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Quality & Life Cycle Management<br />
Core Services<br />Workflow Management Program Services Strategic Solutions CAPAValidation Business Value<br />Technology<...
What We Do<br />“PharmTech turns a cost into an  investment.”<br />
About Us<br /><ul><li>Established in 1995
 Emphasis on FDA compliance and regulated industries </li></ul>Pharmaceutical, Medical Device and Biotech<br /><ul><li> He...
 Employee Owned ESOP</li></li></ul><li>Our People<br /><ul><li>Management/PMs average 10 years experience
Associates average 6 years experience
Permanent staff iscomprised of
ASQ Certified Quality Auditors
Certified Supply Chain Professionals (CSCP)
Quality Engineers and Managers
IT personnel
4-year technical degreed professionals</li></li></ul><li>Our Clients<br /><ul><li>Primarily Fortune 100 clients
100,000 + hrs compliance services in 2008-2010
>75% repeat business
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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.

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PharmTech QMS presentation

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

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