Date post: | 14-Jun-2015 |
Category: |
Health & Medicine |
Upload: | michael-stewart |
View: | 427 times |
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Quality & Life Cycle Management
Core Services
ROI
Trac
eabi
lity
Syste
ms
Technology
Integration
Quality Management
Systems
What We Do
“PharmTech turns a cost into an investment.”
About Us
• Established in 1995• Emphasis on FDA compliance and regulated industries
Pharmaceutical, Medical Device and Biotech• Headquartered in Libertyville, Illinois• Employee Owned ESOP
Our People• Management/PMs average 10 years experience• Associates average 6 years experience• Permanent staff is comprised of • ASQ Certified Quality Auditors• Certified Supply Chain Professionals (CSCP)• Quality Engineers and Managers• IT personnel• 4-year technical degreed professionals
Our Clients
• Primarily Fortune 100 clients• 100,000 + hrs compliance services in 2008-2010• >75% repeat business• Approximately 50% projects > 5,000 hrs• Current projects in California, Georgia, Illinois & Texas
Partnering Benefits
LeadershipSubject Matter ExpertsLed remediation of CAPA initiativesFDA AuditsThird Party Audits
Experience16 Years in Pharmaceutical Manufacturing as a Validation ProviderCreated and Implemented Audit Programs
(Policy, Master Schedule, Execution and Resolution)Nationwide access to resources
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
System Expertise• cGMP Compliance• Process Utilities/Process Equipment• Quality Assurance Documentation• Computer Systems/Automation (PLC/DCS)• Database System Design• Facility Design Criteria• Cleanroom/HVAC Design• Construction Management
Client Benefits• Diversified Technical Resource Pool• Experience-Based Knowledge• Solutions/Results• Lower Project Cost• Resource Planning Flexibility• Additional Resources• Best Value & Quality Service
The PharmTech Advantage
• Manufacturing/cGMP Experience• Established Network Relationships
• Flexible Fee Structure• Customized Protocol Formats • Technical Capabilities• Turnkey Capabilities
Why PharmTech?
Credentialed: 16 year track record in PharmaceuticalsFounded Traceability Solutions Group
Cost Effective: Lump Sum ProposalBudget 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!
Project Leadership & Innovation
Michael StewartTraceability & Supply Chain Visibility
Direct (847) 281-8924Cell (815) [email protected]
Next Steps…
Technology Integration
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