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PharmTech QMS presentation


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PharmTech's core Quality Mangement System, Product Life Cycle and Remediation services. Founded in 1995.

PharmTech's core Quality Mangement System, Product Life Cycle and Remediation services. Founded in 1995.

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  • Good morning.(Intro to topic and presenter)Although the discussion will include references to the pharmaceutical industry, the lessons learned and success are applicable to all industries and all functions of a company. PharmTech; 16 years QMS/Validation, as the needs of our clients changed, push for guidance of TnT, we evolved to address this is as well.Work with major pharma, food and medical device, FDA regulated industries, but we do take on projects with other industries that see value in our front end planning process.My background is in LT financial planning and Investment Banking. I’ve assisted startups, municipalities and established companies raise capital and advised them on how best to deploy it in their operations for business value and ROI. At PharmTech on Traceability initiatives, we do the same…we identify where additional business value and ROI can be found within your supply chain, operations and processes.As a disclaimer, we are technology agnostic. We are also solutions provider neutral. The clients needs and the infrastructure they have in place are what determines what the solution we recommend they implement.This will NOT be a Technical conversation (edge devices, GLN selection, integration with ERP) rather focused on ROI and Biz Value (Ken quote).
  • Going back to our roots 16 years ago, we built our name and separated ourselves by squeezing ROI and financial benefit out of projects that were only viewed as regulatory. In the Validation world we were like BASF, we didn’t make the process, we made the process better.
  • With most of our initial projects we aren’t going in asking them to let us in and spend millions on our services. We typically enter in on small projects and grow from there. We go in looking for a long term relationship as the value of our services become apparent.
  • Transcript

    • 1. Quality & Life Cycle Management
    • 2. Core Services
      Workflow Management Program Services Strategic Solutions CAPAValidation Business Value
    • 3. What We Do
      “PharmTech turns a cost into an investment.”
    • 4. About Us
      • Established in 1995
      • 5. Emphasis on FDA compliance and regulated industries
      Pharmaceutical, Medical Device and Biotech
      • Headquartered in Libertyville, Illinois
      • 6. Employee Owned ESOP
    • Our People
      • Management/PMs average 10 years experience
      • 7. Associates average 6 years experience
      • 8. Permanent staff iscomprised of
      • 9. ASQ Certified Quality Auditors
      • 10. Certified Supply Chain Professionals (CSCP)
      • 11. Quality Engineers and Managers
      • 12. IT personnel
      • 13. 4-year technical degreed professionals
    • Our Clients
      • Primarily Fortune 100 clients
      • 14. 100,000 + hrs compliance services in 2008-2010
      • 15. >75% repeat business
      • 16. Approximately 50% projects > 5,000 hrs
      • 17. Current projects in California, Georgia, Illinois & Texas
    • Partnering Benefits
      Subject Matter Experts
      Led remediation of CAPA initiatives
      FDA Audits
      Third Party Audits
      16 Years in Pharmaceutical Manufacturing as a Validation Provider
      Created and Implemented Audit Programs
      (Policy, Master Schedule, Execution and Resolution)
      Nationwide access to resources
    • 18. Achieve Full Regulatory Compliance
      FDA 483 and Warning Letter Action Plans and Remediation
      Corrective and Preventative Action (CAPA) Systems
      Methods & Process Validation
      Auditing and Gap Analysis (GXP, ISO, QSIT)
      Supplier Assessment, Management & Improvement
      Clinical Operations
      CFR parts 11, 210, 211, 820 and ISO 13485 and ISO 14971
    • 19. System Expertise
      • cGMP Compliance
      • 20. Process Utilities/Process Equipment
      • 21. Quality Assurance Documentation
      • 22. Computer Systems/Automation (PLC/DCS)
      • 23. Database System Design
      • 24. Facility Design Criteria
      • 25. Cleanroom/HVAC Design
      • 26. Construction Management
    • Client Benefits
      • Diversified Technical Resource Pool
      • 27. Experience-Based Knowledge
      • 28. Solutions/Results
      • 29. Lower Project Cost
      • 30. Resource Planning Flexibility
      • 31. Additional Resources
      • 32. Best Value & Quality Service
    • The PharmTech Advantage
      • Manufacturing/cGMP Experience
      • 33. Established Network Relationships
      • 34. Flexible Fee Structure
      • 35. Customized Protocol Formats
      • 36. Technical Capabilities
      • 37. Turnkey Capabilities
    • Why PharmTech?
      Project Leadership & Innovation
      Credentialed: 16 year track record in Pharmaceuticals
      Founded Traceability Solutions Group
      Cost Effective: Lump Sum Proposal
      Budget and project clarity from day 1
      We Live in Your Space with an emphasis on;
      Facilities, compliance, equipment and process
      History of delivering ROI
      We don’t talk about value, we find it!
    • 38. Next Steps…
      Michael Stewart
      Traceability & Supply Chain Visibility
      Direct (847) 281-8924
      Cell (815) 403-8425
    • 39. Technology Integration
    • 40. Technology: Areas of Focus
      Software Validation
      Process Automation and Optimization
      Computer Systems Validation (CSV)
      Documentation and Record Keeping
      Workflow Management
      Business Analytical Tools
      Part II of Electronic Records and Electronic Signature Requirements