About VCI

I not only use all the brains I have, but all that I can borrow.
- Woodrow Wilson

Validation and Compliance Institute, LLC, is a company of full-time professionals with a broad spectrum of expertise dedicated to the success of the customers they serve. We have offices in Michigan, and the major biotech areas: Boston, New York, San Francisco, and Southern California.

VCI professionals have hands-on knowledge in validation, production, quality, and R&D acquired by working in and managing these different areas. This operational expertise gives VCI a critical edge. The result for you is lower total cost and quicker market response times. VCI will save your company money through compliance and validation. Ask us how.

Operational experience provides VCI associates with the ability to add value to all aspects of your compliance program. From training to cultural transformation VCI is your partner for quality. Tap into the VCI team to satisfy your validation and compliance needs. Call (734) 274-4680 or email us at Ask VCI to find out how VCI can help you.

Some of our customers

  • University of Michigan Medical Innovation Center
  • Simco Electronics
  • Musculoskeletal Transplant Foundation
  • Danmar Products, Inc.
  • Lonza
  • BASF
  • Dow Corning
  • Beckman Coulter
  • Pointe Scientific
  • Bristol Meyers Squibb
  • Crown Technologies
  • Huhtamaki Group
  • King Orchards
  • New Chapter, Inc.
  • NSF International
  • Gerresheimer Glass
  • Bio-Rad Laboratories
  • Endoceutics
  • Novotech PTY LTD
  • Johnson & Johnson
  • Ecolab
  • US Department of Justice
  • Sandoz
  • Axiobionics
  • SPI Pharma

Dr. Norm Howe
VCI Senior Partner

Norm has held many management positions in FDA-regulated industries, most in production at BASF. He has led a number of cross-functional cost reduction, product development, and business optimization teams. He has led teams that have developed more than a dozen new products and installed many capital projects. He has taught Regulatory Science at the University of Michigan, Ann Arbor, and has authored articles on compliance, chemistry, and general management. He serves as an expert witness. He is a member of ISPE and the American Chemical Society. Norm Howe got his BS in chemistry at UC, Berkeley, and a PhD in chemistry at UCLA under Donald J. Cram.

 

 

Nicole Leitz

VCI Senior Partner

Nicole has focused her consultative efforts in the performance of audits for the 21 CFR regulated industries for food, dietary supplements, pharmaceuticals and medical devices.  She has also written and provided numerous training sessions on Quality System elements and practices for the 21 CFR regulated industries to corporate clients as well as at numerous national conventions.  In addition to these activities, Nicole has been employed as a remediation consultant where she has advised and written documentation such as SOP, WI, investigations, CAPAs and Complaints for corporate clients.  Lastly, Nicole has written, executed and trained industry personnel upon the regulatory aspects of Validation (V model) for software and analytical instrumentation.  Nicole Leitz has a Master of Science degree in Organic Chemistry from Bucknell University and a BS in Chemistry from Hope College.