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Project Delta – GPO Quality AssuranceRegional Operating Model
December 7, 2006
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Project Delta – GPO QA Regional Operating Model
A competitive advantage is the capacity to reinvent your business model before circumstances force you to.
The QA regional model has been developed to:
– Manage quality within GPO– Ensure appropriate compliance (local requirements) at a market
competitive cost, – Utilize flexible and adaptable Quality systems / processes, and– Foster and recognize talent in a performance based culture
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Project Delta – GPO QA Regional Operating Model
• Drive transformational change that creates a best-in-class Quality organization capable of competing in a highly cost competitive and dynamic pharmaceutical manufacturing environment.
• Goal is to:
– Develop a Quality System operating model and organizational structure that is flexible and adaptable to changing business needs while fostering and rewarding strong individual performance.
– Ensure the services, talent and accountability are at the optimal level in the organization to drive business value.
– Ensure appropriate compliance to local requirements at a market competitive cost.
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Project Delta – GPO QA Regional Operating Model
• Move from a centralized to a more decentralized (Regional/ Plant) model.
• Ensure that truly global business initiatives and strategies are managed by Global Division.
• New model best supports our business needs
– Within 5 years 88% of PPG’s products will be competing for market share with generic competition
– Increasing cost competitiveness among pharmaceutical manufacturers– Growing pressures on healthcare costs– Rising expectations from regulatory agencies– Need for further clarity of roles and responsibilities within GPO QA
• New model is similar to those operated by J&J, Novartis and is currently being rolled out by GSK.
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Regional Operating Model
Region 2
Plant
D
Plant
EPlant
F
Region 1
Plant
A
Plant
BPlant
C
Region 3
Plant
G
Plant
HPlant
I
Global Division
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GPO QA Regional Operating Structure
PAA
LA
Global Division
U.S./Puerto Rico
Abbott Park
NorthChicago
Wyandotte Whippany
Barceloneta Jayuya Ludwigshafen
Queen-borough
SligoSt. Remy
LiestalCampo- verde
Karachi
Goa
Katsuyama
Cimangis
Shanghai
Barceloneta
Worcester
Biologics
Mexico
Rio de Janeiro
Buenos Aires
Europe
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Project Delta – GPO QA Regional Operating Model
The expected benefits from Project Delta are aligned with Abbott’s core values:
• Pioneering
– Developing sustainable systems that drive compliance and quality by design
– Enabling a culture that provides tools and skills that drive innovation– Supporting a strong talent management program to provide
leadership for future business needs
• Enduring
– Adapting proactively to changing business and regulatory needs– Investing in our future (people and financially)
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Project Delta – GPO QA Regional Operating Model
• Caring
– Demonstrating mutual respect with our employees, business partners and the community
– Understanding everything we do is for the benefit of our patients
• Achieving
– Implementing meaningful ideas and improvements that add value for our customers and patients
– Creating a simplified business structure leading to clear roles, responsibilities and accountability
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Critical Success Factors
• Collaborative Leaders at all levels
• Change Management
• Implementation of Expert Councils
• Organizational Transformation
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Change Management
• A formal change management program is being implemented to facilitate the next steps of the transition to the regional model. The transition includes business processes, culture, talent management, organizational structure, roles, responsibilities and accountability.
– First change management session will be scheduled in Lake County in December, 2006.
– Change Management sessions will be made available to all regions and will be scheduled during 1st Quarter 2007.
• Program will include continuous communication and feedback to the Transition Team
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What are Expert Councils?
• Functional teams with representation across plants, regions and Strategic QA
• Responsible for:
– Liaison with CRQS– Policy Development– Quality System Process Improvements– Communication– Benchmarking– Best Practices– Consistency across plants and regions– Evaluation of industry and regulatory trends
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Expert Councils – Matrix Organization
Plant A
Plant B
Plant C
Region 1
Plant D
Plant E
Plant F
Region 2
Plant G
Plant H
Plant I
Region 3
Plant J
Plant K
Plant L
Region 4
Expert Councils
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Expert Councils
– Validation– CAPA– Complaints– Quality Engineering– Document Control – Training– Compliance– Microbiology/Environment
Monitoring
– Lab – Analytical– Lab - Stability– Distribution QA– Commercial QA– TPM QA– Supplier QA
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Expert Councils - Benefits
•Better Utilization of Resources
•Connection between plants/regions
•Knowledge Sharing/Benchmarking – Regionally and Worldwide
•Decisions and Initiatives at Appropriate Areas and Levels
•Continuous Improvement
•Development of Employees•Prevention of Quality Issues•Active Engagement by the Organization•Drive Consistency Where Needed Across Regions and Worldwide
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Expert Councils – Next Steps
• Identify Council members by subject, plant and region end of 2006.
• Training for Council members during 1st Quarter 2007.
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M ariann B runkerA dm in A ss ist
R o bert O 'H aganA B C Q A D irG risell G o m ezA B L QA M grR o lf R atkeM anagerH um ira D P , Q ualityDavid N es sR eg io nal S ervic es D ir
B ill G anzerD VP
B io lo g ic s R eg ion
J o rge R o c c atag liataA rgentina Q A D irJ unia R o driguesB raz il Q A D irF ranc isc o P erezM exico Q A D irJ ose A ntonio M artinezR eg io nal S ervic es D ir
L aura O benau fD irec to r
Latin A m eric a R eg ion
S unil A c haryaInd ia Q A M grC hunX iang W angC hina Q A M grF arrukh H afeezP ak is tan Q A D irT riyanti H uniyatiIndones ia Q A M grY oshie T akahashiJ apan Q A M grV inc ent C hangR eg io nal S ervic es D ir
J avier R iveraD irec to r
P A A / J apan R eg ion
M iguel C resp oQ A D irec torS ynthro id Q ualityS teve R itterW yando tte Q A M grLeila F uentesJ ayuya Q A D irR ick M o ssW hippany Q A D irN ancy L indse yA P L Q A D irB rian B raunLC Q A D irN ico las M aldonad oR eg io nal S ervic es D ir
J es us F ernandezD VP
U S /P R R eg ion
S tuart S tampU K Q A D irJ im O 'R eganS ligo Q A D irP aul- Lo uis G ayre lS t R em y, QA D irC laud io VergariC am po verde Q A D irL o rraine Tho m pso nL ies tal Q A M grU lric h B ec htL udw ig shafenQ A D irec torT odd C herm akD irec to rE U M o dernization& P ro jec t F o rw ardY vo nne F renc hR eg io nal S ervic es D ir
R oger DraperD VP
E uro pe R egion
K athryn W hiteD ir, C o m pliance& O peratio ns T rainingG ene G rac e yD irec to r,S trateg ic B us iness & P rojJ ody Vo ightD irec to r G P OQ A C o m plianc eO peratio nsT im S chuetterD irec to rG P O Q uality S ystems
S hirley K reutzfeldtD irec to r
Q A S trategic Initiatives
T im T omko vichK en L yonJ ac kie VeiviaJ o hn M argetsonP aula S tap lesF rank L im o nes
M arilyn F ro ntzD irec to r
Q A O rg T rans ition Team
B o b S tew artD VP
G P O G lobal Q A
GPO Global Quality Assurance
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R o bert O 'H aganA B C Q A D irec tor
G risell G o m ezA B L Q A M anager
R o lf R atkeM gr, H um ira D P Q uality
C arla A lo ng iG lo bal C hange C o ntro lD em etra M ac herasG lo bal C hange C o ntro lB rian H o ffm anC A P A S pec ialistP am W arlandR egulato ry C o m plianceJ o n O g leT P M Q A
D avid N essR egio nal S ervic es D ir
B ill G anzerD VP
B io lo g ic s R eg ion
Biologics Region
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J o rge R o c c atag liataA rgentina Q A D ir
J unia R o driguesB raz il Q A D ir
F ranc isc o P erezM exic o Q A D ir
Ivan T o rresQ uality E ng inee rD eanne S tahlM gr, C o m m QA /D is trJ us tin S traubQ uality P ro j M grL ydia V la isavljevicM gr, T P M S /A ud it
J o se A nto nio M artinezR eg io nal S ervic es D ir
L aura O benaufD irec tor
Latin A m eric a R eg ion
Latin America Region
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S un il A c haryaInd ia Q A M g r
C hunXiang W angC hina Q A M g r
F arrukh H afeezP ak istan Q A D ir
T riyanti H uniyatiInd ones ia Q A M gr
Y oshie TakahashiJ ap an Q A M gr
J o J o M unjiTP M Q AO m ar R iya lC omm erc ia l Q A /D is tribC hris To rkelsonQ uality E ngineer
Vincent C hangR eg io nal S ervices D ir
J avier R iveraD irec to r
P A A /J ap an R egion
PAA/Japan Region
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M iguel C res poQ A D irec tor
S ynthro id Q uality
D avid H illC o mp laince M g r.
B rian H intzQ C Lab M gr.
S teve R itterW yando tte QA M anager
E rick N ievesQ A O ps M gr
C armen To rresC o mp liance M g r.
E ve lyn S anc hezQ C L ab M gr
R amo nita R o d rig uezC o mp lianc e Offi c er
Ivan F lo resC o mp lianc e Offi c er
L e ila F uentesJ ayuya Q A Direc tor
R ay B as tianM fg Q A M gr.
F rank Ad airM ic rob io log y M g r.
A m y J o hnsonQ C Lab M gr.
S ind y F o s terT raining & C o mp liance M g r.
J anie W allaceD o c umentatio n M g r.
R ick M o ssW hip pany QA Direc tor
M aria A. G arc iaP lant Op s . QA M anagerA P L F G O p eratio ns
P aul H els tromP lant Op s . QA M anagerA P L A P I O peratio ns
Y anira C olonA P L QC L ab M gr
C armen M o ntalvoA P L C o mp lianc e M gr
N anc y L inds eyA P L Q A D irec tor
M ark K ap pelP lant Op s . QA M anagerA P F G O p eratio ns
L arry M illsP lant Op s . QA M anagerN C A P I O peratio ns
M ike B eaumo untL C QC Lab M gr
P at Deason- B ied ronD o c M anag er FG
R o bin C o meinEnvironmental M gr
M agd a VegaM anagement R eview
A m y S c hulteC o mp lianc e Q A M grN C F G Op eratio ns
B rian B raunL ake C o unty Q A D irec tor
M ridula M enonM anagerP D M A C omp liance
N elly M ilmanC o mp lianc e M anag er
P hyllis Sed arS upp lier / TP M Q A D irec tor
J ulie S m ithL abel C o ntro l M anager
L arry R ho desM anager, S tab ility S ervic es
N ico las M aldo nadoR egio nal S ervic es D ir
J esus F ernand ezD VP
U S /P R R eg ion
US / PR Region
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J ay M c G uffinJ ulie R utherfo rdL inda W ro be l
J aim e A bregoA na B us tosH ec to r C lem enteM elis s a G o ngo raDo nna W infrey
N athan H illL abel E d ito rP ro o freader S up
L uke J ac o bsenM artha L o pezB en O ndoM elba A yala (A I)K o nnie O s bo rn (A I)
M ic hael F reebo rnG raphic s /A IL abeling S u p
D ina D o rrC indy Y eldo n
J ulie S m ithL abel C o ntro l M gr
J ac queline P eterso nR is a B aldy
A ndrea N o fs ingerP atric ia W ellerS arley H allP atric ia F rank linB rian D ietz
D o m inique K endric kC o m plaints S ec tio n M anager
M arge D ietric hJ eff H ulbertL arry M axw ell
L uis R o salesC hic ago D C M anager
P hil Zac h
N elly M ilm a nC o m p liance M anager
J udy Em m ertF rank W agnerD ebb ie W hits o nJ ulie W ebe rT o ni U rib eG ary D anc aM arilyn G arbarinoN ic o le J eanb lancK aren M agnus o nL uis N ieve s
L aura J o hnso nD o n S c haeferM ike Z ielke
S teve D alton
P edro R iveraT P M C E P HE li C o lo nT P M C E P H
B o b B o w m anG ail P rattJ im M o ggedJ ill F eldm an
A ngela K elleher
P hyllis S edarS upp lier / T P M Q A D ir
M aria L aF leu rQ A P ro jec t M grT o m H uskeC o m plianc e A nalys t
M ridula M eno nP D M A C o m plianc e M gr
C . V ilayc hac k
E va P ihuelac
D ebbie E gger
D ana A n
E ric W ardJ o hn R iveraDo ug N els on
M ike K ap lan
J o c elyn C adyR ic k O rtizW alter R o uthD o nna S antuc c iS haro n P ierce
L arry R ho desM gr, S tab ility S ervice
N ic o las M aldonad oR eg io nal S ervic es D ir
U S / P R R eg ionL ake C o unty
US / PR Regional Services
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S tuart S tam pU K Q A D ir
Jim O 'R ega nS ligo Q A D ir
P au l-Lou is G ayre lS t R em y Q A D ir
C laud io V ergar iC am poverde Q A D i r
Lorraine T hom pso nLiesta l Q A M g r
U lrich B ech tLudw igsha fen Q A D i r
T odd C herm a kD irecto r
E U M ode rnizatio n& P ro j F orw ard
T heres a Jone sQ A S erv ices M g rT esh P ate lC om m ercia l Q A M g r
B rian B ackT P M EUE m m a M c E voyT P M EUM arkus H useT P M EU
D avid N ess (In terim )S upplie r/T P M Q A
Jose R am on S o laQ A M gr S painE ric de W itQ A M gr B red aE line van G ees tQ A M gr A LO GM arch e l M o lQ A M gr - LR P
E d H a rriga nLogistics Q A D i r
Y vonne F renc hR egional S erv ices D i r
R oger D rape rD V P
E urope R eg io n
Europe Region
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T eri D illonM an age rT ra in ing D e velopm en t
D ivya T rived iM an age rT ra in ing D e velopm en t
D av id R ausch enbergM anag er, Is o T ra in
K athryn W hiteD irec to r
C om plian ce & O p erations T ra in in g
M arcell R e idM an age rS upp lier E xce llenc e
D ave D olg inM gr. Q ua lificatio n
Loren zo G u tierre zM gr. V a lidatio n
D ave U lric hS trateg ic D ist. Q A
P aul W hitso nQ uality E ng inee r(L iestal )
F eroz P ardes iQ ua lity E nginee r
Lessa B utle rQ uality E ng inee r
D ave B oebe lQ ua lity E nginee r
R oge r R athund eQ uality E ng inee r
Janet A ndreQ A P rogra m M a nage r
M arc G ree nfieldQ A P rogra m M a nage r
A nna Lau ra S avellaQ A P rogra m M a nage rLocated - C ampo verde , Ita ly
C athy Le eQ A P rogra m M a nage r
M ark S atte rQ A P rogra m M a nage r
G ene G race yD irecto r
S tra tegic B usiness a nd P ro jec ts
G reg K aste rC om pendia l S erv ices /R efere nce S ta ndard s
F rank K ra jac icR isk A ssessm ent/B S E T SE
P at C arne yM gr In terna l A udi t
G abrie la W hipp leP ro jec t M g r
G ary N ova kG P O P o lic y M anage r
T im Y ostC om plianc e
M arg e F reun dC A PA
Linda B rucher tR ecord R eten tion/P ro tectio n M rg .
K en Jo hnso nP rog ram M an age r
Jody V oigh tD irec to r
Q A C om plia nce S ervice s
D ebra B arte lIT P lanning/S erv ice s
A m y D aw so nP rog ram M an age rG lobal D oc T rans form atio n
C arla R esc hM an age rQ ua lity A ssuranc e D ocum entatio n
K eith R ichte rG Q M S P rogra m M g r
A donna P h ilip pV M S P ro gram M g r
W endy D o nQ A C om plain t P rog M g r
T im S chuette rD irecto r
Q ua lity S ystem s
S hirley K reutz feld tD irec to r
G P O Q AS trateg ic In itiative s
Strategic QA
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Strategic QA - Training
K en J urane kK irk R o b erts o nC hris S c hro d e rS and ra V illa rrea l
T eri D illionM gr. T ra in ing D evelo pm en t
L isa M endoz a
D ivya T rivedM gr. T ra in ing D evelo pm en t
M itchell G oldm a nG elsom ina Is enberg
D av id R ausch enbergM anag er, Is o T ra in
K athy W hiteD irec to r
C om plia nce an d O perations T ra in in g
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Strategic QA – Strategic Business and Projects
M ark S atte rQ A P rogra m M a nage rM arc G ree nfie ldQ A P rogra m M a nage rA nna Lau ra S avellaQ A P rogra m M a nage rLocated - C am po verde , Ita lyC athy Le eQ A P rogra m M a nage rJanet A ndreQ A P rogra m M a nage rP aul W hitso nQ uality E ng inee r(L iesta l )F eroz P ardes iQ uality E ng inee rLessa B utle rQ uality E ng inee rD ave B oebe lQ uality E ng inee rR oge r R athund eQ uality E ng inee r
A nne W arnk e
M arcell R eidM an age rS upplie r E xcellenc e
K eri M uldoo n
R ob S w obod a
W aunetka C la rk
D ave D o lg inM gr. Q ua lificatio n
M ary Z orcM ichelle H aine sP eggy B u s tam anteJill T ay lor
Loren zo G u tie rre zM gr. V a lidatio n
C herry l C ho i
D ave U lric hS tra teg ic D is t. Q A
G ene G race yD irec to r
S trateg ic B usiness a nd P ro jects
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C aro le B oundsK im Tho m asM arc ella P ierreDeW ayne H arm onN icole A lfaroK aren T ug g leS teve G reg o ry
B arb DeW ald
L ind a B ruc hertR ec ord R et/P ro tec tio n M gr
G reg M athieuC o m p end ia l S M EE d S hadaC o m p end ia l S M E
M o nika P elletierM argarita S alazer
T heo Ko llieR ef. S tds
W illiam M yintW e-S ing C hang
T o d d M artingF anho ng Zeng
B rian C ao
M ayra A b renica
G reg K as terR eferenc e S tand ards
C o mp end ia l M gr
R ac hael M o o reA p ril H eis ler
G abrie la W hip p leP ro jec t M gr
J o hn C ap elliL o uisa G ac ekC o lleen M cK enna
G ary N o vakP o licy M anag er
W ayne H eitm annM aha N o uje imeD rag an O b rad o vich
P at C arneyM g r. Internal A ud its
A rd rene Y anc eyR eg ulato ry C o mplianc e (B S E/T S E)
J ennifer S c hneller
F rank K rajac icR isk A ssessm ent / T S E /B S E
T im Y o stC o mp liance
C heryl B arano w skiK ara S m ith
M arg e F reundC A P A
K en J o hnso nP ro gram M anag er
J o d y Vo ig htD irec tor
Q A C o m pliance S ervic es
Strategic QA – Compliance Services
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Strategic QA – Quality Systems
Lo rilee A dams
K en N elso n
Lynn S tried
A liso n R o tsch
C o nnie To lpp i
J im C o c kerillLynn B less ing
L aura A m ayaJ ac k B as eley(H o ng) T ina P engN ina S tein
S co tt R as mus sen
T erri R ach
F red T est
L isa W hite
K en W eber
D ebra B artelM gr. Q uality S ys temsIT P lanning & S ervices
J udy C arlso nR ay H erm anE s senc e L inds a yVirg inia P etro
J o hn B atesXM L P rojec t M gr
A ngela S m ithQ M D P rojec t M grK elly S erafiniP ro ject M gr
M arc ia P earson
R uss R ederQ M D D ep lo ym ent
D ebb ie S c hnide rQ A P ro jec t M gr
A m y D aw s onP ro gram M gr
G lo bal D o c T rans
W anda C o llin s
B o bb ie M o rrisInt. D o c S pec ialist
D aw n B arc zakB ill C o nle yC raig S m ithL araine D elahantyJ ud ie H oenigM arty L aw les sM ary P ecT ho m as W hitbeck
B rynn S c handerC hange C o ntro l M gr
B rian A frylJ ulitta C ebrzynskiInge H am m o ndL iz H els tadS hanno n J ohns onL o uis e L ew isT ho m as M arkusJ udy P res tayT am my R ym erM arc ia VavrekB o bb ie G riffin
A lm a B aileyD o c um ent S upervisor
A l H artm anM gr, Q A D o c C enter
C arla R esc hM anager
Q uality A ss uranc e D o c um entation
K eith R ic hterG Q M S P ro gram M gr
W endy D onC o m p laint P ro g ram M gr
Shaun tea To lliver-Denton
A do nna P hilip pVM S P ro gram M gr
T im S chuetterD irec tor
Q uality S ystems
28
T im T o mk o vich
K en L yon
J ac k ie V e ivia
J o hn M arg ets on
P aula S tap les
F rank L im o nes
M arilyn F ro ntzD irec torG P O Q A
O rg anizatio na l T rans itio n T eam
QA Organizational Transition Team
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Project Delta – GPO QA Regional Operating Model
• We will continue to drive transformational change that creates a best-in-class Quality organization capable of competing in a highly cost competitive and dynamic pharmaceutical manufacturing environment.
• We will have an organization and culture that prides itself on:
– Solid execution– A simplified business model– Efficient business processes (quick, flexible, effective)– Right balance of resources with compliance risks– High performing workforce– Clear accountability
