FDA Best Audit Practices – Get Ready For The Inspection That Is Coming

2024 Best practice for FDA Audit and Inspection webinar will begin by discussing and emphasizing the importance of truthfulness to the process – truthfulness in performing the job on a daily basis, truthfulness in completing the regulatory documentation that is so much a part of our regulatory lives, and finally in the context of this webinar, truthfulness when interacting with FDA inspectors.

A key component of this webinar is the discussion of the tricks and techniques that inspectors use to elicit information. How you react and respond when they occur could impact your results.

Other key communication skills will be presented in the context of the inspection and interpersonal exchanges between inspectors and company associates being questioned.

We will complete the webinar by discussing how to handle, in the moment, adverse findings as they are identified by the inspector so as to not compound the issues and severity of the findings.

Areas Covered

2024 Best practice for FDA Audit and Inspection Covers

Importance of truthfulness
Importance of knowledgeability and confidence
FDA Tricks to elicit information
Arguing and challenging
Behavior during the inspection
Importance and role of documentation
Effective communication skills
Being deceptive
Opinion versus fact
Phrases never to say
Handling adverse findings during the inspection

https://conferencepanel.com/conference/fda-best-audit-practices-get-ready-for-the-inspection-that-is-coming

1. Live Webinar
on
FDAInspection
Readiness –Preparing
foran Inspection
Name of the Presenter.
CharlesHPaul,President
C.H.PaulConsulting,Inc.

2. Topics
2
◼Themechanicsof thereadinessprocess,auditing–whogetsaudited,
frequencyofaudits,andtheinspectionprocess explained
◼Typesof inspectionsand theirimplications
◼Theheartofcompliance–doingtherightthings right
◼Selectingyoursubjectmatter experts
◼TrainingyourSME’s–whatdotheyneed toknowandhowdoyoutrain
◼Inspectionpreparedness–whattoexpectandhowto prepare
◼Thereadinessinspectionfromtheauditor’s perspective
◼Responding/interactingwiththeinspectionteam–inspectionbehavior–
howto act–whattosayandwhatnottosay

3. WhodoestheFDAInspect?
◼FederalFood,Drug,andCosmetics(FD&C)Act, domestic drug
establishments, and Class II and Class III device manufacturers inspected
every two years
◼Foreignmanufacturers
◼Inspections conducted based on risk
◼Higher-risk products more likely to be audited
◼Facilities having historically significant violations
◼Inspection focus
Quality and Product Safety
Facility
Process
Data
3

4. PurposeofInspections
4
•CompliancewithFDAregulations
•Productdevelopment
•QualitySystem (QS) andmanufacturingpractices
•Controlsarein-placeandtheyareeffective
•Recalls, enforcement actions, complaints, significant
adverseeventreports,surveillance
•Ensureconsumerprotection

5. TypesofInspections
5
◼Pre-ApprovalInspections(PAIPost-ApprovalInspections
◼SurveillanceInspections
◼For-CauseorTriggeredInspections
◼ComplianceFollow-UpInspections
◼ForeignInspections
◼FocusedInspections
◼Risk-BasedInspections
◼Follow-UporRecurrentInspections
◼AdverseEventInspections
◼ImportInspections
◼Bioequivalenceand BioavailabilityInspections

6. TypesofInspections
◼Pre-ApprovalInspections
◼PostApprovalAuditInspections
◼DrugManufacturingInspections
6

7. Pre-ApprovalInspections
7
◼FDA approves New Drug Applications, Abbreviated New
DrugApplications,BiologicLicensingApplications
◼Assure that controls for manufacture, processing,
packing,andtestingareadequate
◼Pre-approvalinspectionperformedtoensurethat
manufacturercanmanufacturethedrug.

8. PostApprovalAuditInspections
8
◼Designedtoauditfor changesintheproductionand
controlpracticesthatoccurafterapproval
◼Post Approval Audit Inspections confirm that
commitmentshavebeencompletedorareunderway

9. DrugManufacturingInspections
9
Todeterminewhetherinspectedfirms
are operating in compliance with
applicablecGMPrequirements

10. BestPractices–“DotherightThingsRight”
10
◼Preparation
•Haveadequatelytrainedstaffwithrelevantexpertiseand accountability.
•Obtainuppermanagementsupport
•Utilizeandvalueindependentregulatorycomplianceand quality assurance
teams
•Ensurethecommitmentsmadefromprevious inspectionshavebeen
implemented
•Understandyour potentialqualitydatasourcessoinformationcanbequickly
andeasilysourcedasrequired
•Implementandassess aneffectivequalitysystem
•EnsurethereisadesignatedcompanyInspectionTeam
•Ensureallproperdocumentationandrecordsareup-to-date
•Maintaineffective ManagementReviewand CAPAsystems.
•Identifytruerootcausesofissuesusingappropriateproblem-solvingtools.
•Understandwhenaproduct,orqualityissueissignificant.
•Havedefinedmetricsystemsto monitoryourqualitysysteminorderto identify
trends,gaps,andopportunities

11. InspectionProcessOverview
11
❑Alertsystemactivated
❑CompanyInspectionTeammembersassemble
❑FDAprovidesthecompanywithForm482
❑FDAwillexplain whytheyareatyoursite
❑FDAprovidedwith afacilitytour
❑FDAinspectionteam,willrequestthedocumentsthey
need
❑FDAwillconducttheExitInspectionMeeting.
❑FDAfindingsare reviewed

12. PostInspection
•Dateofinspection
•Inspectionteammembers
•Reasons forresponse
•Responsetoeachciteddeficiency
•Descriptionofpreventive andcorrective action
•Itemsstillindispute
12

13. PostInspection
13
◼If the inspection has an Official Action
Indicated classification, FDA send a
warningletter
◼Companywillneedtoreply
◼FDAconductsafollow-upinspection
◼FDAmayissueaclose-outletter

14. WhyareSME’sIndispensabletotheOrganization?
14
◼ExpertiseinSpecificAreas
◼DemonstratingCompliance
◼PreparingDocumentation
◼TrainingandCoachingStaff
◼AddressingNon-ComplianceIssues
◼FacilitatingCommunication
◼EnsuringOngoingCompliance

15. WhoareSMEs?
15
◼QualityAssurance(QA)andQualityControl(QC)Experts
◼RegulatoryAffairsSpecialists
◼ManufacturingandProcessEngineers
◼MicrobiologistsandChemists
◼ClinicalResearchProfessionals
◼PharmacovigilanceExperts
◼LabelingandPackagingSpecialists
◼ValidationExperts
◼Food SafetyandHACCPExperts
◼ClinicalLaboratoryDirectors
◼EnvironmentalHealthandSafety Specialists
◼DocumentationandRecordsManagementExperts

16. WhyisProperSMESelectionImportantto theFDA
Inspection?
44
◼AccuracyandCredibility
◼RegulatoryUnderstanding
◼EffectiveCommunication
◼SmoothInspectionProcess
◼ConfidenceandProfessionalism
◼Problem-SolvingAbilities
◼RepresentationofExpertise
◼MitigatingRisks
◼ResourceEfficiency
◼Long-TermImpact
◼Employee Morale
◼OrganizationalPreparedness

17. SelectingSMEs
17
◼IdentifyRelevantAreas
◼DefineSMECriteria
◼Cross-FunctionalRepresentation
◼RegulatoryKnowledge
◼CommunicationSkills
◼ExperiencewithInspections
◼Problem-SolvingAbilities
◼PreparationandTraining
◼CalmUnderPressure
◼CollaborativeAttitude
◼Post-InspectionFeedback

18. PreparingSME’s
18
◼ProvideIn-DepthRegulatoryTraining
◼ReviewInspectionProcessandExpectations
◼MockInspectionWorkshops
◼CommunicationSkillsTraining
◼PrepareDocumentation
◼Familiarize withFacilityLayout
◼PrepareforQuestions
◼ConfidenceBuilding
◼TeamCollaboration
◼Role-PlayingScenarios
◼Post-PreparationFeedback

19. DoingtheRightThing
◼Alwaysbeprofessional
◼Bedressedproperly–neatandclean
◼Followallcompanycleanliness,movement,and
dressing requirements
◼Becourteousand politeatalltimes
◼Correct all errors and miscommunications when
discovered assoonaspossible
19

20. WhataSuccessfulFDAAuditLooksLike
20
◼CompliancewithRegulations
◼PublicHealthandSafety
◼MarketConfidence
◼ContinuedMarketAccess
◼OperationalImprovements
◼ReducedLegalandFinancialRisk
◼EnhancedConsumer Trust
◼FacilitatesInnovations
◼Employee MoraleandEngagement
◼EducationalOpportunity

21. TipsforDoingitRight
21
◼UnderstandtheScopeandStandards
◼MaintainComplianceatAllTimes
◼ConductRegularInternalAudits
◼PrepareYourTeam
◼OrganizeDocumentation
◼ReviewPastInspections
◼MockInspections
◼ImproveCommunicationSkills
◼EnsureFacilityReadiness
◼StayInformedAboutIndustryChanges
◼LegalandExpertConsultation
◼HandleIssuesProfessionally

22. Review
22
◼Alwaysbepreparedbydoing the rightthingsright
◼AlwaysmaintainacompliantGMPenvironment
◼Have effective andaccessiblecompliancedocumentation
◼Haveaplanforhowyou willmanageyourinspection
◼Beprofessionalduringan inspection
◼Demonstrateproperbodylanguage
◼Betimely inprovidingthedocumentsandsamplesrequested
◼Controltheflowofcommunication
◼Properlyanswerquestions
◼Respondto findingsthoroughlyandinatimelymanner

23. Questions
69
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