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FDA’s Pharmaceutical FDA’s Pharmaceutical Inspectorate Inspectorate
Robert ColemanRobert Coleman
National Expert Drug InvestigatorNational Expert Drug Investigator
Food and Drug AdministrationFood and Drug Administration
CertificationCertification
BackgroundBackground
Certification begun in 1994Certification begun in 1994
To create consistent inspectional activities To create consistent inspectional activities nationally through a uniformly managed nationally through a uniformly managed training & audit process for our training & audit process for our investigators.investigators.
Will proceed as long as adequate funding Will proceed as long as adequate funding and support exists. and support exists.
PurposePurpose
Provide training to develop & maintain a Provide training to develop & maintain a qualified & effective staff of investigators. qualified & effective staff of investigators.
Provide a structured mechanism for Provide a structured mechanism for investigators to obtain, maintain & investigators to obtain, maintain & consistently apply the required consistently apply the required competencies competencies
Objective: Assure our Investigators Objective: Assure our Investigators continue to have the skills & knowledge continue to have the skills & knowledge necessary to do their jobs. necessary to do their jobs.
PlayersPlayers
Human Resource CommitteeHuman Resource CommitteeDivision of Human Resource DevelopmentDivision of Human Resource DevelopmentCourse Advisory Committee(s)Course Advisory Committee(s)Certification Board(s)Certification Board(s)Performance AuditorsPerformance AuditorsCertification CandidatesCertification CandidatesDistrict ManagementDistrict ManagementOffice of the Director of Regional OperationsOffice of the Director of Regional OperationsDivision of Field InvestigationsDivision of Field Investigations
Program Areas with Program Areas with CertificationCertification
Medical DevicesMedical Devices
BloodBlood
SeafoodSeafood
DrugsDrugs
Drug CertificationDrug Certification
Level ILevel I
Level IILevel II
Level IIILevel III
Level ILevel I
MandatoryMandatory
For all new hire investigatorsFor all new hire investigators
Training completed in the first 12-Training completed in the first 12-months.months.
Demonstration of competency via a Demonstration of competency via a successful performance audit results in successful performance audit results in Level I Certification.Level I Certification.
Level I TrainingLevel I Training
Web based training courses and OJT Web based training courses and OJT experience experience
Classroom training courses Classroom training courses – Basic Food and Drug LawBasic Food and Drug Law– Evidence DevelopmentEvidence Development– Investigative InterviewingInvestigative Interviewing– Quality AuditingQuality Auditing
Level I Audit CriteriaLevel I Audit Criteria
First line supervisor looks for:First line supervisor looks for:– General Investigational Practices General Investigational Practices – EvidenceEvidence
Recognize, Collect and Identify Appropriate Recognize, Collect and Identify Appropriate Evidence to Support FindingsEvidence to Support Findings
– Verbal CommunicationVerbal Communication– Written CommunicationWritten Communication– Professionalism Professionalism
Level II Drug CertificationLevel II Drug Certification
Not mandatoryNot mandatory
Candidate mustCandidate must– Spend at least 25% of time in drug programSpend at least 25% of time in drug program– Submit packet to Level II Drug Certification Submit packet to Level II Drug Certification
BoardBoard– Pass performance auditPass performance audit
– The Performance Auditor is a Board Approved FDA The Performance Auditor is a Board Approved FDA employee who completed their Level II Certification employee who completed their Level II Certification
– Be recertified every 3 years (18 CEU hours)Be recertified every 3 years (18 CEU hours)
Level II Drug Investigator Level II Drug Investigator Certification PrerequisitesCertification Prerequisites
Must meet Level I criteriaMust meet Level I criteriaRequired training coursesRequired training courses– Drug Manufacturing & Quality Control Training Drug Manufacturing & Quality Control Training
Course Course – Pre-Approval Inspections Training CoursePre-Approval Inspections Training Course– Industrial Sterilization of Drugs & Devices Industrial Sterilization of Drugs & Devices
Training Course Training Course – Computer Systems Validation Training Course Computer Systems Validation Training Course – Active Pharmaceutical Ingredient Manufacturing Active Pharmaceutical Ingredient Manufacturing
Training Training
Level II Certification BoardLevel II Certification Board
National ExpertNational Expert
Experienced Field InvestigatorExperienced Field Investigator
Expert from CDERExpert from CDER
Expert from CVMExpert from CVM
Field ManagerField Manager
DHRD SpecialistDHRD Specialist
Level II Audit CriteriaLevel II Audit Criteria
Compliance assessmentCompliance assessmentEvidenceEvidence
Verbal CommunicationVerbal Communication
Written CommunicationWritten Communication
ProfessionalismProfessionalism
Level III Drug CertificationLevel III Drug Certification
AKA “Pharmaceutical Inspectorate”AKA “Pharmaceutical Inspectorate”
Not mandatoryNot mandatory
Planning for 50 members by FY07Planning for 50 members by FY07
Who is eligible for the PI?Who is eligible for the PI?
FDA employees with at least 3 years of experience in FDA employees with at least 3 years of experience in inspecting drug firms.inspecting drug firms.– ORA Field InvestigatorsORA Field Investigators– CDER/CVM personnelCDER/CVM personnel– Investigative analystsInvestigative analysts
Certified at Level IICertified at Level II– Must pass a six system auditMust pass a six system audit
Endorsed by District/Office managementEndorsed by District/Office management
Selected/nominated by Level III Certification BoardSelected/nominated by Level III Certification Board
How do they join?How do they join?
Submit their name to their supervisor for Submit their name to their supervisor for consideration.consideration.
Initial nomination will have concurrence from Initial nomination will have concurrence from their District management.their District management.
Submit a certification packet to the Level III Submit a certification packet to the Level III Drug Investigator Certification Board for Drug Investigator Certification Board for review and selection.review and selection.
The Certification Board will screen the The Certification Board will screen the applicant.applicant.
Level III Drug Certification Level III Drug Certification BoardBoard
2 Field Investigators (National Experts) 2 Field Investigators (National Experts) operating at Level IIIoperating at Level III2 Experts from the CDER2 Experts from the CDER2 Experts from the CVM2 Experts from the CVM1 DFI Program Expert1 DFI Program Expert1 ORA Field Manager from the appropriate 1 ORA Field Manager from the appropriate Field CommitteeField Committee1 Representative from DHRD1 Representative from DHRD
Who are the candidates?Who are the candidates?
FDA personnel (mainly Investigators) with FDA personnel (mainly Investigators) with specialized experience & specific training in specialized experience & specific training in evaluating pharmaceutical manufacturing.evaluating pharmaceutical manufacturing.
Report directly to ORA District Office Report directly to ORA District Office management for assignments.management for assignments.
Spend about 80% of their time conducting Spend about 80% of their time conducting drug inspections (domestic & foreign) and drug inspections (domestic & foreign) and related activitiesrelated activities..
Expected Competencies for PIExpected Competencies for PI
Regulating Pharmaceutical Quality and the Regulating Pharmaceutical Quality and the Relationship to FDA’s MissionRelationship to FDA’s Mission
Risk Management Risk Management
Advanced Quality Systems Advanced Quality Systems
Pharmaceutical SciencePharmaceutical Science
Current Regulatory Programs and Current Regulatory Programs and Procedures Procedures
TechnologyTechnology
InvestigationalInvestigational
Selection Criteria for the PISelection Criteria for the PI
Candidate demonstrates:Candidate demonstrates:– Willingness to share his/her knowledge Willingness to share his/her knowledge
with colleagueswith colleagues– Initiative to go beyond the “expected” or Initiative to go beyond the “expected” or
“required”“required”– Innate ability to separate important issues Innate ability to separate important issues
from unimportant issuesfrom unimportant issues– Currency of knowledgeCurrency of knowledge– Desire to excelDesire to excel
Selection Criteria for the PISelection Criteria for the PI
Candidates will:Candidates will:– Primarily focus on conducting pharmaceutical Primarily focus on conducting pharmaceutical
inspectionsinspections– Successfully meet all Level I and Level II Successfully meet all Level I and Level II
requirementsrequirements– Recognize when additional training is neededRecognize when additional training is needed– Be a recognized resource on advanced Be a recognized resource on advanced
technology or inspectional techniquestechnology or inspectional techniques– Demonstrate effective verbal and written Demonstrate effective verbal and written
communication skillscommunication skills
Admission to the PIAdmission to the PI
To become a PI member the candidate To become a PI member the candidate must:must:– Have their packet successfully reviewedHave their packet successfully reviewed– Pass the screeningPass the screening– Pass the trainingPass the training– Participate in Center detailsParticipate in Center details– Pass final evaluationPass final evaluation
What training will be provided?What training will be provided?
First course completed in 2005First course completed in 2005
Second course scheduled in 2006Second course scheduled in 2006– Still under developmentStill under development
Some Course Agenda ItemsSome Course Agenda Items
Quality Systems & Quality Systems & ToolsTools
Risk Assessment & Risk Assessment & ManagementManagement
Critical ThinkingCritical Thinking
Quality by DesignQuality by Design
Design of Design of ExperimentsExperiments
ICH GuidancesICH Guidances
Process CapabilityProcess Capability
Technology TransferTechnology Transfer
CAPACAPA
PATPAT
PI Course Advisory GroupPI Course Advisory Group
ORA, CDER training manager & trainersORA, CDER training manager & trainers
ORA/DFI representativesORA/DFI representatives
ORA Field investigatorORA Field investigator
ORA Field ManagerORA Field Manager
CDER, CVM representativesCDER, CVM representatives
Others (on a course by course basis)Others (on a course by course basis)
PI ExpectationsPI Expectations
Seek additional activities to further their expertise.Seek additional activities to further their expertise.Develop & implement formal training programs for Develop & implement formal training programs for FDA, industry, and state/local officials.FDA, industry, and state/local officials.Develop/evaluate programs, policies, or procedures Develop/evaluate programs, policies, or procedures in their area of expertise.in their area of expertise.Auditors for the Level II or III Drug Certification Auditors for the Level II or III Drug Certification programs.programs.Participate in professional activities that maintain, Participate in professional activities that maintain, broaden, or enhance their knowledge.broaden, or enhance their knowledge.
HOW TO REACH MEHOW TO REACH ME
Robert C. ColemanRobert C. Coleman
US FDAUS FDA
60 Eighth Street, N.E.60 Eighth Street, N.E.
Atlanta, Georgia 30309Atlanta, Georgia 30309
USAUSA
Tel: 404-253-1295Tel: 404-253-1295 FAX: 404-253-1205FAX: 404-253-1205
Email: Email: [email protected]@fda.hhs.gov
