Pharmaceutical & GMP Consulting for FDA & EU Regulatory Compliance.

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Pamela B. Smith
 
 Over 27 years of pharmaceutical experience. 

* Primary focus: Specializing in cGMP Auditing and Quality Systems Development/Review.
 
Quality Experience
*Miles Laboratories (now Talecris) - 9 years
  • QA Chemist

*Pharmacia and Upjohn - 8 years

  • QA Chemistry Specialist
  • QA Chemistry Supervisor
  • QA Compliance Manager
  • QA Laboratory Manager 

*Novo Nordisk Pharmaceutical Industries, Inc. - 4 years

  • QA Manager

*Smith Compliance Consulting - since 2001

  • Owner/Consultant

Professional Affiliations

  • Member Parenteral Drug Association
  • Member American Society for Quality

Certifications

  • ASQ Certified Quality Auditor
  • ASQ Certified Quality Manager

 

 

Robert B. Smith
 
 Over 30 years as a Pharmaceutical Manufacturing Professional.

* Primary focus: Specializing in Process Development & Optimization, Product Transfers & Scale-Ups, Production & Emulsion Technology, and Facility Start-up.
 
Pharmaceutical Manufacturing Experience
*Cutter Laboratories (now Talecris) - 6 years
  • Plasma Fractionation Technician
  • Mixing/Homogenization Coordinator

*Ajinomoto, USA - 3 years (Facility Start-up)

  • Purification, Mixing and Packaging Supervisor
  • Production and Materials Planner

*Kabi Pharmacia - 8 years (Facility Start-up)

  • Production Supervisor
  • Special Projects Supervisor
  • Production Section Manager

*Novo Nordisk Pharmaceuticals Industries, Inc. - 3 years (Facility Start-up)

  • Formulation/Sanitization Supervisor

*Fresenius Kabi (Formerly Pharmacia and Upjohn) - 9 years

  • Manufacturing Manager
  • Director of Technical Operations

*Hospira (Formerly Fresenius Kabi site) - 2 years

  • Manufacturing Manager, Technical Operations

*Smith Compliance Consulting - since 2006

  • Vice President/Consultant

Smith Compliance Consulting * 3646 E. Cotton Gin Dr.* Clayton * NC * 27527