SOHM Inc (SHMN)

[hardlesson]

Wm. Dewey Rushing: "I am an ex-FDA and have been in the industry for over 30 years. Owner of BioValidation Services Inc (since 2009) providing FDA regulatory support in the form of remediations to client's quality system through evaluation and improvement plans. My experience covers Biotech development, Medical Devices Manufacturers, Pharmaceutical Facility and Process evaluations, Cell Therapy Technology and CMC requirements.

I own BioValidation Services Inc (since 2009) providing FDA regulatory support in the form of remediations to client's quality system through evaluation and improvement plans. I provide guidance to growing technologies in the form of tailored master plans so clients can evaluate, justify and track implementation of the basic tools required for regulatory reporting. My GOAL is to "plant the cGMP seed in R&D" by introducing quality system to help develop and document scientific progress."

https://www.linkedin.com/services/page/3684343141b8022b67/

https://ir.kiromic.com/news-releases/news-release-details/kiromic-biopharma-achieves-milestone-timely-completion-expanded

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International auditor, audited manufacturing operations and records at Sun Pharmaceuticals in India Faciliity in Halol as part of 483 remediation project.

Currently Acting VP of Quality for SOHM building new facility and technology development.International auditor, audited manufacturing operations and records at Sun Pharmaceuticals in India Faciliity in Halol as part of 483 remediation project. Currently Acting VP of Quality for SOHM building new facility and technology development.
Skills: international auditor · QMS · FDA GMP

Pharmaceutical Compliance Consultant (DiLisi Group)
Alcon, a Novartis company · Contract Alcon, a Novartis company · Contract
Oct 2010 - Dec 2010 · 3 mos Oct 2010 - Dec 2010 · 3 mos
Alcon Laboratories Fort Worth, Texas Alcon Laboratories Fort Worth, Texas
Process change validation support for a product with world wide distribution, so impact had to be evaluated and remediated for all countries. Prepared validation documents and summaries to be submitted for review and approval of process/product improvement. Process change validation support for a product with world wide distribution, so impact had to be evaluated and remediated for all countries. Prepared validation documents and summaries to be submitted for review and approval of process/product improvement.
Skills: FDA GMP · international laws · Process Improvement · Teamwork · Project Management

ZymoGenetics
•Prepared validation summary reports submitted to FDA in support of licensed product investigations.

Sr. Supervisor QA
Biogen Idec
•Authored the Facility Validation Master Plan for the new manufacturing building


Consumer Safety Investigator / Instructor
FDA · Full-time FDA · Full-time
Feb 1997 - Mar 2001 · 4 yrs 2 mosFeb 1997 - Mar 2001 · 4 yrs 2 mos
Los Angeles, California, United States

Consumer safety inspector in charge of identifying comodities for conformance to FDA regulations.
GMP instructor to spanish,
FDA representative to Mexico project,
Speaker at the Glove Manufacturer and Importers convention in Queen Mary, Long Beach, Ca.
Worked with Congress represenatives on pharmaceutical Mail importation investigation and new program.

Amgen
•Performed quarterly audits of the manufacturing and filling areas for compliance with cGMP`s.

Patheon - Mova
QC Microbiology Laboratory supervisor support new faciltiy and equipment validation in support of pharmaceutical solid and liquid dosage manufacturing.

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30 years.
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