PowerPoint Presentation

Quality Control and Quality Assurance Is There Really a Difference??1

Twenty years of industry experienceClinical RN to Chief Operating Officer

Patrick R. Ayd MBA, BSN, RNPresident/CEO/Lead Auditor of ClinPharm Network, Inc. 2GCP audits & manage Site QA programs

Click to add textIndustry experience spanning 20 years Have held positions from clinical RN to COOPresident/CEO/Lead Auditor of ClinPharm Network, Inc. Conduct site audits and manage independent Quality Assurance programs

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Workshop GoalIdentify the foundational Building Blocks essential to the development of a Quality Clinical Trial Site

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Take Away-Solid Quality Control SOP

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4Gain an increased perspective on FDA expectations during and after an audit

Clarify the differences between Quality Control (QC) and Quality Assurance (QA)

Comprehend the importance of Standard Operating Procedures(SOP) in QC and QA

Conduct quality control review on actual source documents

Workshop Objectives12

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Receive a valid quality control (QC) SOP template

NO need to click for text to appearTake Away-Solid Quality Control SOP template

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Why is a Quality Organization Critical?

Business Development

PI is Solely Responsible

Data Acceptability

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Click to add textFor the obvious reasonsAny Site Owners or PIs in the room??The PI has to have the confidence that all delegated tasks are being performed as s/he wants them performed

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Quality Control Definition

Verifying and maintaining a desired level of quality in an existing product or service by careful planning, use of proper tools, continued inspection, and corrective action as required6

Quality Assurance DefinitionA system for ensuring a desired level of quality in the development, production, or delivery of products and services with continued inspection, and corrective action as required

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Quality Control vs. Quality Assurance

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Verifying And Maintaining A Desired Level Of Quality In An Existing Product Or Service by Careful Planning, Use Of Proper Tools, Continued Inspection, and Corrective Action as Required

System For Ensuring A Desired Level Of Quality In The Development, Production, Or Delivery Of Products & Services With Continued Inspection,& Corrective Action as Required

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Key to Good Quality Control

Formal, Well Documented Process Documentation of QC Performed

Ink Stamp ProcedureInvolve StaffIn ProcessQuality Control9

Click to add textFormal, Well Documented Process (SOP)Documentation of QC PerformedInvolve Entire Staff in ProcessDescription of Ink Stamp Procedure-Lower right reverse side methodWell discuss further in a bit when we discuss the Quality Control SOP

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Varying Degrees of Quality Control10

Click to add textThis is where team work becomes criticalWhole checking: Is the document whole? Are there any holes that need to be completed i.e. signatures, initials, data, etc.Believable Data: Does the data make sense i.e. BP 80/120, HR 312, LMP data in a male chartConsistent Data: Is the data consistent, BP at last visit 102/60, now 140/88, HR changes, no middle initial used prior, now present, etc.

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Building Blocks of a QC SOP

Standard Operating Procedure11

In order to check if certain processes were done correctly you need to have a solid base of SOPs, which includes of course an SOP on the Quality Control process.11

Quality Control Standard Operating Procedure 12Define WHO will conduct the QC processDefine WHEN the QC process will be completedWhat documents will be QCd 100% of the timeThe % of other documents that will be QCdDo not alter/modify sponsor provided or sites source documentsPrecisely describe the documentation processUse the lower right reverse side methodUse unusual ink color for stampFlag documents that have problemsDo not stamp documents until complete problem resolution

Your SOP needs to define WHO will conduct the QC processWHEN the QC process will be done (can be different by document, i.e. ICF)WHAT documents will be QCd 100% i.e. ICFs WHAT % of standard documents will be QCdHOW the QC process will be documented12

Breakout Session

13Review of Source DocumentationDocumentation of Quality Control

30-45 Minutes

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Quality Assurance DefinitionA system for ensuring a desired level of quality in the development, production, or delivery of products and services with continued inspection, and corrective action as required

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Quality Assurance looks at larger processes versus individual completed documents. Is there a system or tools in place to ensure quality?15

QA Function needs to be Truly Independent of Clinical Function

Reporting RelationshipJob StabilityOutsource

Report Directly to CEO or Medical Director-based on organizations size and structureThe Quality Assurance person cant be constantly worried about job stability because of reporting problems or performance issuesFor most organizations the answer is to outsource the Quality Assurance function, its cheaper and much more effective16

Foundation of a Quality Organization

SOPs and Training Program

Performance Evaluation System ++

Job Descriptions

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Though only 3 blocks, there are 6 basic tenants of a quality organization separate piecesadd Quality Control and Quality Assurance programsThese are must haves in order to run an efficient Quality Assurance program internally or externallyJob Description: Lets the employee know what procedures/tasks they are responsible forSOPs: Shows employees how the procedures/tasks are performed at our trial siteTraining: Train the employees on a regular basis how to perform the procedures/tasks they are responsible forPerformance Evaluation: Lets the employee know how they are performing to the standards that have been set (yes this is a pain)WITHOUT ALL 4 IT IS DIFFICULT TO CREATE AND IMPLEMENT A CAPA WHEN ISSUES IDENTIFIED BE IT INTERNALLY OR EXTERNALLY IDENTIFIED.

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Types of Quality Assurance AuditsTrial Specific AuditFacility GCP AuditIn Process AuditVendor Audit~

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Dont explain specifics, slides to follow18

Trial Specific AuditHigh EnrollerOut of your typical therapeutic areaPoor monitoringPoor results from internal review~

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Overall Facility GCP AuditClinical Equipment MonitoringSample HandlingInformed Consent ProcessTraining and Training DocumentationProvision of Emergency CareInvestigational Product (IP)/Drug AccountabilityPI InvolvementScreeningRecruitmentData Collection20

Just to list a few, there are many more20

In Process AuditObserve:Screening VisitConduct of Informed Consent ProcessInvestigational Product (IP)/Drug DispensingAdverse Event (AE) Assessment21

Click to start textThis is just a list of examples. Can you think of any others??21

Vendor AuditPharmacy ProviderLong term Storage FacilityLocal LaboratoryLocal IRB~22

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Quality Assurance CycleCritical Link23Critical LinkCAPA

Click to add Critical Link text after change and training23

Documentation of a Quality Assurance ProgramBinder that keeps all information in one placeProtected QA DocumentsAudit ReportsCAPA PlansAudit CertificatesReviewer of all SOPs24

Perspective on an FDA Audit

During an Audit

Organized regulatory bindersOrganized patient chartsOrganizational chartTraining records

After an Audit

No more Further Avoidance of SameDont throw anyone under the busVague terms of changes made or improvements Quality Assurance/ Improvement program in place

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I have been through 11 FDA audits and have helped clean up after another 5.Spend the money necessary to purchase good binders and section dividersDont rush to recycle binders and section dividersIf a 483 is issued and you respond,Nothing worse than your response was unacceptable, no further response required.25

26Questions? Comments?

ReferencesDictionary.com

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