I nt r oduc t i on

Thissix-weekcourseentitledCurrent GoodManufacturingPractice(cGMP)
Regulatory Principles was developed by Purdue Universitys Department
of Industrial andPhysical Pharmacy, oneof theleadingindustrial pharmacy
programsintheworld.
This programwill enhance your abilities to locate and interpret laws and
regulationsrelevant tothepharmaceutical industry, andthendesign, imple-
ment, and monitor best practices in your organization to assure compli-
ance. Also, theprogramprovides abroadandthoroughunderstandingof
theentireprocessof drugdevelopment: fromearlydiscoveryandtoxicology
research, throughclinical trialsandmanufacturing, andfinallyregistration.
Thecourseprovideseducationintheimportant areasof regulatoryandquality
compliance. Inadditiontoaclassroomeducation, thecourseisdesignedto
providehands-onpractical experienceworkinginthelaboratoryandat the
ChaoCenter for Industrial PharmacyandContract Manufacturingat Purdue.
Studentswill improvetheir knowledgeof regulatoryandcomplianceissues
whiledevelopingfamiliaritywiththemanufactureof solidoral dosageforms
followingCurrentGoodManufacturingPractices(cGMP).
Studentswill attendclasses, participateinroundtablediscussionsandprob-
lemsolvingsessions, performlaboratoryexperiments, writebatchrecords,
prepareanactual batchof Seromycin(placebo), reviewthecompletedbatch,
andreleaseit asif it werefor themarketeduse.
ThecGMPTrainingProgramisbasedonahighlysuccessful graduatecer-
tificateprograminRegulatoryandQualityCompliancealreadyestablished
bytheDepartment of Industrial andPhysical Pharmacy. Thegraduatecer-
tificate programhas been developed as a joint effort of Purdue University
Regi st r at i on f or
Par t 1: Two-week c GMP Tr ai ni ng Pr ogr am
atPurdueUniversity, August9-20,2004
RegistrationforPart2, weeks 3- 6, tobeannouncedatalaterdate.
Name __________________________________________________
Title ____________________________________________________
Company________________________________________________
Address_________________________________________________
Address_________________________________________________
Phone __________________________________________________
Fax ____________________________________________________
E-mail __________________________________________________
I requireauxiliaryaidsandservicesbecauseof adisability. Please
contact meat theaboveaddress.
I request vegetarianmeals.
Tui t i on Fee
Register mefor Part 1of thecGMPTrainingProgramat acost of
$5,000per participant.
Lodgi ng
Singleroomsor groupratesfor housingareavailable. Pleasecontact
Prabir Basubye-mail at prabir1960@purdue.eduor NancyDavis,
ndavis@pharmacy.purdue.edu,beforeJuly1, 2004, for reservations.
Payment Met hod
Wiretransfer inU.S. dollarsmadepayabletoPurdueUniversity.
Other ________________________________________________
Returnthis formwithpayment to:
OCECBusinessServices Fax: 765-494-0567
PurdueUniversity
Stewart Center, Room110
128Memorial Mall
West Lafayette, IN47907-2034
USA
Ifpaymentis beingmadeformorethanoneparticipant, pleasecomplete
oneregistrationformforeachparticipantandmail orfaxtogether.
Conf i r mat i on Not i f i c at i on
Uponreceipt of thisregistrationformandyour payment, aconfirmation
e-mail will besent toyoufromPrabir Basu(prabir1960@purdue.edu)
Cont i nui ng Educ at i on Uni t s
Youwill receive45ContinuingEducationUnitsuponcompletionof the
Two-weekcGMPTrainingProgram.
Canc el l at i on Pol i c y
A50percent refundfor thetwo-weekcoursewill beissuedif arequest
ismadebyJune30, 2004. PurdueUniversityisnot responsiblefor
costsincurredduetocancellation.
PurdueUniversityis anequal access/equal opportunityuniversity.
Last year, at theWorldHealth
Organization headquarters in
Geneva, Switzerland, Eli Lilly
andCo. announced that it will
teamwithPurdueUniversityto
teach other nations how to
manufacture drugs to fight
tuberculosis.
The partnership involves the
WorldHealthOrganization, the
U.S. Department of Healthand
HumanServices, theCenters
for Disease Control and Pre-
vention, Harvard Medical
School, andPurdueUniversity.
ThepartnershipyieldsPurduesfirst drugmanufacturingcontract for the
School of Pharmacys GoodManufacturingPractices facility, whichwill
belocatedinthePurdueResearchPark. Whencompletedinlate2004,
National Center
for Advanced
Pharmaceutical Science,
Manufacturing, and
Education
Training Program
Cur r ent Good
Manuf ac t ur i ng
Pr ac t i c e (c GMP)
Regul at or y
Pr i nc i pl es
For moreinformation, pleasecontact:
Prabir Basubycalling(765) 494-9614or
by e-mail at prabir1960@purdue.edu
NancyDavisbycallling(765) 426-9089or by
e-mail at ndavis@pharmacy.purdue.edu
A six-weekprogrampresentedby
Purdue University in West Lafayette,
Indiana, attheChaoCenter for Industrial
PharmacyandContractManufacturing
Withemphasis on:
Food and Drug Law,
Drug Discovery and Drug Development,
Good Regulatory Practices,
Preparation of Chemistry, Manufactur-
ing and Control (CMC) Documents,
Process Analytical Technology, and
Practical Hands-on Learning
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CharlesO. Rutledge, PurdueUniversity
117-1589-8052BT
Training Program
Cur r ent Good Manuf ac t ur i ng Pr ac t i c e (c GMP)
Regul at or y Pr i nc i pl es
and the leading pharmaceutical companies, Abbott Laboratories, located in
Chicago, Illinois, andEli LillyandCo., locatedinIndianapolis, Indiana.
Tr ai ni ng Dat es
Thesix-weekcoursebeginswithatwo-weeksessionfromAugust 9-20, 2004,
at Purdue Universitys West Lafayette campus. The four-week course ses-
sionswill beheldnext year, 2005; final datetobeannounced.
Pr ogr am Obj ec t i ves
Throughout theworld, thereis aneedfor cGMPeducation. This courseis an
important first stepandprovides anoverviewof all-important areas of cGMP.
Highlightsinthiscoursearestrategiesfor themanufactureof drugsfor tubercu-
losisandother infectiousdiseases. Auniversitylevel courseisofferedbecause
cGMPregulationsarerapidlychangingduetochangesintheindustry, improved
methodsof analysis, andchangesintheFDAandother regulatorybodies.
Highqualityandappropriatecomplianceareessential for thesuccessof phar-
maceutical companies. Poor qualityandnon-complianceresult inclosedop-
erations or organizations, fines, ruinedcareers andpublic images, andloss
of credibility. The objective of this course is to introduce closed scientists
throughout the world to the essentials of quality assurance, quality control,
andqualitysystems.
Thecoursewasdevelopedtoaddressthelackof broadeducationinregula-
tory sciences in conventional university curricula. For example, operations
scientistsarewell trainedinmanufacturingandmethodsof analysisbut few
haveany formal educationonthepolicy andcoreprinciples of cGMP. This
course provides a basic overviewof regulatory issues enabling operations
scientists, chemists, manufacturingprofessionals, and other researchers to
performwell intheir assignedcapacities.
thefacility will allowPurduetoteachstudents andprofessionals world-
wideabout commercial drugproductionandmanagement.
Purduesmanufacturingfacilitywill bemorethanjust agreat placeto
receivetrainingindrugmanufacturing, saidCharlesO. Rutledge, ex-
ecutivedirector of DiscoveryPark. Bynatureof itsrelativelysmall size,
it will be able to produce drugs profitably in small quantities. Often,
thesedrugsareneededonlybyasmall segment of apopulation. With
suchsmall profit margins, this is somethingthat larger manufacturers
cannot dobecauseof their larger overhead.
Purduesfirst productswill beantibioticsthat curemultipledrug-resis-
tant tuberculosis (MDR-TB). Lilly is the original manufacturer of the
drugs, and the company is nowassisting developing countries with
manufacturingthedrugsthemselves, asthediseaseisfar morepreva-
lent outsidetheindustrializedworld.
Our effortswill fill ashortageinthedrugmarket, not onlybymanufac-
turing the drugs, but also by assisting other countries with their own
manufacturingefforts, Rutledgesaid.
Pur due, Li l l y f or m i nt er nat i onal dr ug
manuf ac t ur i ng par t ner shi p
Par t 1: Two-w eek c GMP
Tr ai ni ng Cour se
August 9toAugust 20, 2004, will focusonthefollowing:

Food and Dr ug Law
G. Thomas Wilson, professor, andguestlecturers
Objectives
List thecritical conceptsof adulterationandmisbrandingastheyapply
todrugs, devices, andcosmetics.
Definetheneedfor strict controlsontheproductionof drugs, devices,
andcosmetics.
Understandtheapplicationof thebasicconstructsof thelawsandregu-
lations as they seek toholdmanufacturers, packers, anddistributors
accountablefor thequalityof drugs, devices, andcosmetics.
List thepotential for harmsought tobepreventedbypassingthevari-
ouslawsandregulations.
Writeanobjectiveanalysis of anassignedissueutilizingavailablein-
formationfromcasesandstatutes.
Demonstratetheabilitytoreadandanalyzeacourt decisionandpresent
thecase totheclass. It isalsoexpectedthat thestudent will beable
to prepare an active outline tracing the progress of lawthrough the
presentedcases.
Dr ug Devel opment
SteveByrnandMichael Schmidt, professors, andguestlecturers
Objectives
Define roles in the drug development process and describe key job
functions.
Learnabout thepositivecontributions of thepharmaceutical industry
andthebenefitsof employment.
Gainanappreciationof other componentsandjobfunctionsinorder to
beamoreunderstandingandbetter cross-functional teamparticipant.
Learnabout newapproachesindrugdiscoveryresearchanddevelop-
ment today: technologies, practices, andstrategies.
Good Regul at or y (GXP) Pr ac t i c es (GLP, GCP,
c GMP)
Michael SchmidtandStephenByrn, professors, andguestlecturers
Objectives
Describe the regulations of the pharmaceutical industry, the reasons
for the regulations, and the perils and consequences of non-compli-
ance.
Identifythechallengesandpitfallsineachphaseof drugdevelopment
andexplorehowproblemscanbeavoidedlogicallyandincompliance.
Interact withother drugdevelopment professionalstoshareproblems,
concerns, experiences, andsolutions.
Explorecareer optionsinthepharmaceutical industry.
Thelaboratorymanufacturingexercisewill exactlysimulatethecGMP
manufacturingprocessfor Seromycin(placebo) runintheChaoCen-
ter for Industrial Pharmacy&Contract Manufacturing.
I nst r uc t or s

Professor G. Thomas Wilson graduated fromthe Purdue University
School of Pharmacy in 1975 and entered the practice of pharmacy. He
workedinindependent andcorporatelyownedpharmacies, includingbe-
ingstoremanager. HereturnedtoPurduethreeyears later towork and
teachinPurduesSchool of Pharmacy. Heserved20yearsasdirector of
experiential programs, duringwhichtimeheearnedhisJ.D. fromIndiana
University School of Law, Indianapolis. He was admitted to the Indiana
Bar in 1984. Since 1986 he has had sole responsibility for the jurispru-
dence course in Purdues School of Pharmacy. His responsibilities in-
cludeservingasliaisontotheIndianaBoardof Pharmacy. Inthisrolehe
isoftencalledupontodraft rulesandstatutes, manyof whichhavebeen
enacted. After nearly22yearsasamember of theAdministrativeProfes-
sional staff, Prof. WilsonacceptedatenuretrackpositionwithintheSchool
asassistant professor, thepost hecurrentlyholds.

Professor StephenR. Byrnis the Charles B. Jordan Professor at the
School of Pharmacyat PurdueUniversity, West Lafayette, Indiana. Heis
also head of the Department of Industrial and Physical Pharmacy. He
receivedhisB.A. degreefromDePauwUniversityandhisPh. D. degree
in chemistry fromthe University of Illinois, Urbana. He did postdoctoral
researchat UCLA. His researchfocuses onthesolid-statechemistry of
drugs. Prof. Byrnhas extensiveexperienceas aconsultant inthephar-
maceutical industryandcurrentlyservesontheCouncil of Expertsof the
USP, theDrugSubstanceTechnical Committeeof PQRI, andispast chair
of the Pharmaceutical Sciences Advisory Committee of the FDA. Prof.
Byrniscofounder of SSCI, acompanyprovidinganalytical chemistryser-
vicesandconsultation.

Michael Schmidt, Ph.D., graduated fromthe University of Wisconsin in
1964, andreceivedhisM.S. degreefromtheUniversityof Missouri School
of Pharmacyat KansasCityandhisPh. D. fromVanderbilt UniversityMedi-
cal School. Hewasapostdoctoral scholar at theNational Institutesof Health.
HethenjoinedEli Lilly andCo., wherehefirst workedas alaboratory re-
searcher andtheninanumber of management positions indiscovery re-
search, toxicology, andworldwidequalityassurancefor pre-clinical andclini-
cal drugs, andretiredfromEli Lillyin2000. Hehaspublishedover 50pa-
persandworkedwithnumerousscientificassociations. Post-retirement, he
consultsinthepharmaceutical industry, hasservedasaqualityandcom-
plianceadvisor toIndianaUniversity, andservesasaboardmember with
several science education and youth-serving organizations. Schmidt is
founder andpresident of Dr. BonesEducationIndianapolis, Inc., whichisa
scienceeducationoutreachcompany.

Guest lecturers. Guest lecturers (experts intheir field) will berecruited
by the course directors. Individuals will come fromacademia, industry,
andtheFDA.
ThecGMP courseaddresses fourareas.
FoodandDrugLawprovidesanoverviewof theorigins, structures, impacts,
andrelevanceof themany laws regulatingthemanufactureanddistribution
of drugs in the United States. The course will also focus on why different
regulationswereestablished, what arethemajor legal issues, andhowthese
legal issues shapeour regulations today. Theemphasis will beonthepur-
poseof thelawsandtheir applicabilitytodrugmanufacturing.
DrugDevelopmentaddresses drug discovery and drug development with
emphasisontheregulatoryaspectsof theseactivities. Thissectionisaimed
at providing a general background in pre-clinical research, clinical research
and chemistry, manufacturing, and control, or CMC. Animal pre-clinical re-
searchandhumanclinical researcharediscussed. Inaddition, thecontent of
the INDand NDAare discussed, along with the phases (I, II, III) of human
clinical research. The CMCaspects of drug development are summarized
alongwiththeICHdocumentsandpharmacopieal documents.
Desc r i pt i on of t he Si x -week Cour se
GoodRegulatoryPracticesincludes areviewof theregulations andhow
theyareimplementedintoqualitysystems, qualitycontrol polices, andqual-
ityassurancepolicies.
GMPManufacturingandLaboratoryexplainstheprinciplesof GMPmanu-
facturingandwill bepartiallytaught inthestate-of-theart GMPlaboratoryat
PurdueUniversity. StudentsintheGMPManufacturingandLaboratorycourse
will manufacture Seromycin or some other representative drug as an ex-
ample. Thecourseincludesdetailedreviewsof IOPs, SOPsanddocuments
usedfor GMPs, andincludes modules onfacilities andother GMPrequire-
mentssuchascleaningvalidation. Inaddition, hands-onlaboratorypractice
ispart of thiscourseusingcGMPtomanufactureSeromycin(placebo) using
batchrecordsSOPsandIOPsasrequiredfor thepractice.
Tui t i on and Fees
Tuitionandfeesfor thefirst two-weekprograminAugust, 2004, will
be $5000 per student. The tuition and fees for the four-week pro-
gramin2005will be$10,000per student. Housinganddinner fees
areinadditiontothetuitionfee. Seeregistrationform. Breakfast and
lunchwill beprovidedduringthetwo-weekcourseinAugust, 2004.
AbbreviationKey: GLPGoodLaboratoryPractices; GCPGoodClinical Practices; CMCChemistryManufacturingandControl; PATProcessAnalytical Technol-
ogy; SOPsStandardOperatingProcedures
Complete Six-week Training Program
CGMP Regul at or y Pr i nc i pl es
IntroductiontoMDR-TBProject, CourseIntroduction
FoodandDrugLaw
DrugDiscovery&DrugDevelopment
GLP, GCP
PlantTour
Monday
Tuesday
Wednesday
Thursday
Friday
Week 2 August 16-20
CMC, GMP
CMC, GMP
CMC, GMP
CMC, GMP
Exam; CourseAssessment; Local PlantTour
Week 1 August 9-13
CMC FilingandRegulatory
CMC FilingandRegulatory
CMC FilingandRegulatory
CMC FilingandRegulatory
CMC FilingandRegulatory
Monday
Tuesday
Wednesday
Thursday
Friday
Week 4 dat es t o be announc ed
Process Analytical Technology(PAT)PharmacyLaboratory
PATPharmacyLaboratory
PATPharmacyLaboratory; Pharmaceutical Engineering
PATPharmaceutical Engineering
Pharmaceutical Engineering; Exam; CourseAssessment
Week 3 dat es t o be announc ed
cGMP PlantOrientation; Analytical Methods; Validation;
Methods Validation
RawMaterial Release; PackagingSpecifications
RawMaterial Release; PackagingSpecifications
BatchRecords; SOPs
Hands onPreparationof asimulatedGMP batchinthe
ChaocGMP Center; AnalyzeProduct
Monday
Tuesday
Wednesday
Thursday
Friday
Week 6 dat es t o be announc ed
Hands onPreparationof asimulatedGMP batchintheChaocGMP
Center; AnalyzeProduct
Hands onPreparationof asimulatedGMP batchintheChaocGMP
Center; AnalyzeProduct
QualityReview; BatchRecordReview
CourseReview; SeromycinManufacture
Exam; CourseAssessment
Week 5 dat es t o be announc ed
Par t 1: Two-week c GMP Tr ai ni ng Cour se
Par t 2: Four -week c GMP Tr ai ni ng Cour se i n 2005