Qualifications

1
Qualifications
Compliance Partners, LLC June 2007
2
History/Experience

• Established in 2002
• Emphasis on FDA regulated industry
• Management averages 25 years staffing experience
• Associates average 10 years experience

Compliance is our only business!
3
Basics

• Primarily Fortune 100 clients
• Offices in Chicago
• Database of approximately 10,000 validation
  candidates
• 92 repeat business
• Current or completed projects in California,
  Colorado, Florida, Georgia, Illinois, Indiana,
  Kansas, Massachusetts, Michigan, Minnesota,
  Missouri, Nebraska, New Jersey, New Mexico, North
  Carolina, Ohio, Oklahoma, Oregon, Pennsylvania,
  Utah, Virginia, Washington, Wisconsin, Puerto
  Rico, Scotland and Ireland

4
Why Compliance Partners?

• Experience
• Resources
• Global Work Environment
• Internal Quality Testing Systems
• Services Provided

5
GxP because..

• Experience, expertise and capability
• Long history with Fortune 100 Pharma
• Solutions to client challenges
• Technology to support remote site staffing
• Qualified peak load staffing
• Direct accountability to the Owner

6
Experience

• Successful relationship through national
  partnering agreements with several turnkey
  validation consulting firms

• Validation projects
• Abbott Laboratories, Abraxis (American
  Pharmaceutical Partners), Amgen, Angiotech,
  Aventis-Behring, Barr Laboratories, Baxter,
  Boston Scientific, Cardinal Health, Eli Lilly,
  IPS, Jacobs Engineering, Medtronic, Merial,
  Novartis, PDL BioPharma, Pfizer, Tyco-Mallinckrodt

• Significant experience in staffing projects
  nationally and abroad

7
Resources

• Current global database of resources
• 7000 consultants with validation experience on
  projects for facilities located in the USA
• 1,000 resources authorized to work overseas or
  living abroad
• Working relationship with national and
  international job boards

8
Global Work Environment

• Our infrastructure and database supports local
  staffing for remote sites
• More than 1,000 candidates available overseas

9
Internal Quality Systems

• Staffing Qualification
• On-line testing
• Reference checks
• Drug Screens
• Background Investigations (FDA Debarment,
  Education, Credit, Criminal, Workers Comp Claim
  history)

• Staffing/Testing
• Attract staff from industry
• Screen candidates on-line
• Conduct internal GMP Testing

10
Services

• Contract/Temporary staffing augmentation (TM)
• Permanent Placement (5)
• Contract to permanent (13)
• Payrolling independents (7)
• Project based work/Project Management (10)

• Cost/Pricing for services
• Flat Rate per Individual
• Markup percentage to labor rate
• Fee percentage of salary
• Time and material
• Fixed Bid

11
Staffing Disciplines
Validation

• Process
• Quality/QSR
• Cleaning
• Test Methods
• Analytical Methods
• Equipment
• Utilities
• Facilities

• Automation
• PLCs
• DCS, SCADA
• BMS

• CSV
• LIMS
• MRP/ERP
• R D
• Custom Software

12
Commissioning and Qualification
Staffing Disciplines

• Process Equipment IQ/OQ/PQ
• Utility/HVAC/Facilities IQ/OQ/PQ
• Analytical Equipment IQ/OQ/PQ
• Equipment/Utility/Facility Commissioning

13
Manufacturing Technologies
Staffing Disciplines

• Process Analytical Technology (PAT)
• S88/S95 Manufacturing Operations Control
• Global Technology Transfers
• Legacy Upgrades
• Electronic Batch Records
• DEA Controlled Drug Tracking

14
Segments Supported
Staffing Disciplines

• Bio-Processing
• Parenteral solutions (SVPs/LVPs)
• APIs/BPCs
• Non-Sterile liquid/Solid dosage forms
• Medical nutritionals

• Diagnostic devices
• Medical devices
• Animal health products
• RD, scale-up and pilot plant facilities
• Potent drug manufacture
• DEA/BATF controlled substances