PharmTech Inc. - Services Overview - Supply Chain

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  • We’ve taken that compliance experience and knowledge base and applied used it in ways to be creative value added to provide solutions to our clients
  • “ You are surrounded by simple, obvious solutions that can dramatically increase your income, power, influence and success. The problem is, you just don’t see them.” - Jay Abraham “ The winner is the chef who takes the same ingredients as everyone else and produces the best results.” – Edward de Bono Achieving our client’s success is the focus of our partnership through continuous improvement and performance optimization. Our approach is simple; we assess our clients needs, identify efficiency opportunities, and execute objectives while maintaining compliance.
  • Serialization--One of the most important foundational elements of the TnT program. Interconnected (interoperable)--System that can talk between companies. CA—major requirements are the two points above. FL—requires pedigree (not necessarily electronic) and no serialization required. FDA—serialization and interoperability is good—for now letting industry decide but will be going this way. 2015—deadline for CA. Breadth—a lot to do.
  • Your company has much to gain from the inter-connectedness the California law promises. Uninterrupted compliance: There seems to be too much. Want to make sure you don’t miss your compliance dates.
  • Compliance with California law is old news. Everyone knows you will have to be there eventually. And that the system you will implement will enable many opportunities besides pedigree generation. However, a big questions is where to work now. You want to put your time into improvements within your four walls which will give you more visibility. But improvements can also extend to the outside, provided you make them scalable and standard. The key is to be proactive in your approach. You want to build a quality process, which will in turn give you a quality outcome. So right now focus on the proactive elements to improve your operations, but be mindful that the same tracking system will eventually be required to do the reactive elements as well. Plus, proactive elements are much more likely to be accomplished within the next few years, as opposed to reactive ones, which may require industry adoption or buy-in in order to gain value. DC Process improvement is a wholely internal game, but can be helped by tracking product as it travels through. Proactive are things that are not mandated by law. Reactive are things that are mandated. (2015 ePedigree compliance) Vs. traditional view of proactive vs. reactive. If you set them up properly, the transitions is quicker and easier than if you set them up separately. This references mandated vs. voluntary definitions.
  • Try to bring them closer in the future. Concrete departmental goals. Create the system you want, rather than something that is created for you. Personal visibility. Longevity. Notoriety. SME, Industry leader/reputation.
  • Training, Consulting, Evaluations Mapping and Gap Analysis in: Distribution Center, Manufacturing, Packaging, API Manufacture. Process Optimization Long Range Planning, Scheduling, Budgeting, Equipment Evaluation Impact Assessments, Efficiency Evaluation, Remediation Projects (?), Project Management, Support Services, Specialized Personnel Supply, Quality Policy Audits Metrics Definition, Post-Project Audits, Report Generation, Presentation Services
  • PharmTech Inc. - Services Overview - Supply Chain

    1. 1. PharmTech Inc. INNOVATE + COLLABORATE = SUCCEED PharmTech, Inc.
    2. 2. About Us <ul><li>Established in 1995 </li></ul><ul><li>Emphasis on FDA regulated industry </li></ul><ul><li>An Employee Owned Company </li></ul><ul><li>Primarily Fortune 100 clients </li></ul><ul><li>82% repeat business </li></ul><ul><li>Management/PMs average 10 years experience </li></ul><ul><li>Associates average 6 years experience </li></ul><ul><li>2008, PharmTech, Inc., All Rights Reserved </li></ul><ul><li></li></ul>
    3. 3. <ul><li>Focus on our clients’ success! </li></ul><ul><li>Understand client’s operations thoroughly </li></ul><ul><li>Identify ways to bring new value to their existing processes </li></ul><ul><li>Propose solutions to optimize performance </li></ul><ul><li>Work together to achieve successful results </li></ul><ul><li>2008, PharmTech, Inc., All Rights Reserved </li></ul><ul><li></li></ul>Our Business Perspective
    4. 4. Quick Evaluation <ul><li></li></ul>
    5. 5. Quick review of TnT <ul><li>Serialization </li></ul><ul><li>Interconnected electronic system </li></ul><ul><li>California and Florida </li></ul><ul><li>FDA perspective </li></ul><ul><li>2015 </li></ul><ul><li>Breadth of work </li></ul><ul><li>2008, PharmTech, Inc., All Rights Reserved </li></ul><ul><li></li></ul>
    6. 6. Challenges to TnT in your Company <ul><li>Proving Necessity </li></ul><ul><li>Unknown Processes </li></ul><ul><li>Un-Defined Requirements </li></ul><ul><li>Breadth of Changes Required </li></ul><ul><li>Amount of Work Ahead </li></ul><ul><li>2008, PharmTech, Inc., All Rights Reserved </li></ul><ul><li></li></ul>
    7. 7. Long-Term Company Gains <ul><li>Uninterrupted Compliance </li></ul><ul><li>Streamlining and Upgrading </li></ul><ul><li>Internal and External Process Visibility </li></ul><ul><li>Supply Chain Visibility </li></ul><ul><li>2008, PharmTech, Inc., All Rights Reserved </li></ul><ul><li></li></ul>
    8. 8. Work Now <ul><li>2008, PharmTech, Inc., All Rights Reserved </li></ul><ul><li></li></ul>Internal External Proactive Reactive Transport Audit Compliance Recall Management Cold Chain Anti-Counterfeiting API Tracking Diversion Control Supplier-Supplier Cycle Time Reduction DC Process Improvement Vendor Performance
    9. 9. Departmental Benefits <ul><li>Cutting Edge Process Improvement </li></ul><ul><li>No Rush to comply in several years </li></ul><ul><li>Build the system YOU want </li></ul><ul><li>Lasting impression on your company </li></ul><ul><li>2008, PharmTech, Inc., All Rights Reserved </li></ul><ul><li></li></ul>
    10. 10. PharmTech Services <ul><li>Knowledge Base </li></ul><ul><li>Process Evaluation </li></ul><ul><li>Execution Plan Coordination </li></ul><ul><li>Project Execution and Oversight </li></ul><ul><li>Success Criteria and Measurement </li></ul><ul><li></li></ul>
    11. 11. Knowledge Base <ul><li>Training </li></ul><ul><li>Consulting </li></ul><ul><li>Evaluations </li></ul><ul><li></li></ul>
    12. 12. Process Evaluation <ul><li></li></ul><ul><li>Process Mapping </li></ul><ul><li>Gap Analysis </li></ul><ul><li>Process Optimization </li></ul><ul><ul><li>Distribution Center </li></ul></ul><ul><ul><li>Manufacturing </li></ul></ul><ul><ul><li>API Tracking </li></ul></ul>
    13. 13. Plan Coordination <ul><li></li></ul><ul><li>Long Range Planning </li></ul><ul><li>Budgeting </li></ul><ul><li>Scheduling </li></ul><ul><li>Equipment Evaluation </li></ul>
    14. 14. Execution Oversight <ul><li></li></ul><ul><li>Impact Assessments </li></ul><ul><li>Efficiency Evaluation </li></ul><ul><li>Remediation Projects </li></ul><ul><li>Project Management </li></ul><ul><li>Support Services </li></ul><ul><li>Specialized Personnel Supply </li></ul><ul><li>Quality Policy Audits </li></ul>
    15. 15. Integration Services <ul><li></li></ul><ul><li>Usage Audits </li></ul><ul><li>Report Generation </li></ul><ul><li>Presentation Services </li></ul><ul><li>Adoption Monitoring and Support </li></ul>
    16. 16. Points to Remember <ul><li>Business Value Opportunities </li></ul><ul><li>There is a lot of work to be done </li></ul><ul><li>Proactive rather than Reactive </li></ul><ul><li>PharmTech can help! </li></ul><ul><li>2008, PharmTech, Inc., All Rights Reserved </li></ul><ul><li></li></ul>

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