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October 11, 2007October 11, 200712:00 Noon 12:00 Noon -- 1:00 PM ET1:00 PM ET
Welcome to the Welcome to the PACT Educational Web PACT Educational Web
SeminarSeminar
Production Assistance for Production Assistance for Cellular TherapiesCellular Therapies
About PACTAbout PACTAn NHLBI-funded initiative committed to the advancement of effective cell therapiesPACT supports the development of novel somatic celltherapy products by providing production assistance to the cell therapy community, as well as educational training via web seminars and at meetingsPACT manufactures quality cell therapy products on behalf of investigators with funded clinical trials requiring support in product development and approval. PACT’s educational training focuses on three general areas: translational development/scale-up and manufacture of cell therapy products; and quality assurance and regulatory issues.
The PACT Group provides education, leadership and The PACT Group provides education, leadership and production assistance to the cell therapy community production assistance to the cell therapy community through federallythrough federally--funded contract manufacturing of funded contract manufacturing of
therapeutic cell products.therapeutic cell products.
PACT MembersPACT MembersBaylor College of
Medicine Center for Cell and Gene Therapy
University of Pittsburgh
Cancer Center
University of Minnesota
Molecular and Cellular
Therapeutics
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Web Seminar ObjectivesWeb Seminar ObjectivesLearn the steps to follow when preparing for a facility inspection Learn what and what not to do during inspections Learn and understand what inspectors focus during inspections
Presentation SlidesPresentation SlidesThe presentation slides for this web
seminar are available publicly on the main page at:
www.pactgroup.netwww.pactgroup.net
For prior web seminars choose “Educational Material Web Seminars”
TodayToday’’s Education Web s Education Web SeminarSeminar
Adrian Gee, Adrian Gee, MIBiolMIBiol, PhD, PhDBaylor College of Medicine
Center for Cell and Gene Therapy
Nancy Collins, PhDNancy Collins, PhDUniversity of Toledo Medical Center
Q & A SessionQ & A Session
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Web Seminar DescriptionWeb Seminar DescriptionPresenters will outline their approaches to the area
of Good Manufacturing Practice specifically for facilities involved with products for cellular therapies.
This web seminar will focus on preparing for an FDA inspection
Faculty Disclosure Faculty Disclosure InformationInformation
The Accreditation Council for Continuing Medical Education (ACCME) is the governing body that accredits AABB to provide continuing medical education credits for physicians. In accordance with the
ACCME Standards for Commercial Support, all faculty for this event have signed a conflict of interest form in which they have disclosed
any significant financial interests or other relationships with the industry relative to the topics they will discuss during this program. Such disclosure allows you to better evaluate the objectivity of the
information presented in the lectures. Please report any undisclosedconflict of interest you may perceive on the evaluation form.
Thank You.
Faculty Disclosure Faculty Disclosure InformationInformation
Faculty DisclosureNature of
Relationship Manufacturer/ProviderAdrian Gee None PACT member Baylor College of Medicine
Nancy Collins None non-PACT member University of Toledo Medical CenterAcacia Baker None PACT member The EMMES Corporation
Lisa Davis None PACT member The EMMES CorporationDavid Styers None PACT member The EMMES Corporation
Cassaundra Tickell None PACT member The EMMES CorporationDebbie Wood None PACT member The EMMES Corporation
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PACT UpdatesPACT UpdatesAABB Annual Meeting and TXPO 2007AABB Annual Meeting and TXPO 2007
October 20-23, 2007 Anaheim, California
PACT will be conducting a PACT session on Tuesday, October 23 from 2:00pm-5:00pm
“Cell Therapy Challenges: Product Characterization, Regulatory Compliance and Lessons Learned”
Visit www.aabb.orgwww.aabb.orgfor further details
National Heart, Lung, and Blood Institute, National Institutes of Health, Department of Health and Human Services
Administrative Center-The EMMES Corporation Contract Number: N01-HB-7166
Baylor College of Medicine Contract Number: N01-HB-37163
The University of Minnesota Contract Number: N01-HB-37164
The University of Pittsburgh Contract Number: N01-HB-37165
PACT is supported with PACT is supported with Federal funds from:Federal funds from:
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How to Survive Audits & Inspections
Adrian Gee
Center for Cell & Gene Therapy
Baylor College of Medicine
Houston, Texas
Types of InspectionsFDA Inspections
What happensAreas of emphasis & advice for complianceRegulatory BodyInspection adviceDo’s and Don’ts
Types of Inspection
Internal – part of Quality Plan
Institutional – part of Quality Program
ExternalContractorRegulatory Body
StateFederal – FDA
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External Inspections
Accreditation Agencies
Voluntary programs
Based on Standards
Do not have the power of law
Visits may or may not be scheduled in
advance
Occur on fixed schedule e.g. every 2 years
External Inspections
Regulatory AgenciesHave the power of law
May be scheduled or random
Compliance is not optional
Methods for compliance can vary
Inspectors vary in experience
Be prepared to explain products, processes and protocols
External Inspections
Upon arrivalWill issue form FDA 482
“Notice of Inspection”
Pre-designate a
Facility contact
Available throughout
inspection
Quality experience
Inform Institution?
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External Inspections
Provide meeting space
FDA will set agendaPurpose of visit
Usually will request tour
Then start to request
documentation/records
Initially will work in private
External Inspections
Will then meet with
facility contactQ and A, Clarification
Additional informationProcessing records
Variances
Training records
Equipment records
Environmental records
Additional documents
External Inspections
Exit interviewOutstanding issues
Formal notification of problems – Form 483
Time frame for compliance?
Closure of Facility if extensive non-compliance
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Areas of EmphasisDocumentation
Standard Operating Procedures
Manufacturing records
Equipment records
Training records
Quality plans – meetings, audits etc.
Variances – provide a history of problems
Advice on Standard Operating Procedures
Allow for biological variability
Every deviation must generate a Variance
Match closely to worksheets/batch records
Avoid too many cross-references
Couple to Training Program
Standard Operating Procedures
Make sure you have SOPs for Core GTP
Requirements (21CFR 1271.150)
FacilitiesEnvironmental controlEquipmentSupplies and ReagentsRecoveryProcessing & ProcessControls
Labeling ControlsStorageReceipt, Pre-distribution,shipment & distribution ofHCT/Ps
Donor eligibility, screeningand testing
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Areas of EmphasisDocumentation
Standard Operating Procedures
Manufacturing records
Equipment records
Training records
Quality plans – meetings, audits etc.
Variances – provide a history of problems
DocumentationManufacturing Records
Detail all steps in manufacturing per SOP
Identify person performing steps
Verification of critical steps & calculations
Appropriate correction procedure
Inclusion of all supporting documentation
Timely review
DocumentationTraining Records
Training SOPsDocumentation of ALL training
Initial, annual and any retraining
Competency assessmentsEducational activities
Continuing educationOSHABlood Borne PathogensSafety
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Areas of Emphasis Variances/Deviations
Available for all deviations from SOPs
Generated and reviewed promptly
Include potential impact on product & patient
Include corrective actionsFor current variance
To prevent future occurrences
Follow-up on corrective actions
Areas of EmphasisContamination
Donor screeningHealth historyInfectious disease testing
Aseptic Technique & Facility Cleaning
Changeover procedures between productsRemoval of product, paperwork & reagents
Cleaning of equipment - documented
Handling of multiple productsSegregation by room, incubator, shelf, time
Areas of EmphasisEnvironmental monitoring
Types of contaminants
Ability to detect contaminants
Rationale for pressure relationships
Rationale for type and frequency of
monitoring
Alert and Alarm levels and actions
Records and response to Alerts & Alarms
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Areas of EmphasisProduct Tracking
Donor to recipient & vice versa
Notification of non-conformity
Positive culture on product after infusion
Non-conforming donors
Recalls of products/reagents
Complaints file – actions & follow-up
Areas of EmphasisLabeling
New GTP regulations
Required language present
Required warnings present
Complies with IND application
Product name
Specific requirements under IND
Tips during Inspections
Listen to the inspector!Respond carefully to what was asked
Do not argue or become frustrated
Explain rationale for methods used
Admit deficiencies – do not try to hide
Seek advice from inspector
Correct on-site if possible
Learn from the experience!
Keep copies of requested information
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Advice for Inspections
Prepare
SOP?, pre-designate contact person, determine who
will be informed of inspection
Participate in accreditation programs, mock inspections,
audit programs
Review documentation – primary focus, audit
Make documents easy to review - organized
Good Luck!
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FDA INSPECTION:FDA INSPECTION:PREPARATION, INSPECTION & PREPARATION, INSPECTION &
FOLLOW UPFOLLOW UPNancy H. Collins, PhD.Nancy H. Collins, PhD.
Memorial SloanMemorial Sloan--Kettering Kettering University of ToledoUniversity of ToledoCancer Center Cancer Center Medical CenterMedical Center
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MSKCC CYTOTHERAPY LABORATORYMSKCC CYTOTHERAPY LABORATORY
Facility: Unclassified space, 500 ftFacility: Unclassified space, 500 ft22 lab, lab, 4 BSC, clerical & laboratory space4 BSC, clerical & laboratory space600 ft600 ft22 freezer space (>6000 products,freezer space (>6000 products,13 LN13 LN22, 3 mechanical), 3 mechanical)IsolexIsolex, , ClinMACSClinMACS
10/11/0710/11/07 33
MSKCC MSKCC CYTOTHERAPY LABORATORYCYTOTHERAPY LABORATORY
30 years servicing 43230 years servicing 432--bed hospital ,bed hospital , AlloAllolab merge with Auto lab 2001lab merge with Auto lab 2001FDA & New York State registeredFDA & New York State registeredFACT, AABB, & JCAHO accredited FACT, AABB, & JCAHO accredited CAP & inCAP & in--house proficiency studieshouse proficiency studiesNMDP collection and transplant centerNMDP collection and transplant centerPersonnel: 1 supervisor, 4 technologists, 1 Personnel: 1 supervisor, 4 technologists, 1 data manager, Laboratory Director, data manager, Laboratory Director, Medical DirectorMedical Director
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MSKCC CYTOTHERAPY LABORATORYMSKCC CYTOTHERAPY LABORATORY
Transplants: 200 Auto & 120Transplants: 200 Auto & 120 Allo TxAllo TxCollections: >700 PBPC collections, 30 BM Collections: >700 PBPC collections, 30 BM harvestsharvestsAuto, Auto, AlloAllo, GU transplants: , GU transplants:
Minimally manipulated (MM) & more than MM Minimally manipulated (MM) & more than MM Protocol (including CTN & multiProtocol (including CTN & multi--center), & offcenter), & off--protocol (standard of care) patients)protocol (standard of care) patients)Closed & open systemsClosed & open systemsIDE & IND trials prior May 2005 & in development IDE & IND trials prior May 2005 & in development (none on(none on--going at time of inspection)going at time of inspection)Cellular therapy (DLI, vaccines, NK & support for Cellular therapy (DLI, vaccines, NK & support for research studiesresearch studies
10/11/0710/11/07 55
MSKCC CYTOTHERAPY LABORATORYMSKCC CYTOTHERAPY LABORATORYQA STRUCTUREQA STRUCTURE
Hospital QA systemHospital QA systemDepartmental QA programDepartmental QA programMultiMulti--departmental Transplant Service QA departmental Transplant Service QA CommitteeCommitteeTransfusion Committee, quarterly reportTransfusion Committee, quarterly report
Operate within Blood Bank Quality PlanOperate within Blood Bank Quality PlanMajority QA activity done by lab personnelMajority QA activity done by lab personnelNo independent Quality Specialist who covers all No independent Quality Specialist who covers all aspects of programaspects of programBB Quality specialist signs off occurrence reportsBB Quality specialist signs off occurrence reports
Some institutional support (QA for research labs)Some institutional support (QA for research labs)Yearly auditYearly auditDevelopment of institutional SOPsDevelopment of institutional SOPs
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INITIAL PREPARATION INITIAL PREPARATION
Obtain information from ISCT, FACT, ASBMT, Obtain information from ISCT, FACT, ASBMT, AABB, & other laboratoriesAABB, & other laboratoriesFollow development of federal regulations Follow development of federal regulations
Establish which regulations applyEstablish which regulations applyTissue type, source & extent manipulationTissue type, source & extent manipulation
Registered & reregistered with FDA Registered & reregistered with FDA Follow development of New York State Follow development of New York State regulationsregulations
Registered & inspectedRegistered & inspectedYearly activity reportYearly activity report
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PRACTICAL PREPARATION (1)PRACTICAL PREPARATION (1)
Goal: operational systems & QA to meet Goal: operational systems & QA to meet most rigorous regulation/standardmost rigorous regulation/standardSupport from Department of Clinical Support from Department of Clinical Laboratories & MSKCC in Laboratories & MSKCC in biosafetybiosafety, IT, , IT, personnel training, intrapersonnel training, intra--laboratory laboratory proficiencies, HIPAA issuesproficiencies, HIPAA issues
Established separate QA Committee for lab, Established separate QA Committee for lab, network with other cellular therapy programsnetwork with other cellular therapy programs
Participate in CAP stem cell surveyParticipate in CAP stem cell survey
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PRACTICAL PREPARATION (2)PRACTICAL PREPARATION (2)
FACT preparation (with mock inspection) FACT preparation (with mock inspection) established program wide QA, better established program wide QA, better documentation within transplant programdocumentation within transplant programAABB surveys (with mock inspection) resulted AABB surveys (with mock inspection) resulted in clarification of process and design issuesin clarification of process and design issuesJCAHO inspection highlighted review & QA JCAHO inspection highlighted review & QA problem areasproblem areasMeetings with administrative committee & staff Meetings with administrative committee & staff to outline to outline cGTP cGTP requirements (e.g., EM in requirements (e.g., EM in unclassified space)unclassified space)
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PRACTICAL PREPARATION (3)PRACTICAL PREPARATION (3)Establish which systems are the most Establish which systems are the most important to the regulatory approach, important to the regulatory approach, concentrate on thoseconcentrate on thoseCore Core GTPsGTPs: Processing, recovery, donor : Processing, recovery, donor issues (eligibility, screening, testing), receipt, issues (eligibility, screening, testing), receipt, distribution, cleaningdistribution, cleaning
Contamination, crossContamination, cross--contaminationcontaminationQuality systemsQuality systemsSOPsSOPsRecord keeping, review, worksheet designRecord keeping, review, worksheet design
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PRACTICAL PREPARATION (4)PRACTICAL PREPARATION (4)
Central list of critical procedures, Central list of critical procedures, supplies, reagents with validation or supplies, reagents with validation or qualificationqualificationStandard format of worksheets, with Standard format of worksheets, with review and conclusions clearly indicated review and conclusions clearly indicated and easy to present to inspectorand easy to present to inspector
10/11/0710/11/07 1111
USING REGULATIONS USING REGULATIONS AS A GUIDEAS A GUIDE
Read regulations and compliance Read regulations and compliance documentdocumentOutline regulationsOutline regulations
List evidence of local compliance List evidence of local compliance (laboratory organization and/or (laboratory organization and/or operations, relevant SOPs)operations, relevant SOPs)List example and its locationList example and its location
Alert personnel from outside Alert personnel from outside laboratory for help laboratory for help
10/11/0710/11/07 1212
CORE CORE GTPsGTPs: THE PLACE TO START: THE PLACE TO START
FacilitiesFacilitiesEnvironmental Environmental controlcontrolEquipmentEquipmentSupplies & Supplies & reagentsreagentsRecovery of Recovery of HCT/PsHCT/Ps
Processing & Processing & processing controlsprocessing controlsLabelingLabelingStorageStorageReceipt, preReceipt, pre--distribution distribution shipment, shipment, distributiondistributionDonor eligibilityDonor eligibility
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EVIDENCE OF COMPLIANCEEVIDENCE OF COMPLIANCE
SOP 1.2 SOP 1.2 ““Quality ProgramQuality Program””SOP 1.1 SOP 1.1 ““Management of SOP Management of SOP
ManualManual””SOP 1.2 SOP 1.2 ““Quality SystemQuality System””SOP 1.8 SOP 1.8 ““Organizational Table andOrganizational Table and
Job DescriptionsJob Descriptions””Transfusion Committee QA reportsTransfusion Committee QA reportsMinutes Minutes Cyto Cyto Lab QA CommitteeLab QA Committee
…… establishestablish……quality program quality program ……
(a) General(a) General
1271.160 quality 1271.160 quality program.program.
Evidence of Compliance & NotesEvidence of Compliance & NotesRequirementRequirementRegulationRegulation
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FDA INSPECTION:FDA INSPECTION:
Unannounced, 2 day August 2005, coupled Unannounced, 2 day August 2005, coupled with BB and Donor Room inspection (3 day)with BB and Donor Room inspection (3 day)Inspection followed Inspection followed GTPGTP’’ss & compliance & compliance document, exactly and in orderdocument, exactly and in orderStandard review of documentation & chartsStandard review of documentation & chartsAssistance from coordinated clinical team Assistance from coordinated clinical team assembled for FACT accreditationassembled for FACT accreditationSpecial interest in Special interest in
donor eligibilitydonor eligibilityproduct release & reviewproduct release & reviewevent/complaint reportingevent/complaint reporting
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PROBLEMATICPROBLEMATICISSUESISSUES
Complexity of operations (Complexity of operations (alloallo vs. auto)vs. auto)Laboratory chart formatLaboratory chart formatLevels of review: immediate 2Levels of review: immediate 2ndnd tech tech check of worksheets, product release, final check of worksheets, product release, final chart review & signchart review & sign--offoffDivision of responsibility: e.g., Donor Division of responsibility: e.g., Donor eligibility documents in clinical charts eligibility documents in clinical charts Making copies of documents and chartsMaking copies of documents and charts
NOTE: Do not questionNOTE: Do not question……
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MSKCC INSPECTION MSKCC INSPECTION OUTCOMEOUTCOME
No 483No 483’’s s
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INSPECTION OUTCOME (1)INSPECTION OUTCOME (1)
Verbal recommendations onlyVerbal recommendations onlyRelationship with Blood Bank problematicRelationship with Blood Bank problematic
Occurrence reports not Occurrence reports not detailed enoughdetailed enoughSeparate lab operations Separate lab operations from Blood Bankfrom Blood BankSeparate tracking & trending Separate tracking & trending occurrences from Blood Bankoccurrences from Blood BankComplaint file format not reflect core Complaint file format not reflect core GTPsGTPsOccurrences followOccurrences follow--upup
10/11/0710/11/07 1818
INSPECTION OUTCOME (2)INSPECTION OUTCOME (2)
Verbal recommendations onlyVerbal recommendations onlyForms completion (crossForms completion (cross--outs, outs, areas of responsibility)areas of responsibility)Forms medical review (dates)Forms medical review (dates)Equipment files: organization, QC Equipment files: organization, QC schedule, archivingschedule, archivingEvaluation adverse reactionsEvaluation adverse reactionsClarification of responses to problems Clarification of responses to problems (ABO/Rh)(ABO/Rh)
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FDA INSPECTION FOLLOW UPFDA INSPECTION FOLLOW UP
Written report to Administrative Written report to Administrative Committee (who, what, where, Committee (who, what, where, when)when)Debriefing staffDebriefing staffNotes on all verbal recommendations Notes on all verbal recommendations with action itemswith action itemsThanks to institutional staffThanks to institutional staff
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THINGS I WISHED THINGS I WISHED I HAD DONEI HAD DONE
Rearranged equipment files Rearranged equipment files IQ, OQ, PQIQ, OQ, PQEliminated chronological filingEliminated chronological filing
Aligned systems more closely with Aligned systems more closely with GTPs GTPs & used more similar language& used more similar languageReviewed after review of recordsReviewed after review of recordsInstituted stronger relationship with Instituted stronger relationship with institutional QA systeminstitutional QA systemMock FDA inspectionMock FDA inspection
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COMPLIANCE DOCUMENT COMPLIANCE DOCUMENT INSTRUCTIONSINSTRUCTIONS
1.1. Review procedures for preparing the Review procedures for preparing the summary of records. summary of records.
2.2. Determine if HCT/Ps that have completed Determine if HCT/Ps that have completed the donor eligibility process are the donor eligibility process are accompanied by a summary of records. accompanied by a summary of records.
3.3. Are the records accurate, indelible, and Are the records accurate, indelible, and legible? legible?
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Combined Top Observations Combined Top Observations for all Inspections Done FY05 & FY06for all Inspections Done FY05 & FY06
…… written procedures for prevention of infectious written procedures for prevention of infectious disease, crossdisease, cross--contamination during processingcontamination during processing…… written procedures for all significant steps for written procedures for all significant steps for obtaining, reviewing, assessing the relevant obtaining, reviewing, assessing the relevant medical records of a donormedical records of a donor…… records which are accurate, indelible, legiblerecords which are accurate, indelible, legible…… fail to identify the person performing the work, fail to identify the person performing the work, the date the work was performed and the the date the work was performed and the particular tissue involvedparticular tissue involved…… fail to include documentation of destruction or fail to include documentation of destruction or other disposition of human tissueother disposition of human tissue
10/11/0710/11/07 2323
Combined Top Observations Combined Top Observations for all Inspections Done FY05 & FY06for all Inspections Done FY05 & FY06
…… written procedures for designating and written procedures for designating and identifying quarantined tissueidentifying quarantined tissue…… not accompanied by a summary or copies of not accompanied by a summary or copies of the donorthe donor’’s relevant medical recordss relevant medical records…… all steps performed in the testing, screening, all steps performed in the testing, screening, determining of donor eligibilitydetermining of donor eligibility…… were not were not established, maintained, and followedestablished, maintained, and followed…… documentation of receipt and/or distributiondocumentation of receipt and/or distribution………… test donor specimens for communicable viruses test donor specimens for communicable viruses using FDA licensed donor screening tests using FDA licensed donor screening tests SOP for the release of HCT/Ps from donors that SOP for the release of HCT/Ps from donors that test reactive for CMV test reactive for CMV Environmental conditions are not monitoredEnvironmental conditions are not monitored……
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Combined Top Observations Combined Top Observations for all Inspections Done FY05 & FY06for all Inspections Done FY05 & FY06
……Procedures not established for processing, Procedures not established for processing, labeling control, storage/distribution, handling labeling control, storage/distribution, handling positive test resultspositive test results……Procedures not followed for donor screeningProcedures not followed for donor screening……quality program not established, not ensure quality program not established, not ensure documentation of corrective actions, investigation documentation of corrective actions, investigation and trending of deviations and trending of deviations Supplies and reagents not verified, receipt not Supplies and reagents not verified, receipt not recordedrecordedRecords not identify person performing workRecords not identify person performing workDonor testing not done with FDA Donor testing not done with FDA approved/cleared tests, manufactureapproved/cleared tests, manufacture’’s s instructions not followedinstructions not followed
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ACKNOWLEDGEMENTSACKNOWLEDGEMENTS
Cytotherapy Cytotherapy laboratory staff & laboratory staff & Administrative CommitteeAdministrative CommitteeMSKCC administrationMSKCC administrationDepartment of Clinical Laboratory Department of Clinical Laboratory administration and support staffadministration and support staffFACT preparation teamFACT preparation teamClinical transplant teams (auto & Clinical transplant teams (auto & alloallo))
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RESOURCESRESOURCESFDA websiteFDA website
Guidance documents Guidance documents www.www.fdafda..govgov//cbercber//genetherapygenetherapy//gtpubsgtpubs..htmhtm
HTC/P compliance documents HTC/P compliance documents www.www.fdafda..govgov//cbercber//cpgcpg//cpgcpg..htmhtm
ISCT, ISCT, www.celltherapysociety.orgwww.celltherapysociety.org
LRA, MemberLRA, Member’’s Lounges Lounge
AABB, AABB, www.www.aabbaabb.org.org
PACT, PACT, www.www.pactgrouppactgroup.net.net
NMDP, NMDP, www.marrow.orgwww.marrow.org
A little help from your friendsA little help from your friends
1
Q & A Session
Production Assistance for Cellular TherapiesProduction Assistance for Cellular Therapies
October 11, 2007 October 11, 2007 12:00 Noon 12:00 Noon -- 1:00 PM ET1:00 PM ET
1
Speaker Contact ESpeaker Contact E--mailsmails
Adrian Gee, Adrian Gee, MIBiolMIBiol., PhD., [email protected]@txccc.org
Nancy H. Collins, PhDNancy H. Collins, [email protected]@verizon.net
Presentation SlidesPresentation Slides
The web seminar presentation is available publicly at
http.//www.pactgroup.net http.//www.pactgroup.net Select “Educational Material”
CME Accreditation CME Accreditation StatementStatement
AABB is an approved, accredited provider (Provider number 0000381) by the Accreditation Council for Continuing
Medical Education (ACCME) to provide continuing medical education for physicians. AABB designates this education activity for a maximum of 1 category 1 credit toward the AMA Physicians Recognition Award. Each physician should claim only those credits that he/she
actually spent in the activity.
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CME CreditCME Credit
Sign and fax roster to 240Sign and fax roster to 240--306306--25272527Complete an online surveyComplete an online survey
http://www.surveymonkey.com/s.aspx?sm=wVTV_2fGdI0ayzgF28Ia_2fWGQ_3d_3d(link above embedded in the reminder email sent Wednesday, October 10th)
If you are interested in obtaining CME creditfor attending this web seminar, please note
that each attendee must:
Note: Please complete within 48 hrs of the programNote: Please complete within 48 hrs of the program.
AABB Live Learning CenterAABB Live Learning Center
After the rosters have been processed, you will receive an email from AABB with instructions on how to print your
CME/CE certificates.
Thank you for attending!Thank you for attending!To register for updates on upcoming web seminars, workshops, and PACT attended
meetings visit us on the web at:www.pactgroup.netwww.pactgroup.net
