good_Documentation_Practice◦ Wikipedia reference on GDocP includes links to

10 FDA Warning Letters and 1 Form 483, � Each indicates the applicable observations for GDocP

issues which led, at least in part, to the observations and cited nonconformities.



10 February 2015


Summary of Helpful CAPA Links


� 2013 FDA 483 and Warning Letter Data -

http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-afda-orgs/documents/document/ucm416501.pdf

� 2012 FDA 483 and Warning Letter Data -http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHTransparency/UCM395850.pdf

� 2011 FDA 483 and Warning Letter Data -http://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHTransparency/UCM345510.pdf

� Actual 2014 Warning Letters –

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2014/default.htm

� Actual 2015 Warning Letters –http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2015/default.htm

Summary of Helpful CAPA Links (Continued)


� Subscribe to FDA eNews

https://service.govdelivery.com/accounts/USFDA/subscriber/new?topic_id=USFDA_29 or

https://public.govdelivery.com/accounts/USFDA/subscriber/new?preferences=true

� FDA Guidance Email Updates https://service.govdelivery.com/accounts/USFDA/subscriber/new?topic_id=USFDA_29

� Search the new FDA Guidance Documents Database: http://www.fda.gov/RegulatoryInformation/Guidances/default.htm

� CAPA Guidance for FDA Inspectors

http://www.fda.gov/ICECI/Inspections/InspectionGuides/ucm170612.htm

� FDA Presentation by Joseph Tartalhttp://www.fda.gov/downloads/Training/CDRHLearn/UCM421767.pdf

� Good Documentation Practice (GDocP) http://en.wikipedia.org/wiki/Good_Documentation_Practice



10 February 2015




� CDRH Industry Basics Webinar featuring a section on CAPA

http://fda.yorkcast.com/webcast/play/c369da3174e945db99747267beeb2a551d?source=govdelive

ry&utm_medium=email&utm_source=govdelivery

Or go to:

http://www.fda.gov/Training/CDRHLearn/default.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

or contact:

[email protected]

or call 1-800-638-2041.

� FDA CAPA Webinar by Joseph Tartal

� http://fda.yorkcast.com/webcast/Play/c78cfebf72774163a59f8f6f197435451d

� FDA CAPA Webinar Slide Deck from Joseph Tartal

http://www.fda.gov/downloads/Training/CDRHLearn/UCM421767.pdf



� Federal Register Volume 61, Number 195 (Monday, October 7, 1996); Rules and Regulations;

Pages 52602-52662; Federal Register Doc. No.: 96-25720; Part VII; Department of Health and

Human Services; Food and Drug Administration; 21 CFR Parts 808, 812, and 820; Medical

Devices; Current Good Manufacturing Practice (CGMP); Final Rule; Docket No. 90N-0172; RIN

0910-AA09; Medical Devices; Current Good Manufacturing Practice (CGMP) Final Rule; Quality

System Regulation; effective June 1, 1997.

http://www.gpo.gov/fdsys/pkg/FR-1996-10-07/html/96-25720.htm

� Reference: GAO-11-556T “MEDICAL DEVICES: FDA’s Premarket Review and Postmarket Safety

Efforts”

http://www.gao.gov/new.items/d11556t.pdf

� Nuclear Regulatory Commission (NRC) -Attributes of an Effective Corrective Action Program

(DRAFT)

Source Link: http://pbadupws.nrc.gov/docs/ML1122/ML112241408.pdf



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� GHTF SG3, Global Harmonization Task Force, Study Group 3,

“Quality Management System – Medical Devices – Guidance on

Corrective and Preventive Action and Related QMS Processes”

http://www.imdrf.org/docs/ghtf/final/sg3/technical-docs/ghtf-sg3-

n18-2010-qms-guidance-on-corrective-preventative-action-

101104.pdf

� Good Documentation Practice (GDocP)

http://en.wikipedia.org/wiki/Good_Documentation_Practice

Contact Information

10 February 2015


Diane KulisekDirector, Quality Assurance and Performance ImprovementBruin Biometrics310-268-9494dkulisek@bruinbiometrics.comwww.bruinbiometrics.com

Diane KulisekFounder and Chief ConsultantCAPAtrak805-320-7879dkulisek@capatrak.comwww.capatrak.comLinkedIn: www.linkedin.com/in/dkulisek

Presented by Diane Kulisek 60



10 February 2015




THANK YOU!