1. My expertise inImmunology/Cell CultureandMicrobiologyhasledtoa broadexperience base inquality
systemsandmanufacturingcontrol knowledgeforthe pharmaceutical industry. Ihave over22 yearsof
researchand qualitysystemsexperience including:sevenyearsof researchbasedexperiencein
microbiological andcell culture/immunological research andproducttesting;11 yearsof experience in
vaccine productionand supervisionof QualityControl testingandmanagement; andfouryearsof
experience consultingforthe pharmaceutical industry.
My pharmaceutical Industryconsultingexperienceincludes clientsinthe followingareas:
 Biological products, humanderived andrecombinant
 API,Drug Substance,DrugProduct
 Parenteral manufacturers
 Oral DeliveryProduct (Non-Tablet)
 503B CompoundingPharmacies
 Blood derivedbiological productmanufacturers
 Generationof QualitySystemdocumentsandproceduresforvirtual andotherpharma
companies
I have experience inthe followingareasof regulatoryoversight andconsulting:
 FDA regulationsandguidance
 cGMPs under21 CFR Parts210, 211
 FDA consentdecree forbiologicalsmanufacturer
 483 response andremediation
 Microbiological issues:assays,sterility,cleanroom, watersystem, classificationvalidationand
verification
 PreparationforPAIforvirtual pharmacompany
 EMEA regulationsandguidelines
 ICH guidelines
 ISOstandards
My specificareasof experience include butare notlimitedto:
 Production facilityenvironmental monitoringprogramqualificationunderconsentdecree
 Productionwatersystemvalidationforuse forAPImanufacturer
 Gap analysisandretrospective review of productproductionandtestinginresponsetomultiple
483s
 Deviations,non-conformances,OOS,OOT
 Formal trainingforminorand majorinvestigationsunderconsentdecree
 CAPA determination fromformal investigationprocesswithdocumentationandeffectiveness
check
 Reviewandupdate of samplinginstructionsforall production batchrecordsaspart of consent
decree remediation
 Batch record andtestingreviewinpreparationforproductrelease
 SOPgenerationforall qualitysystemsandformaterial management,productlife cycle for
virtual pharmaceutical companypreparingforfirstproductPAI.