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ISPE New Jersey Chapter Professional Development Day March 20 th,2014.

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Presentation on theme: "ISPE New Jersey Chapter Professional Development Day March 20 th,2014."— Presentation transcript:

1 ISPE New Jersey Chapter Professional Development Day March 20 th,2014

2 Today’s Discussion Points 2 Serialization Definitions and Drivers 1 Compliance Strategy 2 Operational Governance 3 Deployment Strategy 4 Early Lessons Learned 5

3 SERIALIZATION DEFINITIONS & DRIVERS 3

4 Business Drivers 4 Patient Safety: Insure the integrity of pharmaceutical products throughout the supply chain –Counterfeiting deterrent –Deter re-introduction of stolen goods into supply chain (with T&T) –Allows “Authentication” through the supply chain –ePedigree – confirmed movement through legitimate supply chain Compliance: Increasing regulations (US and Global) –US legislation: requires ePedigree with pathway to Track and Trace. Unit level serialization by Nov –EU Falsified Medicines Directive: requires serialization and tamper evidency in ~2017/2018 through EU country delegated acts (with pharmacy authentication) –Emerging Markets: (Argentina, China, Turkey, India, etc.) have enacted Serialization regulations typically requiring Trace & Trace

5 Definitions: Regulatory Impact on Operations Serialization  Applying a unique identification code to the retail unit of sale Track and Trace  Determining the location of product as it moves through the supply chain ePedigree  Documenting the chain of ownership of the product as it moves through the supply chain Aggregation and Inference (required for T&T)  Every item, case and pallet is assigned a serial number  Items are aggregated to cases (parent / child relationship)  Cases are aggregated to pallets  Unit level serial numbers can be “inferred” by reading the case or pallet serial number Authentication  Confirming the authenticity of the unique identification code, typically at the point of dispense GS1Standards 5

6 COMPLIANCE STRATEGY 6

7 Compliance Strategy 7 Included as one component of a comprehensive supply chain security program Work with industry groups to understand and help develop standards and influence the approach (e.g., PhRMA, EFPIA, GS1, Rx 360) Market alignment process to clearly understand the requirements for successful deployment Understand the global landscape to minimize impact to your design strategy Tracking SKU compliance

8 Market Compliance Enablement Market GL&S Market Serialization PMO Supply Network Enabling WS BT Enabling WS External Supply Enabling WS Market Enabling WS Logistics / SC Enabling WS Market Artwork BU Mgt Market Mfg Market Reg. Affairs Market Enabling Core Team Monitoring EvaluationEngagementEnablement Compliance Management Business as Usual Activity: Actively monitor mandates Monitor in program local solution Monitor in program enterprise solution for requirement changes Activity: Determine initial scope and sourcing strategy for mandate Document mandate compliance milestones Request and approve program funding Initiate market engagement Activity: Form local market team and meeting cadence Finalize approach and design for scope Update Enterprise master schedule to include identified enablement activities Activity: Coordination of schedule and resources Enable impacted Pfizer supply chain Enable data management across Pfizer supply chain Enhance Enterprise solution Activity: Onboard SKUs within the network Monitor and track SKU onboarding / compliance Activity: Transition supply chain and enabling functions to standard operational activity Ongoing monitoring

9 External Internal Enterprise Solution Local Solution Global Landscape 9 LSP (O2C WH) In-house (WMS WH) Serialized Products from Mfg Non-Serialized Products from Mfg Serialization Data to/from Site Lines Data Updates from Plant WH (including tracked shipments) Data Updates Internal Serialized Product Data EU Member Markets Phasing Lot – 2015 SN – 2017 WH – 2019 T&T – 2023 Authentication 2017 / 2018 Mandate Evaluation Non-Core Examples Distribution Serialized Product Data (Manual / Local BT Solution)

10 OPERATIONAL GOVERNANCE 10

11 Program Governance Executive Sponsor Program Governance Committee Supply Chain Security Program Operations PMO Steering Team PMO Program Leads Supply Network Enablement Capital Controls & Optimization BT Solution Enablement External Supply Enablement Logistics & Supply Chain Enablement Market Enablement & BU Engagement Program Financial Management Industry Alignment / Customer Engagement Day to day management of PMO Coordination of workstream activities Development of program metrics Oversight and guidance of PMO workstream activities Establish core solution strategies and scope Obtain funding for workstream resources Establish and monitor Program Deployment/Compliance Plan Stakeholder communication and awareness Endorse Program Deployment /Compliance Plan Endorse cost avoidance strategies (sourcing changes) Endorse investment deferrals and associated risks Participate in quarterly updates and elevate issues Corporate spokesperson Communicate business impact Elevate issues to Executive Leadership Team (ELT) End User Chg Mgt & Training Program Operations 11

12 Program Operations Steering Committee PMO GTS – GEPGS BTTradeGTS – PackagingGL&S Market Enablement Program Co- Leads Program Leads External Supply Program Co- Leads Program Financial Management CPA Allocation Oper Cost Impacts Operational Budgeting, Forecasting & Accounting Industry Alignment / Cust Engagement E2E Pilots Industry Engagement Policy & Regulatory Influence Market Enablement & BU Engagement Country Engagement Market Regulatory Requirements Market Enablement Logistics & Supply Chain Enablement Global Process Mgt Logistics Deployments Supply Chain SKU Onboarding End User Chg Mgmt & Training “Operationalize” Serialization End User / Process Change Mgt CI Supply Network Enablement Solution Platform Architecture Site Line Deployments SKU Compliance BT Solution Enablement Data Management Architecture Solution Deployments MDM External Supply Enablement CMO Project / Relationship Mgt CMO Line Deployments CMO Funding Model Capital Controls & Optimization Capital Planning & Optimization Capital Funding & Controls Capital Reporting Program Operations Network Compliance Scope & Change Mgt Schedule Mgt Enterprise wide representation, participation and collaboration Matrix organization with defined and integrated roles and responsibilities Sourcing strategy for External & Internal site packaging lines 12

13 DEPLOYMENT STRATEGY 13

14 Deployment Strategy 14 Engage with Suppliers and Logistic Service Providers to create awareness, provide solution assistance and build capabilities Adapt work processes in line with Serialization and Traceability requirements on network supply and distribution strategies/practices Build Serialization and Traceability competencies throughout the network Establish flexible technical solution based on standards are deployable in modules Develop a master plan to track and achieve compliance

15 Operating Model 15 Monitoring EvaluationEngagementEnablement Compliance Management Business as Usual Program Operations Activity: Actively monitor mandates / regulations not in scope of program Monitor in program local solution requirement changes Monitor in program enterprise solution for requirement changes Monitor and bring back learnings from pilots Activity: Determine initial scope and sourcing strategy for mandate Document mandate compliance milestones Request and approve program funding Initiate market engagement Activity: Form local market team and meeting cadence Finalize approach and design for scope Update Enterprise master schedule to include enablement schedules from all workstreams impacted Secure site / source funding Activity: Coordination of schedule and resources Enable impacted internal supply chain Enable data management across internal supply chain Enhance Enterprise solution Lead change management and training across internal Supply Chain Transition to Enterprise support Activity: Onboard SKUs within the network Monitor and track SKU onboarding / compliance Activity: Transition supply chain and enabling functions to standard operational activity Ongoing monitoring Activity: Coordinate alignment of all workstreams to ensure successful mandate compliance Management of Enterprise schedule Report Program and mandate status Manage Issue and risks Monitor and track progress across all in scope mandates Manage program communications Manage program scope and financials *Phases may occur in parallel or cyclical nature

16 Deployment Strategy 16 Understand Regulatory Landscape  Markets Served – US, EU and Emerging Market (i.e. Argentina, China, India, Korea, Columbia, Brazil, etc) Product Portfolio vs. Line Allocation  Line Consolidation  Deferment Consideration Line Assessments  Process Flow/Mapping - > Alignment and application of appropriate Global Solution  Asset - Upgrade, Redeploy vs. New  Collection and management of Master Data  Artwork Change Management/Guidance Documents Impact on Supply Network

17 Packaging Line Serialization Packaging Line enabling prerequisites: 1.Delivery of required equipment (e.g., new labeler or case packer) 2.Developing SKU artwork 3.Compiling SKU master data (+50 elements / SKU) 4.Availability of Serialization Solution Partner SME 5.Availability of Serialization SME 6.Availability of BT Serialization SME 7.Availability of production window (3 to 6 weeks of downtime) SCT 17

18 Case Packer Cartoner Case Packer P/V A/P/ V Conveyor Online Serialization & Aggregation (blisters) Unit Level Serialization Case Level Aggregation Online Serialization & Aggregation Online Serialization Authentication blisters Case Packer Case Packer P/V Conveyor Cartoner Case Packer Labeller Case Packer P/V A/P/ V Online Serialization & Aggregation (bottles / vials) Case Packer Labeler Case Packer P/V Online Serialization Authentication bottles / vials 18

19 Case Packer Cartoner (blister) Case Packer P/V A/P/ V Conveyor Unit Level Serialization Case Level Aggregation Online Serialization & Aggregation Cartoner (blister) P/V Case Packer manual or semi-automatic case packing A/P/ V Conveyor Unit Level Serialization Postponed Aggregation Online Aggregation for high volume SKUs Postponed Aggregation for low volume SKUs (same site) Cartoner (blister) P/V Case Packer manual or semi-automatic case packing A/P/ V Conveyor Unit Level Serialization Postponed Aggregation performed at second site Vial Filling Brite Stock Postpone Serialization & Aggregation at second site Case Packer Case Packing P/V A/P/ V Conveyor Serialization & Aggregation Unit Serialization & Aggregation Alternatives 19

20 Supply Network Impact Site Warehouses Schedule based on serialized lines Manage serialized and non-serialized product Aggregation rework Sampling Track shipments Update serialization information in the SCT Site Warehouses Schedule based on serialized lines Manage serialized and non-serialized product Aggregation rework Sampling Track shipments Update serialization information in the SCT Serialization Supply Network Landscape 3 rd Party Contract Operations Extensive collaboration needed - understanding requirements and delivery Dynamic schedule: changing mandates and vendor readiness Agreement on commercial impact (COGS impact vs. funded capital) Opportunity to consolidate to fewer suppliers 3 rd Party Contract Operations Extensive collaboration needed - understanding requirements and delivery Dynamic schedule: changing mandates and vendor readiness Agreement on commercial impact (COGS impact vs. funded capital) Opportunity to consolidate to fewer suppliers 20 Sites Line 1 Line 2 Line 3 Line 4 Line 5 Line 6 Impact on Sites Capacity impact from deployments (3-6 weeks downtime) OEE impact Reduced agility for SKU movements between pkg lines Exception handling Impact on Sites Capacity impact from deployments (3-6 weeks downtime) OEE impact Reduced agility for SKU movements between pkg lines Exception handling

21 EARLY LESSONS LEARNED 21

22 Early Lessons Learned 22 Start Early – pilot early and often Do not underestimate complexity… especially information technology aspects Partner with your serialization provider and align on the deployment schedule Build technical and operational knowledge Keep your antennae up – don’t ignore changing signals Consider all impacts to your organization Develop tools and toolkits to enhance competencies through your organization Communicate, communicate, communicate – never too much

23 23 Mark Wessel Global Serialization Program Leader Global Technology Services Pfizer Global Supply


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