Pharm tech core traceability presentation
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PharmTech is a company that provides track and trace and serialization solutions for pharmaceutical and medical device clients. They have experience implementing traceability solutions globally since 2007. Their services include assessing business needs, developing traceability strategies, planning implementations, and ensuring solutions deliver ROI through improved supply chain visibility and business process optimization. They take a holistic approach to help clients meet regulatory requirements while gaining additional business benefits.
Pharm tech core traceability presentation
- 2. Core ServicesWorkflow Management Program Services Strategic Solutions CAPAValidation Business ValueTechnologyIntegrationTraceabilitySystemsROIQuality Management Systems
- 3. What We DoâPharmTech turns costs into investments.â
- 4. About UsEstablished in 1995
- 5. Emphasis on FDA compliance and regulated industries Pharmaceutical, Medical Device and Biotech Headquartered in Libertyville, Illinois
- 6. Employee Owned ESOP
- 7. In 2007 we focused our activities to address concerns of pharmaceutical clients on U.S. & Ex-US regulatory guidelines surrounding Track & Trace.Our PeopleManagement/PMs average 10 years experience
- 8. Associates average 6 years experience
- 10. ASQ Certified Quality Auditors
- 11. Certified Supply Chain Professionals (CSCP)
- 12. Quality Engineers and Managers
- 13. IT personnel
- 14. 4-year technical degreed professionalsOur ClientsPrimarily Fortune 100 clients
- 15. 100,000 + hrs compliance services in 2008-2010
- 17. Approximately 50% projects > 5,000 hrs
- 18. Current projects in California, Georgia, Illinoisand TexasGlobal MandatesTurkey Item Level Serialization June 2009Serbia August 2009Turkey Aggregation June 2010France CIP13 , 2D Bar Code January 2011Columbia January 2012Brazil GS1, 2D Bar Code, Labels January 2012Spain 2D Bar Code 2012Italy 2D Bar Code 2012EU Package Serialization January 2014US- CA Serialization & E-Pedigree January 2015
- 19. Traceability: Whatâs behind it?Patient SafetyTraceability assists in; Recall Management
- 20. Diversion
- 21. Counterfeit
- 22. Reimbursement
- 23. TheftIdentifying Business ValueâLife Science leaders are looking at these regulatory requirements as an opportunity to improve business process and operations, enhance patient safety and protect the brand.â-HussainMooraj, AMR ResearchâPharmaceutical Focus 2011: Supply Chainâ Eyefortransport
- 24. ROI is EverywhereReducing Days on Hand InventoryRecall ManagementDemand PlanningEnd to EndReal Time TrackingAnti CounterfeitingROICycle Time BalancingVendor Managed Inventory (VMI)Improved Asset UtilizationProcess StandardizationCash Flow ManagementChargeback ManagementImport Process MonitoringLot Restriction ApplicationPerfect OrderTrade Promotion OptimizationProcess Modeling & SimulationsGood Distribution PracticesDiversionPlanning, Production & LogisticsShelf LifeCold Chain Monitoring
- 25. Immediate ROI OpportunitiesAsset Visibility, Tracking & UtilizationIssue Resolution and OpportunitiesReal Time ResponsePedigree & Authentication CaptureLeverage Captured Data for Improvements in; Sales & Marketing Inventory Control Logistics Workflow Processes Cash-to-Cash Perfect OrderRecall ManagementIdentification of Diversion & Counterfeiting
- 26. Planning for Business Value
- 27. Phase 1: StrategyProcess Mapping
- 29. Gap Analysis
- 30. Current State/Future State Evaluation
- 31. Time and Motion Studies
- 34. Phase 2: PlanningImpact Analysis
- 40. Long Term Planning & Forecasting
- 42. Phase 3: ImplementationImplementationProject Management
- 43. GS1 Conversion
- 44. Internal Test & Validation
- 46. PilotingEnd to End VisibilityChallenge:Pharmaceutical manufacturer had near zero visibility into their supply chain.
- 47. Concerned with forthcoming regulatory requirements.Scope of Work:Pilot serialization program to understand;
- 48. Data usage
- 49. implementation timeline & costs
- 50. line impact and required inventory buildEnd to End VisibilityResults:Dashboards, Metrics
- 51. Trading Partner data share
- 52. Visibility of Actual Demand
- 53. Budget clarity
- 54. Compliance architecture in place
- 55. Reduction in inventory and ingredient costs
- 56. End to End integrationReal World : Real ValueWith increasing costs of drug development, finding ways to boost market share of existing branded drugs which have gone off patent was of prime concern, as branded drugs have higher premium than competing generics.Challenge:Flat sales and generic equivalents
- 57. Current system too costly.
- 58. Need serialization compatibilityReal World: Real ValueResults:Serialization mitigated future regulatory concerns
- 60. Automated software for dispenser,
- 61. Direct billing
- 63. Scheduling
- 64. 3% increase in overall market share
- 65. Extensible to other products and divisionsGoing Beyond a Traditional Serialization PilotPharmaceutical manufacturer wanted to know what manufacturing technology solution, standards and process changes would be needed to deal with serialization of a product.Challenge:New technology assessmentStandards ConversionUncertain regulationsLimited budgetScope of Work:Proof of concept Advised client to incorporate additional
- 66. Going Beyond a Traditional Serialization PilotBusiness Value Highlights:Original purpose successful In addition, without additional piloting costs:Proved viability of authentication
- 70. Influence industry direction Reduce Days on Hand InventoryChallenge: Need to reduce Days on Hand (DOH) costs associated with excessive inventory in the wrong locations.Business Value:Near real time supply chain view of product in progress and historical data.Monitoring of key process changes as they occur, expediting the confirmation of the enacted improvements Reduction in site specific inventory to match production level demandDecrease in manufacturing times
- 72. Traceability PlanningPharmTechTraceability ReadinessAnalysisCustomized Traceability Solution
- 73. TraceabilityPlanningMaking Sure ThatThe Solution Is Interoperable With Existing SystemsCustomized Traceability SolutionClientERPBusiness ProcessesCustomized Traceability SolutionCultural FeaturesEx-US OpsThird Party Relations
- 74. The Traceability SolutionBUSINESS VISIONProvide âReal Timeâ internal and external visibility, meeting Global Supply Chain objectives through integration of global traceability standards and technology. BUSINESS PROCESSESEnable new and accurate sources of information from the extended supply chain for improvement of productivity and performance.TRACEABILITY APPLICATION Integrates event information derived from desired data sources in the distributed supply chain, displaying business activity and intelligence in a dashboard format.INFRASTRUCTUREBuilt on a standardized and secure foundation enabling delivery of event data for tracking forward and tracing backward the flow of product.
- 75. Why PharmTech?Project Leadership & InnovationCredentialed: 16 year track record in Pharmaceuticals Founded Traceability Solutions GroupCost Effective: Lump Sum Proposal Budget and project clarity from day 1We Live in Your Space with an emphasis on;Facilities, compliance, equipment and processHistory of delivering ROI We donât talk about value, we find it!
- 76. Next StepsâŚMichael StewartTraceability & Supply Chain VisibilityDirect (847) 281-8924Cell (815) [email protected]